Cancer Association of South Africa (CANSA)

Transcription

1 Cancer Assciatin f Suth Africa (CANSA) Fact Sheet n Childhd Sarcma f Sft Tissue Intrductin Sft tissue is a brad term ften used fr mesenchymal tissues that supprt and surrund mre well-defined rgans and specific tissues. The cells and structures f sft tissue are present thrughut the human bdy. The majr cell types f sft tissues are nn-epithelial and f mesdermal rigin, dented as mesenchymal cells. [Picture Credit: Sft Tissue Sarcma] In anatmy, sft tissues are the tissues that cnnect, supprt, r surrund ther structures and rgans f the bdy, nt being bne. Sft tissue includes tendns, ligaments, fascia, skin, fibrus tissues, fat, and synvial membranes (which are cnnective tissue), and muscles, nerves and bld vessels (which are nt cnnective tissue). (Wikipedia). Sft Tissue Sarcmas Sft tissue sarcmas are cancerus (malignant) tumurs that riginate in the sft tissues f the bdy. Sft tissues cnnect, supprt and surrund ther bdy structures. The sft tissues include muscle, fat, bld vessels, nerves, tendns and the lining f the jints (synvial tissues). A large variety f sft tissue sarcmas can ccur in these areas. Researched and Authred by Prf Michael C Herbst [D Litt et Phil (Health Studies); D N Ed; M Art et Scien; B A Cur; Dip Occupatinal Health] Apprved by Ms Elize Jubert, Chief Executive Officer [BA Scial Wrk (cum laude); MA Scial Wrk] May 2017 Page 1

2 Sft tissue sarcmas are nt cmmn. But sft tissue sarcmas are very serius, especially if diagnsed when the disease is mre advanced. [Picture Credit: Sft Tissue Sarcmas] Althugh there are varius types f sft tissue sarcma, they generally share similar characteristics, prduce similar symptms and are treated in similar ways. (May Clinic). Incidence f Sarcma f Sft Tissue in Suth Africa The Natinal Cancer Registry (2012) des nt prvide infrmatin n Sarcma f Sft Tissue. Signs and Symptms f Sarcma f Sft Tissue A sft tissue sarcma usually prduces n signs and symptms in its early stages. As the tumur grws, it may cause: A nticeable lump r swelling Pain, if it presses n nerves r muscles A blckage in the stmach r intestines r gastrintestinal bleeding if the tumur is lcated in the abdmen r digestive tract [Picture Credit: Sarcma f Sft Tissue] Other signs f sft tissue sarcma include the fllwing: A lump r mass - is the mst cmmn sft tissue sarcma sign. The lump will frm in the area in which the tumur is grwing, and there may be sme pain if it is pressing n a nerve r muscle. Even if the lump isn t painful, if it cntinues t grw in size, r if it is lcated deep within an extremity r bdy cavity, cnsult yur dctr. Uncmfrtable swelling - is anther sign f sft tissue sarcma, especially when it is lcated in the arms and legs. Limited mbility - can be a symptm f sft tissue sarcma. Sme tumurs can restrict mtin, such as thse fund in the hip, knee, shulder r hands. Skin lesins - can ccur when a sarcma tumur breaks thrugh the skin. Researched and Authred by Prf Michael C Herbst [D Litt et Phil (Health Studies); D N Ed; M Art et Scien; B A Cur; Dip Occupatinal Health] Apprved by Ms Elize Jubert, Chief Executive Officer [BA Scial Wrk (cum laude); MA Scial Wrk] May 2017 Page 2

3 Other symptms may be signs f sft tissue sarcma, because a sarcma tumur can frm almst anywhere in the bdy, and can therefre affect a variety f rgans. Fr example, sarcmas in the abdmen may cause abdminal pain, vmiting r cnstipatin, while sarcmas in the uterus may cause vaginal bleeding and/r abdminal pain. With gastrintestinal strmal tumurs (GISTs), yu may feel full after eating nly very small meals, r yu may vmit bld r have dark bwel mvements. Sft tissue sarcmas can ccur anywhere in the bdy, but the mst cmmn types f sft tissue sarcmas are gastrintestinal strmal tumurs and sft tissue sarcmas that affect the extremities. Abut 60 percent f sft tissue sarcmas ccur in the arms, legs, buttcks, hands r feet. Anther 20 percent ccur in the chest and abdmen. Abut 10 percent are fund in the head and neck. Sft tissue sarcmas g by a variety f names, depending n the tissue in which they riginate. Examples f sme sarcmas and their lcatins include: Rhabdmysarcma mre cmmn in children, this sarcma ccurs in the skeletal muscle Leimysarcma ccurs in the smth muscles muscles nt under vluntary cntrl. Fund mst cmmnly in the uterus, gastrintestinal tract r lining f bld vessels. Haemangisarcma affects bld vessels, especially in areas that have previusly received radiatin treatment. Kapsi s sarcma a malignancy that ccurs in bld vessel walls. Often affects peple with immune deficiencies, such as HIV/Aids. Lymphangisarcma affects the lymph vessels and is smetimes seen in a limb with chrnic swelling (lymphedema). This can be frm an area f prir radiatin therapy r certain chrnic infectins. Synvial sarcma tissue arund jints such as knees and ankles are affected. Typically ccurs in children and yung adults. Neurfibrsarcma ccurs in the peripheral nerves. The peripheral nervus system (PNS) is the part f the nervus system that cnsists f the nerves and ganglia utside f the brain and spinal crd. Lipsarcma fatty tissue, ften in the legs and trunk, is affected. Fibrsarcma fibrus tissue in the arms, legs r trunk may be affected. Malignant fibrus histicytma a fibrus tissue tumur mre likely t ccur in the legs. Dermatfibrsarcma grws in the tissue beneath the skin, and ften develps in the trunk r limbs. (May Clinic; Cancer Treatment Centers f America). Researched and Authred by Prf Michael C Herbst [D Litt et Phil (Health Studies); D N Ed; M Art et Scien; B A Cur; Dip Occupatinal Health] Apprved by Ms Elize Jubert, Chief Executive Officer [BA Scial Wrk (cum laude); MA Scial Wrk] May 2017 Page 3

4 Diagnsis f Sarcma f Sft Tissue The specialist will ask abut the patient s general health and any previus medical prblems. They will als examine the patient, which will include feeling the area where there is pain r swelling. The patient may be asked t have bld tests and a chest x-ray t check his/her general health. The dctrs will usually ask if they can take a sample f the lump, which will be examined under a micrscpe. This is knwn as a bipsy and is the nly way t tell whether the lump is a cancerus r nn-cancerus (benign) tumur. The patient may have ther tests and scans t assess the lump befre a bipsy. A bipsy can be dne in tw ways: a cre needle bipsy r a surgical bipsy. Cre needle bipsy - This is when a sample f cells is remved frm the lump using a needle. Several samples may be taken. Befre the bipsy is taken, a lcal anaesthetic is injected t numb the area. If the lump is near the surface f the bdy and can easily be felt, the dctr will prbably just feel it t guide the needle in. If the lump is deep within the bdy (such as in the abdmen) r is harder t feel, the dctr will use an ultrasund scan r smetimes a CT scan t guide the needle int the right place. A pathlgist (a dctr wh specialises in diagnsing disease by lking at bdy tissue and cells) will lk at the cells under a micrscpe t see whether they are benign r cancerus. If the lump is a sarcma, further tests may be dne n the sample t try t find ut exactly what type f sarcma it is. Smetimes, particularly with children, the bipsy is dne under a general anaesthetic while the patient is asleep. Fr mst peple, a cre needle bipsy will shw whether the lump is a sarcma r nt. Hwever, smetimes nt enugh cells are cllected t give a clear answer, and then a surgical bipsy is needed. Surgical bipsy - This is far less cmmnly used. It will nly be dne if a cre needle bipsy des nt give a definite result. A surgical knife (scalpel) is used t pen the area and remve a tissue sample frm the lump. If the lump is small enugh, all f it may be remved. A surgical bipsy may be dne under a lcal r general anaesthetic, depending n the psitin f the lump and hw deep it is within the bdy. As with a cre needle bipsy, the sample will be sent t the labratry s that it can be tested. Often a large number f studies will be dne even n a very small sample. It can take up t ten days t get all the results. This can be a wrrying time, but it is very imprtant that an accurate diagnsis is made s that the mst apprpriate treatment can be given. If the lump turns ut t be benign, the patient may nt need t have any mre treatment. If it is cancer, the dctr will discuss the treatment ptins with the patient and his/her parent(s) r guardian(s). (MacMillan Cancer Supprt). Researched and Authred by Prf Michael C Herbst [D Litt et Phil (Health Studies); D N Ed; M Art et Scien; B A Cur; Dip Occupatinal Health] Apprved by Ms Elize Jubert, Chief Executive Officer [BA Scial Wrk (cum laude); MA Scial Wrk] May 2017 Page 4

5 Grading and Staging f Sarcma f Sft Tissue The grade f a cancer gives an idea f hw quickly it might grw. Dctrs examine the cancer cells under a micrscpe and see hw they cmpare with nrmal cells. The grade helps the dctr decide if the patient needs further treatment after surgery. Grade 1 r lw-grade r well differentiated - The cancer cells lk similar t nrmal cells and usually grw slwly and are less likely t spread. Grade 2 r mderate- r intermediate-grade - The cancer cells lk mre abnrmal and are slightly faster-grwing. Grade 3 r high-grade r prly differentiated - The cancer cells lk very different frm nrmal cells and may grw mre quickly. Grading f sft tissue sarcmas can smetimes be difficult, especially fr the less cmmn types. The stage f a cancer describes its size and whether it has spread beynd its riginal area in the bdy. Several different staging systems may be used fr sft tissue sarcmas. Tw f the mst cmmnly used systems are a number staging system and the TNM staging system. Number staging In this system, there are fur main stages frm 1 t 4, which may be further subdivided: Stage 1A The cancer is small (5cm r less) and either lw-grade r the grade isn t knwn. It can either be clse t the surface f the bdy (superficial) r deep within the bdy. Stage 1B The cancer is larger than 5cm and either lw-grade r the grade isn t knwn. It can be either superficial r deep within the bdy. Stage 1 sft tissue sarcmas have nt spread t lymph ndes r ther parts f the bdy. Stage 2A The cancer is small (5cm r less) and either mderate- r high-grade. It can either be superficial r deep within the bdy. Stage 2B The cancer is larger than 5cm and mderate-grade. It can be either superficial r deep within the bdy. Stage 2 sft tissue sarcmas have nt spread t lymph ndes r ther parts f the bdy. Stage 3 The cancer is bigger than 5cm and high-grade. It can be either superficial r deep within the bdy, and has nt begun t spread OR The cancer is f any size, superficial r deep and f any grade, but it has spread t at least ne lymph nde, but nt t ther parts f the bdy. Stage 4 The cancer can be any size, superficial r deep, and f any grade. It may r may nt have spread t lymph ndes, but it has spread t anther part f the bdy such as the lungs, liver, bnes r sft tissues. This is knwn as secndary r metastatic cancer. Researched and Authred by Prf Michael C Herbst [D Litt et Phil (Health Studies); D N Ed; M Art et Scien; B A Cur; Dip Occupatinal Health] Apprved by Ms Elize Jubert, Chief Executive Officer [BA Scial Wrk (cum laude); MA Scial Wrk] May 2017 Page 5

6 The TNM System f Staging Dctrs put a number next t the T t describe the size and spread f the cancer. There are tw T stages fr sft tissue sarcmas and each is divided int a and b : T1 The tumur is 5cm r less in size. T1a The tumur is near the surface f the bdy (superficial). T1b The tumur is deep in the bdy. T2 The tumur is mre than 5cm in size. T2a The tumur is superficial. T2b The tumur is deep in the bdy. N fr affected lymph ndes This describes whether there are any lymph ndes near the tumur that have cancer in them. The N may have an X r a number written next t it, which gives extra infrmatin abut the ndes that were examined: NX The lymph ndes were nt examined. N0 The lymph ndes were examined but n cancer was fund. N1 There are cancer cells in at least ne lymph nde. If cancer cells have spread t the lymph ndes, the ndes are said t be psitive. It s uncmmn fr sft tissue sarcmas t spread t the lymph ndes. Psitive ndes (N1) are classified as a stage 3 sarcma. M fr metastasis Metastasis means that the cancer has spread t ther parts f the bdy such as the liver r lungs. The M may have a number written next t it, which gives extra infrmatin abut whether the cancer has spread r nt: M0 The cancer has nt spread t ther parts f the bdy. Researched and Authred by Prf Michael C Herbst [D Litt et Phil (Health Studies); D N Ed; M Art et Scien; B A Cur; Dip Occupatinal Health] Apprved by Ms Elize Jubert, Chief Executive Officer [BA Scial Wrk (cum laude); MA Scial Wrk] May 2017 Page 6

7 M1 The cancer has spread t anther part f the bdy. This is called secndary r metastatic cancer. The grade G f the cancer is als included in the TNM staging system fr sft tissue sarcmas: G1 The cancer is lw-grade G2 The cancer is mderate- r intermediate-grade G3 The cancer is high-grade GX The grade f the cancer is nt knwn (MacMillan Cancer Supprt). Treatment f Sarcma f Sft Tissue Fr small, lcalised sarcmas, surgery is the main treatment and may cure the disease. The patient is likely t have raditherapy afterwards if yur surgen culd nt cmpletely remve the sarcma and a wide brder f healthy tissue with n cancer cells. The raditherapy helps t stp the cancer cming back. If the patient has a larger tumur that has nt spread, he/she may have raditherapy r chemtherapy befre surgery. This treatment is designed t shrink the sarcma s that the patient will nt need s much surgery. This is nly dne with particular types f sarcma such as rhabdmysarcma and Ewings sarcma. Sme types f sarcma d nt respnd s well and are less likely t shrink. If the sarcma has spread, fr example t the lungs r liver, the may have surgery t remve the areas f spread. This can help t relieve symptms and keep the cancer under cntrl fr lnger. The patient may als have chemtherapy, raditherapy r any cmbinatin f these 3 types f treatment. Peple with a type f sarcma called gastrintestinal strmal tumur (GIST) may have the bilgical therapy drug imatinib (Glivec). If that stps wrking the dctr may recmmend anther bilgical therapy drug called sunitinib (Sutent). Surgery An peratin t remve the tumur is the main treatment fr mst sft tissue sarcmas. The aim f the surgery is t remve as much f the cancer as pssible. As well as remving the cancer, the surgen will remve a gd brder f surrunding healthy tissue. This is t try t make abslutely sure that they take away the whle sarcma. The brder is usually a few millimetres and is called a healthy margin r clear margin. This means the cancer is less likely t cme back in that area. At the same time, the surgen tries t take away as little healthy tissue as pssible, s that the impact f the surgery is as small as pssible. Researched and Authred by Prf Michael C Herbst [D Litt et Phil (Health Studies); D N Ed; M Art et Scien; B A Cur; Dip Occupatinal Health] Apprved by Ms Elize Jubert, Chief Executive Officer [BA Scial Wrk (cum laude); MA Scial Wrk] May 2017 Page 7

8 In the past, surgery fr sarcmas in the arm r leg ften meant remving the affected limb cmpletely (amputatin). But there have been big imprvements in surgical techniques, such as being able t re-attach tiny bld vessels (micrvascular surgery). Or smetimes surgens repair the peratin site with muscle frm ther parts f the bdy (a muscle flap) and skin grafts. These imprvements mean that amputatin can nw be avided in mst peple and may have limb sparing surgery instead. Fewer than 1 in 20 peple diagnsed with sarcma need amputatin these days. Unfrtunately, the size and psitin f a sft tissue sarcma in the arm r leg may still mean that amputatin is needed in sme peple. Surgery is used t remve stage 1, 2 and 3 sarcmas. If surgery t remve a sarcma is t difficult because f its psitin in the bdy, the patient may have raditherapy instead f surgery. In sme areas f the bdy, raditherapy may als be difficult because f the risk f damage t vital rgans. Many peple have raditherapy after surgery t try t kill ff any remaining sarcma cells and reduce the risk f the sarcma cming back. Whether a persn needs raditherapy r nt depends t sme extent n the grade and size f the sarcma. Raditherapy may nt be necessary after surgery if the persn has: A lw grade sarcma A very small sarcma A sarcma that is near the bdy surface (superficial) and nt buried deep in the tissues In sme situatins, surgery may als be used t remve sarcma that has spread t ther parts f the bdy (stage 4). This is mst ften dne when the sarcma has spread t the lungs r liver. There are als specialist surgical techniques t destry sarcma that has spread t the lung r liver. Raditherapy Raditherapy uses high energy rays t kill cancer cells. A patient may have raditherapy befre r after surgery fr sarcma, r n its wn as the main treatment. Treatment befre surgery is called ne adjuvant treatment. The aim is t shrink the tumur s that it is easier t remve. If the treatment is successful, the patient may be able t have a smaller peratin than it wuld therwise have been. Dctrs call this dwn staging the sarcma. But dctrs use raditherapy fr sarcma mstly after surgery, t kill ff any cancer cells that may have been left behind. They call this adjuvant raditherapy. If the patient has raditherapy after surgery, he/she usually begin their treatment between 6 and 12 weeks after peratin. This gives the area time t heal befre the raditherapy starts. Raditherapy treatment may last fr up t 7 weeks. The exact time will depend n the type, size and psitin f the sarcma. Smetimes, raditherapy may be the main treatment fr sarcma fr example with Ewing s tumurs, the patient may have raditherapy t try t cure the sarcma. But therwise raditherapy is usually used when the psitin f the cancer makes surgery t remve it t difficult. In this situatin, raditherapy is used t try t cntrl the sarcma and slw its grwth. Researched and Authred by Prf Michael C Herbst [D Litt et Phil (Health Studies); D N Ed; M Art et Scien; B A Cur; Dip Occupatinal Health] Apprved by Ms Elize Jubert, Chief Executive Officer [BA Scial Wrk (cum laude); MA Scial Wrk] May 2017 Page 8

9 Dctrs als use raditherapy t treat symptms r try t cntrl a sarcma that has already spread r has cme back since it was first treated. Chemtherapy Chemtherapy means having anti-cancer drugs. Fr sarcma, chemtherapy is mstly used t treat: Ewing's sarcmas Embrynal r alvelar rhabdmysarcma Children r yung adults with sarcma Sarcmas that have spread It is nt yet clear hw helpful chemtherapy is in ther situatins. A patient may be asked t jin a clinical trial if they are ffered chemtherapy. Sme studies have shwn that chemtherapy des nt help t reduce the chance f mst types f sarcma cming back after surgery. S chemtherapy is nt standard treatment after surgery. The chemtherapy drugs that dctrs mst ften use t treat sft tissue sarcmas are injected int a vein r given thrugh a drip. The patient may have a single chemtherapy drug r a cmbinatin f tw r mre drugs. Chemtherapy fr sft tissue sarcma can smetimes be given befre surgery t try t shrink the cancer. This may make it easier t remve but is nt standard treatment. This is called neadjuvant chemtherapy. Occasinally peple have chemtherapy t shrink their sarcma befre surgery using a technique called islated limb perfusin. This is a way f giving chemtherapy int just ne arm r leg. Chemtherapy can be used t treat symptms r try t slw dwn a cancer that has already spread r has cme back since it was first treated. Dctrs call this palliative chemtherapy. Research is cntinuing t try t imprve the success f this type f treatment. Bilgical therapy Bilgical therapy drugs wrk by stpping a series f chemical reactins that make the cancer cells grw and divide. Peple with gastrintestinal strmal tumurs (GISTs) that have spread may have a bilgical therapy drug called imatinib (Glivec). Studies have shwn that imatinib can wrk very well at cntrlling the grwth f GISTs fr several years r mre. (Cancer Research UK). Abut Clinical Trials Clinical trials are research studies that invlve peple. These studies test new ways t prevent, detect, diagnse, r treat diseases. Peple wh take part in cancer clinical trials have an pprtunity t cntribute t scientists knwledge abut cancer and t help in the develpment f imprved cancer treatments. They als receive state-f-the-art care frm cancer experts. Types f Clinical Trials Cancer clinical trials differ accrding t their primary purpse. They include the fllwing types: Researched and Authred by Prf Michael C Herbst [D Litt et Phil (Health Studies); D N Ed; M Art et Scien; B A Cur; Dip Occupatinal Health] Apprved by Ms Elize Jubert, Chief Executive Officer [BA Scial Wrk (cum laude); MA Scial Wrk] May 2017 Page 9

10 Treatment - these trials test the effectiveness f new treatments r new ways f using current treatments in peple wh have cancer. The treatments tested may include new drugs r new cmbinatins f currently used drugs, new surgery r radiatin therapy techniques, and vaccines r ther treatments that stimulate a persn s immune system t fight cancer. Cmbinatins f different treatment types may als be tested in these trials. Preventin - these trials test new interventins that may lwer the risk f develping certain types f cancer. Mst cancer preventin trials invlve healthy peple wh have nt had cancer; hwever, they ften nly include peple wh have a higher than average risk f develping a specific type f cancer. Sme cancer preventin trials invlve peple wh have had cancer in the past; these trials test interventins that may help prevent the return (recurrence) f the riginal cancer r reduce the chance f develping a new type f cancer. Screening - these trials test new ways f finding cancer early. When cancer is fund early, it may be easier t treat and there may be a better chance f lng-term survival. Cancer screening trials usually invlve peple wh d nt have any signs r symptms f cancer. Hwever, participatin in these trials is ften limited t peple wh have a higher than average risk f develping a certain type f cancer because they have a family histry f that type f cancer r they have a histry f expsure t cancer-causing substances (e.g., cigarette smke). Diagnstic - these trials study new tests r prcedures that may help identify, r diagnse, cancer mre accurately. Diagnstic trials usually invlve peple wh have sme signs r symptms f cancer. Quality f life r supprtive care - these trials fcus n the cmfrt and quality f life f cancer patients and cancer survivrs. New ways t decrease the number r severity f side effects f cancer r its treatment are ften studied in these trials. Hw a specific type f cancer r its treatment affects a persn s everyday life may als be studied. Where Clinical Trials are Cnducted Cancer clinical trials take place in cities and twns in dctrs ffices, cancer centres and ther medical centres, cmmunity hspitals and clinics. A single trial may take place at ne r tw specialised medical centres nly r at hundreds f ffices, hspitals, and centres. Each clinical trial is managed by a research team that can include dctrs, nurses, research assistants, data analysts, and ther specialists. The research team wrks clsely with ther health prfessinals, including ther dctrs and nurses, labratry technicians, pharmacists, dieticians, and scial wrkers, t prvide medical and supprtive care t peple wh take part in a clinical trial. Research Team The research team clsely mnitrs the health f peple taking part in the clinical trial and gives them specific instructins when necessary. T ensure the reliability f the trial s results, it is imprtant fr the participants t fllw the research team s instructins. The instructins may include keeping lgs r answering questinnaires. The research team may als seek t cntact the participants regularly after the trial ends t get updates n their health. Researched and Authred by Prf Michael C Herbst [D Litt et Phil (Health Studies); D N Ed; M Art et Scien; B A Cur; Dip Occupatinal Health] Apprved by Ms Elize Jubert, Chief Executive Officer [BA Scial Wrk (cum laude); MA Scial Wrk] May 2017 Page 10

11 Clinical Trial Prtcl Every clinical trial has a prtcl, r actin plan, that describes what will be dne in the trial, hw the trial will be cnducted, and why each part f the trial is necessary. The prtcl als includes guidelines fr wh can and cannt participate in the trial. These guidelines, called eligibility criteria, describe the characteristics that all interested peple must have befre they can take part in the trial. Eligibility criteria can include age, sex, medical histry, and current health status. Eligibility criteria fr cancer treatment trials ften include the type and stage f cancer, as well as the type(s) f cancer treatment already received. Enrlling peple wh have similar characteristics helps ensure that the utcme f a trial is due t the interventin being tested and nt t ther factrs. In this way, eligibility criteria help researchers btain the mst accurate and meaningful results pssible. Natinal and Internatinal Regulatins Natinal and internatinal regulatins and plicies have been develped t help ensure that research invlving peple is cnducted accrding t strict scientific and ethical principles. In these regulatins and plicies, peple wh participate in research are usually referred t as human subjects. Infrmed Cnsent Infrmed cnsent is a prcess thrugh which peple learn the imprtant facts abut a clinical trial t help them decide whether r nt t take part in it, and cntinue t learn new infrmatin abut the trial that helps them decide whether r nt t cntinue participating in it. During the first part f the infrmed cnsent prcess, peple are given detailed infrmatin abut a trial, including infrmatin abut the purpse f the trial, the tests and ther prcedures that will be required, and the pssible benefits and harms f taking part in the trial. Besides talking with a dctr r nurse, ptential trial participants are given a frm, called an infrmed cnsent frm, that prvides infrmatin abut the trial in writing. Peple wh agree t take part in the trial are asked t sign the frm. Hwever, signing this frm des nt mean that a persn must remain in the trial. Anyne can chse t leave a trial at any time either befre it starts r at any time during the trial r during the fllw-up perid. It is imprtant fr peple wh decide t leave a trial t get infrmatin frm the research team abut hw t leave the trial safely. The infrmed cnsent prcess cntinues thrughut a trial. If new benefits, risks, r side effects are discvered during the curse f a trial, the researchers must infrm the participants s they can decide whether r nt they want t cntinue t take part in the trial. In sme cases, participants wh want t cntinue t take part in a trial may be asked t sign a new infrmed cnsent frm. New interventins are ften studied in a stepwise fashin, with each step representing a different phase in the clinical research prcess. The fllwing phases are used fr cancer treatment trials: Phases f a Clinical Trial Phase 0. These trials represent the earliest step in testing new treatments in humans. In a phase 0 trial, a very small dse f a chemical r bilgic agent is given t a small number f peple (apprximately 10-15) t gather preliminary infrmatin abut hw the agent is Researched and Authred by Prf Michael C Herbst [D Litt et Phil (Health Studies); D N Ed; M Art et Scien; B A Cur; Dip Occupatinal Health] Apprved by Ms Elize Jubert, Chief Executive Officer [BA Scial Wrk (cum laude); MA Scial Wrk] May 2017 Page 11

12 prcessed by the bdy (pharmackinetics) and hw the agent affects the bdy (pharmacdynamics). Because the agents are given in such small amunts, n infrmatin is btained abut their safety r effectiveness in treating cancer. Phase 0 trials are als called micr-dsing studies, explratry Investigatinal New Drug (IND) trials, r early phase I trials. The peple wh take part in these trials usually have advanced disease, and n knwn, effective treatment ptins are available t them. Phase I (als called phase 1). These trials are cnducted mainly t evaluate the safety f chemical r bilgic agents r ther types f interventins (e.g., a new radiatin therapy technique). They help determine the maximum dse that can be given safely (als knwn as the maximum tlerated dse) and whether an interventin causes harmful side effects. Phase I trials enrl small numbers f peple (20 r mre) wh have advanced cancer that cannt be treated effectively with standard (usual) treatments r fr which n standard treatment exists. Althugh evaluating the effectiveness f interventins is nt a primary gal f these trials, dctrs d lk fr evidence that the interventins might be useful as treatments. Phase II (als called phase 2). These trials test the effectiveness f interventins in peple wh have a specific type f cancer r related cancers. They als cntinue t lk at the safety f interventins. Phase II trials usually enrl fewer than 100 peple but may include as many as 300. The peple wh participate in phase II trials may r may nt have been treated previusly with standard therapy fr their type f cancer. If a persn has been treated previusly, their eligibility t participate in a specific trial may depend n the type and amunt f prir treatment they received. Althugh phase II trials can give sme indicatin f whether r nt an interventin wrks, they are almst never designed t shw whether an interventin is better than standard therapy. Phase III (als called phase 3). These trials cmpare the effectiveness f a new interventin, r new use f an existing interventin, with the current standard f care (usual treatment) fr a particular type f cancer. Phase III trials als examine hw the side effects f the new interventin cmpare with thse f the usual treatment. If the new interventin is mre effective than the usual treatment and/r is easier t tlerate, it may becme the new standard f care. Phase III trials usually invlve large grups f peple (100 t several thusand), wh are randmly assigned t ne f tw treatment grups, r trial arms : (1) a cntrl grup, in which everyne in the grup receives usual treatment fr their type f cancer, r 2) an investigatinal r experimental grup, in which everyne in the grup receives the new interventin r new use f an existing interventin. The trial participants are assigned t their individual grups by randm assignment, r randmisatin. Randmisatin helps ensure that the grups have similar characteristics. This balance is necessary s the researchers can have cnfidence that any differences they bserve in hw the tw grups respnd t the treatments they receive are due t the treatments and nt t ther differences between the grups. Randmisatin is usually dne by a cmputer prgram t ensure that human chices d nt influence the assignment t grups. The trial participants cannt request t be in a particular grup, and the researchers cannt influence hw peple are assigned t the grups. Usually, neither the participants nr their dctrs knw what treatment the participants are receiving. Researched and Authred by Prf Michael C Herbst [D Litt et Phil (Health Studies); D N Ed; M Art et Scien; B A Cur; Dip Occupatinal Health] Apprved by Ms Elize Jubert, Chief Executive Officer [BA Scial Wrk (cum laude); MA Scial Wrk] May 2017 Page 12

13 Peple wh participate in phase III trials may r may nt have been treated previusly. If they have been treated previusly, their eligibility t participate in a specific trial may depend n the type and the amunt f prir treatment they received. In mst cases, an interventin will mve int phase III testing nly after it has shwn prmise in phase I and phase II trials. Phase IV (als called phase 4). These trials further evaluate the effectiveness and lng-term safety f drugs r ther interventins. They usually take place after a drug r interventin has been apprved by the medicine regulatry ffice fr standard use. Several hundred t several thusand peple may take part in a phase IV trial. These trials are als knwn as pst-marketing surveillance trials. They are generally spnsred by drug cmpanies. Smetimes clinical trial phases may be cmbined (e.g., phase I/II r phase II/III trials) t minimize the risks t participants and/r t allw faster develpment f a new interventin. Althugh treatment trials are always assigned a phase, ther clinical trials (e.g., screening, preventin, diagnstic, and quality-f-life trials) may nt be labelled this way. Use f Placebs The use f placebs as cmparisn r cntrl interventins in cancer treatment trials is rare. If a placeb is used by itself, it is because n standard treatment exists. In this case, a trial wuld cmpare the effects f a new treatment with the effects f a placeb. Mre ften, hwever, placebs are given alng with a standard treatment. Fr example, a trial might cmpare the effects f a standard treatment plus a new treatment with the effects f the same standard treatment plus a placeb. Pssible benefits f taking part in a clinical trial The benefits f participating in a clinical trial include the fllwing: Trial participants have access t prmising new interventins that are generally nt available utside f a clinical trial. The interventin being studied may be mre effective than standard therapy. If it is mre effective, trial participants may be the first t benefit frm it. Trial participants receive regular and careful medical attentin frm a research team that includes dctrs, nurses, and ther health prfessinals. The results f the trial may help ther peple wh need cancer treatment in the future. Trial participants are helping scientists learn mre abut cancer (e.g., hw it grws, hw it acts, and what influences its grwth and spread). Ptential harms assciated with taking part in a clinical trial The ptential harms f participating in a clinical trial include the fllwing: The new interventin being studied may nt be better than standard therapy, r it may have harmful side effects that dctrs d nt expect r that are wrse than thse assciated with standard therapy. Trial participants may be required t make mre visits t the dctr than they wuld if they were nt in a clinical trial and/r may need t travel farther fr thse visits. Researched and Authred by Prf Michael C Herbst [D Litt et Phil (Health Studies); D N Ed; M Art et Scien; B A Cur; Dip Occupatinal Health] Apprved by Ms Elize Jubert, Chief Executive Officer [BA Scial Wrk (cum laude); MA Scial Wrk] May 2017 Page 13

14 Crrelative research studies, and hw they are related t clinical trials In additin t answering questins abut the effectiveness f new interventins, clinical trials prvide the pprtunity fr additinal research. These additinal research studies, called crrelative r ancillary studies, may use bld, tumur, r ther tissue specimens (als knwn as bispecimens ) btained frm trial participants befre, during, r after treatment. Fr example, the mlecular characteristics f tumur specimens cllected during a trial might be analysed t see if there is a relatinship between the presence f a certain gene mutatin r the amunt f a specific prtein and hw trial participants respnded t the treatment they received. Infrmatin btained frm these types f studies culd lead t mre accurate predictins abut hw individual patients will respnd t certain cancer treatments, imprved ways f finding cancer earlier, new methds f identifying peple wh have an increased risk f cancer, and new appraches t try t prevent cancer. Clinical trial participants must give their permissin befre bispecimens btained frm them can be used fr research purpses. When a clinical trial is ver After a clinical trial is cmpleted, the researchers lk carefully at the data cllected during the trial t understand the meaning f the findings and t plan further research. After a phase I r phase II trial, the researchers decide whether r nt t mve n t the next phase r stp testing the interventin because it was nt safe r effective. When a phase III trial is cmpleted, the researchers analyse the data t determine whether the results have medical imprtance and, if s, whether the tested interventin culd becme the new standard f care. The results f clinical trials are ften published in peer-reviewed scientific jurnals. Peer review is a prcess by which cancer research experts nt assciated with a trial review the study reprt befre it is published t make sure that the data are sund, the data analysis was perfrmed crrectly, and the cnclusins are apprpriate. If the results are particularly imprtant, they may be reprted by the media and discussed at a scientific meeting and by patient advcacy grups befre they are published in a jurnal. Once a new interventin has prven safe and effective in a clinical trial, it may becme a new standard f care. (Natinal Cancer Institute). Medical Disclaimer This Fact Sheet is intended t prvide general infrmatin nly and, as such, shuld nt be cnsidered as a substitute fr advice, medically r therwise, cvering any specific situatin. Users shuld seek apprpriate advice befre taking r refraining frm taking any actin in reliance n any infrmatin cntained in this Fact Sheet. S far as permissible by law, the Cancer Assciatin f Suth Africa (CANSA) des nt accept any liability t any persn (r his/her dependants/estate/heirs) relating t the use f any infrmatin cntained in this Fact Sheet. Whilst CANSA has taken every precautin in cmpiling this Fact Sheet, neither it, nr any cntributr(s) t this Fact Sheet can be held respnsible fr any actin (r the lack theref) taken by any persn r rganisatin wherever they shall be based, as a result, direct r therwise, f infrmatin cntained in, r accessed thrugh, this Fact Sheet. Researched and Authred by Prf Michael C Herbst [D Litt et Phil (Health Studies); D N Ed; M Art et Scien; B A Cur; Dip Occupatinal Health] Apprved by Ms Elize Jubert, Chief Executive Officer [BA Scial Wrk (cum laude); MA Scial Wrk] May 2017 Page 14

15 Surces and References Cancer Research UK Cancer Treatment Centers f America MacMillan Cancer Supprt diagnsis/diagnsis.aspx diagnsis/staging/detailedstaging.aspx May Clinic Natinal Cancer Institute Sarcma f Sft Tissue Sft Tissue Sarcma &sa=x&ei=qgbuu6klfqqm7qac8h4ba&ved=0cayq_auaq&biw=1517&bih=714&dpr=0.9#facrc=_&imgdii=_&imgrc=snvlyjpem4z3zm%253a%3bafadjaiytfyaum%3bhttp%253 A%252F%252Fwww.flridaprtn.rg%252Fsites%252Fdefault%252Ffiles%252Fimages%2 52Fheaders%252Fnew_sarcma.jpg%3Bhttp%253A%252F%252Fwww.flridaprtn.rg%2 52Fcancers-treated%252Fsarcma%3B619%3B216 Sft Tissue Sarcmas AuWQ7Ab_74GwAQ&ved=0CAYQ_AUATgK&biw=1517&bih=714&dpr=0.9#facrc=_&imgdi i=_&imgrc=nkravc9zp8yfym%253a%3blschn2rda286km%3bhttp%253a%252f%252fl earnabutcancer.net%252fwpcntent%252fuplads%252f2012%252f05%252fcmmn-sites-f-sft-tissuesarcmas.png%3bhttp%253a%252f%252flearnabutcancer.net%252fsft-tissuesarcma.html%3b470%3b353 Wikipedia Researched and Authred by Prf Michael C Herbst [D Litt et Phil (Health Studies); D N Ed; M Art et Scien; B A Cur; Dip Occupatinal Health] Apprved by Ms Elize Jubert, Chief Executive Officer [BA Scial Wrk (cum laude); MA Scial Wrk] May 2017 Page 15