June Schema: S T R A I T I F Y. Age 1. <50 2. >50
|
|
- Percival Banks
- 5 years ago
- Views:
Transcription
1 June RTOG Protocol No: 9813 Protocol Status: ECOG Protocol No: R9813 Opened: June 16, 2000 NCCTG Protocol No: R9813 SWOG Protocol No: R9813 Title: A Phase / Randomized Study of Radiation Therapy and Temozolomide versus Radiation Therapy and BCNU for Anaplastic Astrocytoma (ND #60,265) Patient Population: - Histologically confirmed anaplastic astrocytoma or mixed oligodendroglial/astrocytic tumors if the oligodroglial component is < 25%. - No prior irradiation to the head, neck, or chemotherapy for any reason - Karnofsky performance status > 60 - Hgb > 10, absolute neutrophils > 1500, platelets > 150,000; liver function tests (AST/SGOT, alkaline phosphatase, total bilirubin < 2 x upper limit of normal); serum creatinine < 1.5 x normal. - Therapy must begin within 5 weeks after tissue diagnosis - No spinal cord tumors or spinal cord metastases - No prior invasive malignancy unless disease free > 5 years - No active infectious process - DLCO > 70% - Signed study-specific consent form prior to randomization Objective: 1. To compare overall survival. 2. To compare time to tumor progression. 3. To compare the relative toxicities of the two drug regimens. 4. To correlate molecular analyses with #1 and #2. Schema: S T R A T F Y Age 1. <50 2. >50 KPS Surgery 1. Biopsy only 2. Resection R A N D O M Z E Arm 1: Radiation Therapy: 59.4 Gy (1.8 Gy x 33 fractions, 5 days a week x 6 weeks) plus Temozolomide 200 mg/m 2 daily on days 1-5 of the first week of radiotherapy. Repeat Temozolomide every 28 days for a total of 12 cycles. Arm 2: Radiation Therapy: 59.4 Gy (1.8 Gy x 33 fractions, 5 days a week x 6 weeks) plus BCNU (80 mg/m 2 ) on days 1, 2, and 3 of the first week of radiotherapy and on days 56, 57, and 58 then every eight weeks for four cycles for a total of six cycles (maximum BCNU dose 1440 mg/m 2 ) Pilot #1, Arm 4: Pilot #2, Arm 5: Radiation Therapy: 59.4 (1.8 Gy x 33 fractions, 5 days a week x 6 weeks) plus BCNU 200 mg/m 2 on day 1 of radiotherapy and Temozolomide 150 mg/m 2 on days 1-5 of the first week of radiotherapy. Repeat every six weeks for a total of six cycles (maximum BCNU dose 1200 mg/m 2 ). (closed 3/15/01) Radiation Therapy: 59.4 (1.8 Gy x 33 fractions, 5 days a week x 6 weeks) plus BCNU 150 mg/m 2 on day 5 of radiotherapy and Temozolomide 150 mg/m 2 on days 1-5 of the first week of radiotherapy. Repeat every eight weeks for a total of six cycles. BCNU will be given on day 5 of Temozolomide in these cycles (maximum BCNU dose 900 mg/m 2 ). (closed 1/25/02)
2 June Study Chairs: Statisticians: Research Associate: Dosimetrist: Protocol Associate: Susan M. Chang, M.D. Gregory J. Cairncross, M.D. Mark. R. Gilbert, M.D. Jean-Paul Bahary, M.D. Carol A. Dolinskas, M.D. Ken Aldape, M.D. Peter Bushunow, M.D. (ECOG) Paul Brown, M.D. (NCCTG) Jan Buckner, M.D. (NCCTG) Geoffrey R. Barger, M.D. (SWOG) Charles Scott, Ph.D. Rebecca Paulus, B.S. Barbara Kaiser, R.N., C.C.R.P. Elizabeth Martin, B.S., R.T.T. Linda Walters-Page, M.A.. Summary: This study had two pilot arms in order to assess the toxicity and feasibility of combining BCNU and Temozolomide. Fifteen patients were enrolled on Pilot #1, which closed March 15, Fourteen patients were enrolled on Pilot #2, which closed January 25, The phase component was activated January The institutional accrual for the phase component is listed in Table 2.3. Pretreatment characteristics appear in Table 3.1. There were two grade 3 neurologic toxicities on Pilot #1 and none on Pilot #2. There were 5 grade 3-4 infections on Pilot #1 and one on Pilot #2 (Table 4.1). t has been determined that the combination of RT + Temozolomide + BCNU is not feasible, thus that arm has been discontinued.. Administrative nformation: Table 2.1 Patient Accrual Total Patients Entered on the Pilot Arms 29 Estimated number of patients needed to be randomized 454 Total randomized as of 5/1/03 17
3 June Table 2.2 Patient Accrual by Participating nstitution RTOG (N=42) Thomas Jefferson University Hospital 6 Baptist Hospital of Miami 2 Dixie Medical Cancer Center 2 Foundation for Cancer Res. and Edu. 3 ngalls Memorial Hospital 2 Kansas City CCOP 2 Natalie Warren Bryant CC at St. Francis Hosp. 2 Notre Dame Hospital/University of Montreal 2 SE Cancer Control Consortium, nc. CCOP 2 University of Utah Health Science Center 2 University of Wisconsin Hospital 2 Cancer Research for the Ozarks 1 Central llinois CCOP 1 Cleveland Clinic Foundation 1 Dartmouth Hitchcock Medical Center 1 Dayton CCOP 1 Joe Arrington Cancer Res. & Treatment Ctr. 1 LDS Hospital 1 Lutheran General Hospital 1 Metro-MN CCOP 1 The Wendt Regional CC of the Finley Hosp. 1 Univ. of California Davis Medical Center 1 University of Rochester 1 University of Texas Medical Branch 1 Vanderbilt University Medical Center 1 Wake Forest Univ. Baptist Medical Center 1 SWOG (N=2) Oregon Health Sciences Center 1 University of Arkansas Medical Center 1 ECOG (N=1) Rochester General Hospital 1 NCCTG (N=1) Cedar Rapids 1 Table 2.3 Randomized Accrual by Participating nstitution RTOG (N=14) Baptist Hospital of Miami 2 Notre Dame Hospital/University of Montreal 2 Dartmouth Hitchcock Medical Center 1 Dixie Medical Cancer Center 1 Foundation for Cancer Res. and Edu. 1 Kansas City CCOP 1 LDS Hospital 1 Natalie Warren Bryant CC at St. Francis Hosp. 1 The Wendt Regional CC of the Finley Hosp. 1 Thomas Jefferson University Hospital 1 University of Rochester 1 University of Utah Health Science Center 1 SWOG (N=2) Oregon Health Sciences Center 1 University of Arkansas Medical Center 1 NCCTG (N=1) Cedar Rapids 1
4 June Table 2.4 Status of Cases Pilot #1 Pilot #2 RT + Temozolomide RT + BCNU Total Patients Entered Cancelled 0 1* 0 0 No On-study Form Eligible and Analyzable *CN Arm Reason 27 Pilot #2 Cancelled: Patient progressed prior to receiving treatment, refused any treatment. Pretreatment Characteristics: Table 3.1 Pretreatment Characteristics Pilot #1 (N=15) Pilot #2 (N=13) RT + Temozolomide (N=1) RT + BCNU (N=2) Age <50 8 (53%) 10 (77%) 0 1 (50%) 50 7 (47%) 3 (23%) 1(100%) 1 (50%) Gender Male 10 (67%) 7 (54%) 1(100%) 1 (50%) Female 5 (33%) 6 (46%) 0 1 (50%) Race White 13 (87%) 11 (85%) 1(100%) 2(100%) Hispanic 2 (13%) 1 ( 8%) 0 0 African American 0 1 ( 8%) 0 0 KPS 60 2 (13%) (53%) 3 (23%) 1(100%) 1 (50%) (33%) 10 (77%) 0 1 (50%) Surgery Biopsy 7 (47%) 5 (38%) 0 1 (50%) Partial Resection 5 (33%) 3 (23%) 1(100%) 1 (50%) Total Resection 3 (20%) 5 (38%) 0 0 Neurologic Function No Symptoms 4 (27%) 4 (31%) 0 0 Minor Symptoms 5 (33%) 7 (54%) 1(100%) 2(100%) Moderate Symptoms 6 (40%) 2 (15%) 0 0
5 June V. Toxicities: Table 4.1 Toxicities Pilot #1 N=15 Grade Pilot #2 N=13 Grade Auditory/Hearing Blood/Bone Marrow Thrombocytopenia Cardiovascular (General) * Constitutional Symptoms Dermatology/Skin 4 4 1* Gastrointestinal Hepatic nfection/febrile Neutropenia Lymphatics Metabolic/Laboratory Musculoskeletal Neurology 2 2 2* Ocular/Visual Pain Pulmonary 1 3 1* Renal/Genitourinary Maximum Toxicity per Patient Maximum Non-Hematologic Toxicity per Patient *CN Arm Toxicity Grade Most Recent Cycle of Chemotherapy Days from Start of RT 3 Pilot #1 Pulmonary: Dyspnea Pilot #1 Dermatology: Rash/desquamation Pilot #1 Neurology: Confusion Pilot #1 Cardiovascular (General): Thrombosis/embolism 4 2 Unknown 15 Pilot #1 Neurology: Vertigo
January Schema: S T R A T I F Y. Age 1. <50 2. >50
January 2004 9813-1 RTOG Protocol No: 9813 Protocol Status: ECOG Protocol No: R9813 Phase I: Opened June 16, 2000 NCCTG Protocol No: R9813 Closed January 25, 2002 SWOG Protocol No: R9813 Phase III: Opened
More informationJune Patient Population:
June 2003 9802-1 RTOG Protocol No: 9802 Protocol Status: ECOG Protocol No: R9802 Opened: October 31, 1998 NCCT Protocol No: R9802 Closed: June 27, 2002 SWOG Protocol No: R9802 Title: A Phase II Study of
More informationJune Arm 1 = Observe R A N D O M I Z E
June 2004 9802-1 RTOG Protocol No: 98-02 Protocol Status: ECOG Protocol No: R9802 Opened: October 31, 1998 NCCT Protocol No: R9802 Closed: June 27, 2002 SWOG Protocol No: R9802 Title: A Phase II Study
More informationJanuary NCCTG Protocol No: N0628 Opened: November 27, 2007 CALGB Protocol No: ECOG Protocol No: R0617
January 2010 0617-1 RTOG Protocol No: 0617 Protocol Status: NCCTG Protocol No: N0628 Opened: November 27, 2007 CALGB Protocol No: 30609 ECOG Protocol No: R0617 Title: A Randomized Phase III Comparison
More informationArm A: Induction Gemcitabine 1000 mg/m 2 IV once a week for 6 weeks.
ECOG-4201 (RTOG Endorsed) ECOG 4201 Pancreas (RTOG Endorsed)-1 Protocol Status: Opened: April 10, 2003 Closed: December 15, 2005 Title: A Randomized Phase III Study of Gemcitabine in Combination with Radiation
More informationJune 2009 Respiratory Committee CALGB 30610
30610 Phase III comparison of thoracic radiotherapy regimens in patients with limited small cell lung cancer also receiving cisplatin and etoposide Activated: March 15, 2008 Study Chairpersons: J. Bogart
More informationChemotherapy plus Radiotherapy versus Radiotherapy Alone for Patients with Anaplastic Oligodendroglioma: Long Term Results of RTOG 9402
Chemotherapy plus Radiotherapy versus Radiotherapy Alone for Patients with Anaplastic Oligodendroglioma: Long Term Results of RTOG 9402 Gregory Cairncross, Meihua Wang, Edward Shaw, Berndt Scheithauer
More informationObjectives Primary Objective: Secondary Objectives For T4 a, b, c tumors:
Z1031 A randomized phase III trial comparing 16 to 18 weeks of neoadjuvant exemestane (25mg daily), letrozole (2.5mg), or anastrozole (1mg) in postmenopausal women with clinical stage II and III estrogen
More informationNCCTG Status Report for Study N April 2008
Phase II Randomized Study of Pemetrexed With Sorafenib Versus Pemetrexed lone as Second-line Therapy in Patients With dvanced Non-Small Cell Lung Cancer Purpose of - Primary Study: 1) To compare the progression-free
More informationNCCTG Status Report for Study N September 2007
Phase I/II Study of Concurrent Chemotherapy and Escalating Doses 3-D Conformal Radiotherapy (RT) Followed by Three Cycles of Chemotherapy for Unresectable Non-Small Cell Lung Cancer (NSCLC) Using a New
More information6 cycles* January Opened: January 17, 2006
January 2008 0525-1 RTOG Protocol No: 0525 Protocol Status: Opened: January 17, 2006 Title: Phase III Trial Comparing Conventional Adjuvant Temozolomide with Dose-Intensive Temozolomide in Patients with
More informationPROCARBAZINE, lomustine, and vincristine (PCV) is
RAPID PUBLICATION Procarbazine, Lomustine, and Vincristine () Chemotherapy for Anaplastic Astrocytoma: A Retrospective Review of Radiation Therapy Oncology Group Protocols Comparing Survival With Carmustine
More informationGOG PROTOCOL #209. David Miller, MD, Gini Fleming, MD, Richard Zaino, MD, and David Cella, PhD
GOG PROTOCOL #209 PROTOCOL Study Chairs Statistician Data Coordinator Randomized Phase III Trial of Doxorubicin/Cisplatin/Paclitaxel and G-CSF Versus Carboplatin/Paclitaxel in Patients with Stage III and
More informationEORTC (RTOG 0834 Endorsed) Opened: July 22, 2009
January 2011 0834-1 EORTC 26053 22054 (RTOG 0834 Endorsed) Protocol Status: Opened: July 22, 2009 Title: Phase III Trial on Concurrent and Adjuvant Temozolomide Chemotherapy in Non-1P/19Q Deleted Anaplastic
More informationGOG PROTOCOL #209 GOG 209
GOG PROTOCOL #209 PROTOCOL Study Chairs Statistician Data Coordinator Randomized Phase III Trial of Doxorubicin/Cisplatin/Paclitaxel and G-CSF Versus Carboplatin/Paclitaxel in Patients with Stage III and
More informationNCCTG Status Report for Study N May 2010
Phase I/II Study of Vorinostat (Suberoylanilide Hydroxamic cid SH), Temozolomide, and Radiation Therapy in Patients with Newly Diagnosed Glioblastoma Purpose of - Phase I Study: 1) To determine the maximum
More informationFeasibility Trial of Optune for Children with Recurrent or Progressive Supratentorial High-Grade Glioma and Ependymoma
Feasibility Trial of Optune for Children with Recurrent or Progressive Supratentorial High-Grade Glioma and Ependymoma ABSTRACT Recurrent or progressive pediatric CNS tumors generally have a poor prognosis
More informationS0106 Phase III. Coordinating Group: SWOG
S0106 Phase III Coordinating Group: SWOG A Phase III Study of the Addition of Gemtuzumab Ozogamicin (Mylotarg ) Induction Therapy Versus Standard Induction with Daunomycin and Cytosine Arabinoside Followed
More informationProtocol Abstract and Schema
Protocol Abstract and Schema This is a phase I/II study to determine: 1) the maximum tolerated dose (MTD) or recommended phase II dose of ABT-888 in combination with radiation therapy, and 2) the efficacy
More informationEASTERN COOPERATIVE ONCOLOGY GROUP
EASTERN COOPERATIVE ONCOLOGY GROUP E5204 INTERGROUP RANDOMIZED PHASE III STUDY OF POSTOPERATIVE OXALIPLATIN, 5-FLUOROURACIL AND LEUCOVORIN VS OXALIPLATIN, 5-FLUOROURACIL, LEUCOV- ORIN AND BEVACIZUMAB FOR
More informationAbstract and Schema. Phase 1 and Pharmacokinetic Study of AZD6244 for Recurrent or Refractory Pediatric Low Grade Glioma
Abstract and Schema Phase 1 and Pharmacokinetic Study of AZD6244 for Recurrent or Refractory Pediatric Low Grade Glioma Description and Rationale: Low grade gliomas are among the most common primary CNS
More informationProtocol Abstract and Schema
Protocol Abstract and Schema A Phase 1 and Phase II Study of AZD6244 for Recurrent or Refractory Pediatric Low Grade Glioma Description and Rationale: Low grade gliomas are among the most common primary
More informationHSV1716 Dose levels and Cohort size Dose level No of Patients HSV1716 Dosage 1* 3 to 6 1 ml of 1 x 10 5 infectious units HSV1716 per ml 2
Abstract and Schema: Description and Rationale: Pediatric high grade gliomas have a progressive initial course and high risk of relapse/ progression; making the 5-year overall survival rate 15-35% with
More informationProtocol Abstract and Schema
Protocol Abstract and Schema Phase II study of Bevacizumab plus Irinotecan (Camptosar ) in Children with Recurrent, Progressive, or Refractory Malignant Gliomas, Diffuse/Intrinsic Brain Stem Gliomas, Medulloblastomas,
More informationAbstract and Schema. Phase 1 and Pharmacokinetic Study of AZD6244 for Recurrent or Refractory Pediatric Low Grade Glioma
Abstract and Schema Phase 1 and Pharmacokinetic Study of AZD6244 for Recurrent or Refractory Pediatric Low Grade Glioma Description and Rationale: Low grade gliomas are among the most common primary CNS
More informationCollection of Recorded Radiotherapy Seminars
IAEA Human Health Campus Collection of Recorded Radiotherapy Seminars http://humanhealth.iaea.org The Role of Radiosurgery in the Treatment of Gliomas Luis Souhami, MD Professor Department of Radiation
More informationCNAJ12TZRT. Protocol Code. Neuro-Oncology. Tumour Group. Dr. Brian Thiessen. Contact Physician
BC Cancer Protocol Summary for Concomitant (Dual Modality) and 12 Cycles of Adjuvant Temozolomide for Newly Diagnosed Astrocytomas and Oligodendrogliomas with Radiation Protocol Code Tumour Group Contact
More informationJune 2009 Breast Committee CALGB 40502
CALGB 40502/CTSU 40502 A randomized phase III trial of weekly paclitaxel compared to weekly nanoparticle albumin bound nabpaclitaxel or ixabepilone combined with bevacizumab as first-line therapy for locally
More informationObjectives Primary Objectives:
Z1031 A randomized phase III trial comparing 16 to 18 weeks of neoadjuvant exemestane (25mg daily), letrozole (2.5mg), or anastrozole (1mg) in postmenopausal women with clinical stage II and III estrogen
More informationCancer Research Group Version Date: November 5, 2015 NCI Update Date: January 15, Schema. L O Step 1 1,2
Cancer esearch roup ev. 6/14, 2/15, 1/16 Step 2 Schema 5 Arm A: (7 weeks) Step 1 1,2 N Accrual: 515 S Arm S ransoral esection dissections S A N D M Z 4 ntermediate isk 7 Stratify: = 10 pk-yr vs. > 10 pk-yr
More informationPlattenepithelkarzinom des Ösophagus, 1 st -line
Plattenepithelkarzinom des Ösophagus, 1 st -line AIO-STO-0309 An open-label, randomized phase III trial of cisplatin and 5-fluorouracil with or without panitumumab for patients with nonresectable, advanced
More informationBC Cancer Protocol Summary for Treatment of Elderly Newly Diagnosed Glioma Patient with Concurrent and Adjuvant Temozolomide and Radiation Therapy
BC Cancer Protocol Summary for Treatment of Elderly Newly Diagnosed Glioma Patient with Concurrent Adjuvant Temozolomide Radiation Therapy Protocol Code Tumour Group Contact Physician CNELTZRT Neuro-Oncology
More informationSubject ID: I N D # # U A * Consent Date: Day Month Year
IND Study # Eligibility Checklist Pg 1 of 15 Instructions: Check the appropriate box for each Inclusion and Exclusion Criterion below. Each criterion must be marked and all protocol criteria have to be
More informationSponsor / Company: Sanofi Drug substance(s): SAR (iniparib)
These results are supplied for informational purposes only. Prescribing decisions should be made based on the approved package insert in the country of prescription. Sponsor / Company: Sanofi Drug substance(s):
More informationJune Opened: January 17, 2006 Closed: June 13, 2008
June 2009 0525-1 RTOG Protocol No: 0525 Protocol Status: Opened: January 17, 2006 Closed: June 13, 2008 Title: Phase III Trial Comparing Conventional Adjuvant Temozolomide with Dose-Intensive Temozolomide
More informationSUMMARY OF CHANGES Amendment 6, Version Date: March 29, 2010 [Broadcast: April 8, 2010]
Amendment 6, Version Date: March 29, 2010 [Broadcast: April 8, 2010] RTOG 0233, "A Phase II Randomized Trial for Patients With Muscle-Invading Bladder Cancer Evaluating Transurethral Surgery and BID Irradiation
More informationProtocol Abstract and Schema
Protocol Abstract and Schema A Phase I Trial of p28 (NSC745104), a Non-HDM2 mediated peptide inhibitor of p53 ubiquitination in pediatric patients with recurrent or progressive CNS tumors Description and
More information(7) VITAL SIGNS (8) LEVEL OF CONSCIOUSNESS (9) MENTAL STATUS (10) SPEECH (11) VISION (12) FUNDUS (PAPILLEDEMA)
Radiation Therapy Oncology Group Phase II CNS Lymphoma Follow-Up Form RTOG Study No. 1114 Case # Amended Data Yes INSTRUCTIONS: Submit this form as indicated in the protocol. All dates need to be recorded
More informationPhase II Trial of Observation for Low-Risk Meningiomas and of Radiotherapy for Intermediate- and High-Risk Meningiomas
RTOG 0539 Phase II Trial of Observation for Low-Risk Meningiomas and of Radiotherapy for Intermediate- and High-Risk Meningiomas Volume 4, Issue 2 September 2012 I N T HIS I SSUE Thoughts From the Chair
More informationWARNING, CONTRAINDICATIONS, WARNINGS AND PRECAUTIONS,
Celgene Corporation 86 Morris Avenue Summit, New Jersey 07901 Tel 908-673-9000 Fax 908-673-9001 October 2012 NEW Indication Announcement for ABRAXANE for Injectable Suspension (paclitaxel protein-bound
More informationThe Clinical Research E-News
Volume 3: ISSUE 3: February 16, 2011 The Clinical Research E-News Now Open: RTOG 0631, Phase II/III Study of Image-Guided Radiosurgery/SBRT for Localized Spine Metastasis RTOG 1010, A Phase III Trial Evaluating
More informationChemoradiation (CRT) Safety Analysis of ACOSOG Z6041: A Phase II Trial of Neoadjuvant CRT followed by Local Excision in ut2 Rectal Cancer
Chemoradiation (CRT) Safety Analysis of ACOSOG Z6041: A Phase II Trial of Neoadjuvant CRT followed by Local Excision in ut2 Rectal Cancer Emily Chan, Qian Shi, Julio Garcia-Aguilar, Peter Cataldo, Jorge
More informationNRG ONCOLOGY NRG-CC003
NRG ONCOLOGY NRG-CC003 A Randomized Phase II/III Trial of Prophylactic Cranial Irradiation with or without Hippocampal Avoidance for Small Cell Lung Cancer SCHEMA Histologic proof or unequivocal cytologic
More informationNeuro-Oncology Program
Neuro-Oncology Program The goals of the Neuro-oncology Committee are: 1) to improve duration and quality of life of brain tumor patients; 2) to assess disease and treatment-related effects on neurocognitive
More informationSupplementary Appendix
Supplementary Appendix This appendix has been provided by the authors to give readers additional information about their work. Supplement to: Llovet JM, Ricci S, Mazzaferro V, et al. Sorafenib in advanced
More informationThe 2010 Gastrointestinal Cancers Symposium Oral Abstract Session: Cancers of the Pancreas, Small Bowel and Hepatobilliary Tract
The 2010 Gastrointestinal Cancers Symposium : Cancers of the Pancreas, Small Bowel and Hepatobilliary Tract Abstract #131: Phase I study of MK 0646 (dalotuzumab), a humanized monoclonal antibody against
More information21/03/2017. Disclosure. Practice Changing Articles in Neuro Oncology for 2016/17. Gliomas. Objectives. Gliomas. No conflicts to declare
Practice Changing Articles in Neuro Oncology for 2016/17 Disclosure No conflicts to declare Frances Cusano, BScPharm, ACPR April 21, 2017 Objectives Gliomas To describe the patient selection, methodology
More informationIrinotecan. Class:Camptothecin. Indications : _Cervical cancer. _CNS tumor. _Esophageal cancer. _Ewing s sarcoma. _Gastric cancer
Irinotecan Class:Camptothecin Indications : _Cervical cancer _CNS tumor _Esophageal cancer _Ewing s sarcoma _Gastric cancer _Nonsmall cell lung cancer _Pancreatic cancer _Small cell lung cancer _Colorectal
More informationPrimary Endpoint The primary endpoint is overall survival, measured as the time in weeks from randomization to date of death due to any cause.
CASE STUDY Randomized, Double-Blind, Phase III Trial of NES-822 plus AMO-1002 vs. AMO-1002 alone as first-line therapy in patients with advanced pancreatic cancer This is a multicenter, randomized Phase
More informationPRESURGICAL PLANNING. Strongly consider neuropsychological evaluation before functional imaging study Strongly consider functional imaging study
NOTE: Consider Clinical Trials as treatment options for eligible patients. Page 1 of 6 RADIOLOGICAL PRESENTATION PRESURGICAL PLANNING TREATMENT Imaging study suggestive of glioma 1 Left hemisphere speech/motor
More informationAdjuvant Therapy in Locally Advanced Head and Neck Cancer. Ezra EW Cohen University of Chicago. Financial Support
Adjuvant Therapy in Locally Advanced Head and Neck Cancer Ezra EW Cohen University of Chicago Financial Support This program is made possible by an educational grant from Eli Lilly Oncology, who had no
More informationGOOVIPPC. Protocol Code: Gynecology. Tumour Group: Paul Hoskins. Contact Physician: James Conklin. Contact Pharmacist:
BCCA Protocol Summary for Primary Treatment of Stage III less than or equal to 1 cm Visible Residual Invasive Epithelial Ovarian Cancer or Stage I Grade 3 or Stage II Grade 3 Papillary Serous Ovarian Cancer
More informationACOSOG (NCCTG, CALGB) Alliance Thoracic Committee Kemp H. Kernstine, MD PhD
ACOSOG (NCCTG, CALGB) Alliance Thoracic Committee Kemp H. Kernstine, MD PhD 7-12-12 ACOSOG Thoracic Committee Chair: Bryan Meyers, M.D., MPH Vice Chairs: Malcolm Brock, MD Tom DiPetrillo, M.D. Ramaswamy
More informationSynopsis. Study Phase and Title: Study Objectives: Overall Study Design
Synopsis Study Phase and Title: Study Objectives: Overall Study Design Phase III randomized sequential open-label study to evaluate the efficacy and safety of sorafenib followed by pazopanib versus pazopanib
More informationFinal Results of Phase III Trial in Regionally Advanced Unresectable Non-Small Cell Lung Cancer*
Final Results of Phase III Trial in Regionally Advanced Unresectable Non-Small Cell Lung Cancer* Radiation Therapy Oncology Group, Eastern Cooperative Oncology Group, and Southwest Oncology Group William
More informationWelcome to. American College of Surgeons. Clinical Research Program (ACS-CRP) Breast Surgical Trial Webinar
American College of Surgeons Clinical Research Program Kelly K. Hunt, M.D. Program Director Welcome to American College of Surgeons Clinical Research Program (ACS-CRP) Breast Surgical Trial Webinar Moderator:
More informationJanuary Opened: April 15, 2009
January 2011 0825-1 RTOG Protocol No: 0825 Protocol Status: Opened: April 15, 2009 Title: Phase III Double-Blind Placebo-Controlled Trial of Conventional Concurrent Chemoradiation and Adjuvant Temozolomide
More informationDocetaxel. Class: Antineoplastic agent, Antimicrotubular, Taxane derivative.
Docetaxel Class: Antineoplastic agent, Antimicrotubular, Taxane derivative. Indications: -Breast cancer: -Non small cell lung cancer -Prostate cancer -Gastric adenocarcinoma _Head and neck cancer Unlabeled
More informationClinialTrials.gov Identifier: sanofi-aventis. Sponsor/company: Date: 18 February 2008
These results are supplied for informational purposes only. Prescribing decisions should be made based on the approved package insert in the country of prescription Sponsor/company: sanofi-aventis ClinialTrials.gov
More informationSUMMARY OF CHANGES Amendment 5, Version Date: March 24, 2010 Broadcast: 4/6/10
Amendment 5, Version Date: March 24, 2010 Broadcast: 4/6/10 RTOG 0239, "A Phase II Study Of Accelerated High Dose Thoracic Irradiation With Concurrent Chemotherapy For Patients With Limited Small Cell
More informationTrabectedin in ASTS. Le Cesne A, et al. J Clin Oncol. 2018;36(suppl): Abstract
Results of a Prospective Randomized Phase III T-SAR Trial Comparing Trabectedin vs Best Supportive Care (BSC) in Patients With Pretreated Advanced Soft Tissue Sarcoma (ASTS) Abstract 11508 Le Cesne A,
More informationBCCA Protocol Summary for Curative Combined Modality Therapy for Carcinoma of the Anal Canal Using Mitomycin, Capecitabine and Radiation Therapy
BCCA Protocol Summary for Curative Combined Modality Therapy for Carcinoma of the Anal Canal Using Mitomycin, and Radiation Therapy Protocol Code: Tumour Group: Contact Physician: GICART Gastrointestinal
More informationAntiemetic protocol for low-moderately emetogenic chemotherapy (see SCNAUSEA)
BC Cancer Protocol Summary for First Line Treatment of Locally Advanced Metastatic Pancreatic Cancer with Gemcitabine Protocol Code Tumour Group Contact Physician GIPGEMABR Gastrointestinal GI Systemic
More informationPhase I Trial of Siplizumab in CD-2 Positive Lymphoproliferative Disease
Phase I Trial of Siplizumab in CD-2 Positive Lymphoproliferative Disease J E Janik 1, D O Mahony 1, JC Morris 1, L Moses 1, D O Hagan 1, W Gao 1, M A Stetler-Stevenson 1, M Taylor 2, L Hammershaimb 2 T
More informationSpecial pediatric considerations are noted when applicable, otherwise adult provisions apply.
DRUG NAME: Lomustine SYNONYM(S): CCNU 1 COMMON TRADE NAME(S): CeeNU CLASSIFICATION: alkylating agent Special pediatric considerations are noted when applicable, otherwise adult provisions apply. MECHANISM
More informationContemporary Management of Glioblastoma
Contemporary Management of Glioblastoma Incidence Rates of Primary Brain Tumors Central Brain Tumor Registry of the United States, 1992-1997 100 Number of Cases per 100,000 Population 10 1 0.1 x I x I
More informationHypofractionated radiation therapy for glioblastoma
Hypofractionated radiation therapy for glioblastoma Luis Souhami, MD, FASTRO Professor McGill University Department of Oncology, Division of Radiation Oncology Montreal Canada McGill University Health
More informationNCCTG Status Report for Study N May 2010
MARVEL: Marker Validation of Erlotinib in Lung Cancer - A Phase III Biomarker Validation Study of Second-Line Therapy in Patients With Advanced Non-Small Cell Lung Cancer (NSCLC) Randomized to Pemetrexed
More informationRadio-chemo-immunotherapy using the IDO-inhibitor indoximod for childhood brain cancer (NCT )
Radio-chemo-immunotherapy using the IDO-inhibitor indoximod for childhood brain cancer (NCT02502708) Theodore S. Johnson, M.D., Ph.D. Pediatric Immunotherapy Program Medical College of Georgia (MCG) Georgia
More informationManagement of Brain Metastases Sanjiv S. Agarwala, MD
Management of Brain Metastases Sanjiv S. Agarwala, MD Professor of Medicine Temple University School of Medicine Chief, Oncology & Hematology St. Luke s Cancer Center, Bethlehem, PA, USA Incidence (US):
More informationDr. Sause: Clinical, Research, and Administration. Vilija N. Avizonis, MD Radiation Oncologist; Intermountain Medical Center; Murray, Utah
Dr. Sause: Clinical, Research, and Administration Vilija N. Avizonis, MD Radiation Oncologist; Intermountain Medical Center; Murray, Utah Objectives: Identify Dr. Sause's educational achievements Discuss
More informationPREHYDRATION: 1000 ml NS with potassium chloride 20 meq and magnesium sulphate 2 g IV over 1 hour prior to CISplatin
BC Cancer Protocol Summary for Treatment of Newly Diagnosed Nasal, Extranodal Natural Killer (NK) or T-cell lymphoma, using Concurrent Radiation and weekly CISplatin followed by Etoposide, Ifosfamide,
More informationRadio-chemo-immunotherapy using the IDO-inhibitor indoximod for children with progressive brain tumors in the phase 1 setting (NCT )
Radio-chemo-immunotherapy using the IDO-inhibitor indoximod for children with progressive brain tumors in the phase 1 setting (NCT02502708) Theodore S. Johnson, M.D., Ph.D. Pediatric Immunotherapy Program
More informationThe Clinical Research E-News
Volume 3: ISSUE 11: June 15, 2011 The Clinical Research E-News Reminder: CRA Quarterly Meeting, Philadelphia, PA: 10-11am on Wednesday June 22nd- Virtual Meeting: dial information attached in a separate
More informationPanitumumab After Resection of Liver Metastases From Colorectal Cancer in KRAS Wild-type Patients
1 von 5 23.11.2011 10:52 Home Search Study Topics Glossary Full Text View Tabular View No Study Results Posted Related Studies Panitumumab After Resection of Liver Metastases From Colorectal Cancer in
More informationORIGINAL ARTICLE CHEMOTHERAPY ALONE FOR ORGAN PRESERVATION IN ADVANCED LARYNGEAL CANCER
ORIGINAL ARTICLE CHEMOTHERAPY ALONE FOR ORGAN PRESERVATION IN ADVANCED LARYNGEAL CANCER Vasu Divi, MD, 1 * Francis P. Worden, MD, 1,2 * Mark E. Prince, MD, 1 Avraham Eisbruch, MD, 3 Julia S. Lee, MD, 4
More informationNSABP PROTOCOL B-34. Date Opened to Randomization: December 1, 2000 Date Closed to Randomization: March 31, 2004 Number of Patients Randomized: 3,323
NSABP PROTOCOL B-34 A Clinical Trial Comparing Adjuvant Clodronate Therapy versus Placebo in Early-Stage Breast Cancer Patients Receiving Systemic Chemotherapy and/or Tamoxifen or No Therapy Date Opened
More informationBC Cancer Protocol Summary for Therapy of Acute Myeloid Leukemia Using azacitidine and SORAfenib
BC Cancer Protocol Summary for Therapy of Acute Myeloid Leukemia Using azacitidine and SORAfenib Protocol Code Tumour Group Contact Physician ULKAMLAS Leukemia/BMT Dr. Donna Hogge ELIGIBILITY: Acute myeloid
More informationComparison of Three Radiation Dose Levels after EBVP Regimen in Favorable Supradiaphragmatic Clinical Stages I-II Hodgkin s Lymphoma (HL):
Comparison of Three Radiation Dose Levels after EBVP Regimen in Favorable Supradiaphragmatic Clinical Stages I-II Hodgkin s Lymphoma (HL): Preliminary Results of the EORTC-GELA H9-F Trial H. Eghbali, P.
More informationStudy Title The SACS trial - Phase II Study of Adjuvant Therapy in CarcinoSarcoma of the Uterus
Study Title The SACS trial - Phase II Study of Adjuvant Therapy in CarcinoSarcoma of the Uterus Investigators Dr Bronwyn King, Peter MacCallum Cancer Centre Dr Linda Mileshkin, Peter MacCallum Cancer Centre
More informationCOG-ACNS1123: Phase 2 Trial of Response-Based Radiation Therapy for Patients with Localized Central Nervous System Germ Cell Tumors (CNS GCT)
Page 1 of 6 COG-ACNS1123: Phase 2 Trial of Response-Based Radiation Therapy for Patients with Localized Central Nervous System Germ Cell Tumors (CNS GCT) FAST FACTS Eligibility Reviewed and Verified By
More informationClinical Trials in Transoral Endoscopic Head &Neck Surgery ECOG3311 and RTOG1221. Chris Holsinger, MD, FACS Bob Ferris, MD, PhD, FACS
Clinical Trials in Transoral Endoscopic Head &Neck Surgery ECOG3311 and RTOG1221 Chris Holsinger, MD, FACS Bob Ferris, MD, PhD, FACS 1 Disclosure I have no conflicts of interest to disclose 2 Robotic H&N
More informationPhase II study of carboplatin (CBDCA) in progressive low-grade gliomas
Neurosurg Focus 4 (4):Article 3, 1998 Phase II study of carboplatin (CBDCA) in progressive low-grade gliomas Albert Moghrabi, M.D., Henry S. Friedman, M.D., David M. Ashley, M.B.B.S., Ph.D., Krystal S.
More informationThe Clinical Research E-News
The Clinical Research E-News Volume 7: ISSUE 1: January 16, 2015 Jefferson Kimmel Cancer Center Network: For urgent clinical trial questions or assistance please page: 877-656-9004 New Featured Trials
More informationNON-SURGICAL STRATEGY FOR ADULT EPENDYMOMA
NON-SURGICAL STRATEGY FOR ADULT EPENDYMOMA Roberta Rudà Department of Neuro-Oncology University and City of Health and Science Hospital of Turin, Italy EORTC EANO ESMO Conference 2015 Istanbul, March 27-28
More informationTemozolomide with Radiotherapy for the Treatment of Malignant Gliomas, Center Experience
Temozolomide with Radiotherapy for the Treatment of Malignant Gliomas, Center Experience *Ehab Abdou and **Mohamed Gaafar *Department of Radiation Oncology, Faculty of Medicine, Al-Azhar University, Cairo,
More informationBRLAACDT. Protocol Code. Breast. Tumour Group. Dr. Karen Gelmon. Contact Physician
BCCA Protocol Summary for Treatment of Locally Advanced Breast Cancer using DOXOrubicin and Cyclophosphamide followed by DOCEtaxel and Trastuzumab (HERCEPTIN) Protocol Code Tumour Group Contact Physician
More informationSystemic Treatment. Third International Neuro-Oncology Course. 23 May 2014
Low-Grade Astrocytoma of the CNS: Systemic Treatment Third International Neuro-Oncology Course São Paulo, Brazil 23 May 2014 John de Groot, MD Associate Professor, Neuro-Oncology UT MD Anderson Cancer
More informationRTOG Lung Cancer Committee 2012 Clinical Trial Update. Wally Curran RTOG Group Chairman
RTOG Lung Cancer Committee 2012 Clinical Trial Update Wally Curran RTOG Group Chairman 1 RTOG Lung Committee: Active Trials Small Cell Lung Cancer Limited Stage (Intergroup Trial) Extensive Stage (RTOG
More informationIntra-arterial Targeted Delivery of Gemcitabine in Treatment of Patients with Loco-regional Pancreatic Tumors
Intra-arterial Targeted Delivery of Gemcitabine in Treatment of Patients with Loco-regional Pancreatic Tumors Alexander Rosemurgy, M.D., Sharona Ross, M.D., Paul Vitulli, M.D., Florida Hospital Tampa,
More informationFAST FACTS Eligibility Reviewed and Verified By MD/DO/RN/LPN/CRA Date MD/DO/RN/LPN/CRA Date Consent Version Dated
Page 1 of 5 COG-AEWS1221: Randomized Phase 3 Trial Evaluating the Addition of the IGF-1R Monoclonal Antibody Ganitumab (AMG 479, NSC# 750008, IND# 120449) to Multiagent Chemotherapy for Patients with Newly
More informationDistal Pancreatectomy with Celiac Axis Resection: What Are the Added Risks?
Distal Pancreatectomy with Celiac Axis Resection: What Are the Added Risks? Joal D. Beane, MD a, Michael G. House, MD a, Susan C. Pitt, MD c, E. Molly Kilbane a, Bruce L. Hall c, Abishek Parmar d, Taylor.
More informationProtocol Abstract and Schema
Protocol Abstract and Schema A Molecular Biology and Phase II Study of Imetelstat (GRN163L) in Children with Recurrent High-Grade Glioma, Ependymoma, Medulloblastoma/Primitive Neuroectodermal Tumor and
More informationPrior to 1993, the only data available in the medical
Neuro-Oncology Prospective clinical trials of intracranial low-grade glioma in adults and children Edward G. Shaw 1 and Jeffrey H. Wisoff Department of Radiation Oncology, Wake Forest University School
More informationSetting The setting was secondary care. The economic study was carried out in the UK.
Cost-utility analysis of the GC versus MVAC regimens for the treatment of locally advanced or metastatic bladder cancer Robinson P, von der Masse H, Bhalla S, Kielhorn A, Aristides M, Brown A, Tilden D
More informationPBTC-045: Abstract and Schema
PBTC-045: A Safety and Preliminary Efficacy trial of MK-3475 (pembrolizumab; anti-pd-1) in Children with recurrent, progressive or refractory high-grade gliomas (HGG) and DIPGs Abstract and Schema This
More informationPRINCESS MARGARET CANCER CENTRE CLINICAL PRACTICE GUIDELINES
PRINCESS MARGARET CANCER CENTRE CLINICAL PRACTICE GUIDELINES CENTRAL NERVOUS SYSTEM ANAPLASTIC GLIOMAS CNS Site Group Anaplastic Gliomas Author: Dr. Norm Laperriere Date: February 20, 2018 1. INTRODUCTION
More informationPREMEDICATIONS: Antiemetic protocol for highly emetogenic chemotherapy. May not need any antiemetic with
BCCA Protocol Summary for Palliative Therapy of Metastatic or Locally Advanced Gastric, Gastroesophageal Junction Adenocarcinoma, Esophageal Squamous Cell Carcinoma, or Anal Squamous Cell Carcinoma using
More informationSAFETY CONSIDERATIONS WITH YONDELIS (trabectedin)
SAFETY CONSIDERATIONS WITH YONDELIS (trabectedin) Please see Important Safety Information on pages 14 and 15 and accompanying full Prescribing Information. YONDELIS (trabectedin) STUDY DESIGN INDICATION
More informationScottish Medicines Consortium
Scottish Medicines Consortium temozolomide 5, 20, 100 and 250mg capsules (Temodal ) Schering Plough UK Ltd No. (244/06) New indication: for the treatment of newly diagnosed glioblastoma multiforme concomitantly
More information