Dutch Colorectal Cancer Group Newsletter September

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1 CONTENTS Introduction page 1 News page 2 Corporate Support page 3 ASPIRIN trial page 4 CAIRO5 page 5 CAIRO6 page 6 COLLISION page 7 FIT page 8 ORCHESTRA page 9 PLCRC page 10 STAR-TREC page 11 RAPIDO page 12 COLOFON BOARD DCCG: Dr. P.J. Tanis, Surgical Oncology, chairman Prof.dr. M. Koopman, Medical Oncology, secretary Dr. J. Buijsen, treasurer, Radiotherapy Prof.dr. G.A. Meijer, Pathology Prof.dr. R.G.H. Beets-Tan, Radiology Prof. R.H. Sijmons, Clinical Genetics Mrs. F. Barbieri, finance manager Mrs. M. Schnater, office management Introduction The DCCG started 2017 with several new ideas and initiatives. The DCCG has the intention to become the central coordinating and facilitating organization for multicenter colorectal cancer research in the Netherlands. Colorectal cancer is one of the most prevalent cancers, every hospital is dealing with these patients to some extent, and treatment has a multidisciplinary character with several involved disciplines. This is the reason that there is an extensive number of research activities nationwide. The DCCG has a reputation of coordinating several successful trials, such as the TME and CAIRO trials. It is our goal to build further on these achievements by cooperating with all researchers and relevant organizations throughout the country in the field of colorectal cancer. The DCCG board members have been replaced almost completely during the last two years. This requires a lot of input from all new members, but also provides opportunities to build a new future. One of the structural changes is the formation of four working groups that will coordinate the research activities within specific areas, namely screening and early diagnosis, primary tumour, local treatment of metastastic disease and systemic therapy. Chairman s have been appointed for each working group, and they are currently recruiting motivated researchers from relevant disciplines. On the 6 th of July, we had a very successful DCCG research meeting. Every working group invited research coordinators and principle investigators to give a short talk on ongoing trials or new proposals. It was a rather busy program, but we managed to provide a broad overview of ongoing trials and other research activities, with lively discussions among the participants. This resulted in several suggestions for improving the study design or accrual, for specific data analyses, and led to potential new cooperations between researchers. One of the highlights at the end of the meeting was the announcement by the former DCCG chairman, Kees Punt, about the financial support by KWF of the Dutch Oncology Research Platform (DORP), which will be set up in the coming months to support multicenter trials in all organizational aspects. The DCCG research meeting is intended to become a biannual meeting, and the next meeting is scheduled for the 14 th of December. We hope that this will become another great meeting. We are also working on the 9 th EMCCC, which we are planning to organize in Lisbon in March 2019 in cooperation with some other European CRC research groups. We are pleased to update you on the current activities of the DCCG with an update of ongoing trials by means of this newsletter. Informing everybody involved in all ongoing CRC trials is an important aspect of trial management for updating and continuous awareness of relevant trials that need sufficient accrual. However, everybody s boxes are overcrowded. This is why we propose as DCCG to also coordinate trial newsletters, by collecting all updates from DCCG trials every 3 months that will subsequently be send as a DCCG newsletter four times a year. Hopefully, this newsletter will be the start of a joined regular update of DCCG trials and research activities. Dr. Pieter Tanis, chairman DCCG Dutch Colorectal Cancer Group Newsletter September

2 NEWS Save the date: second DCCG afternoon: December, 14th 2017 EMCCC 2019 Portugal 5D congress: February 8 and 9, 2018 DORP More trials of better quality that are timely completed with more patients: the Dutch Oncology Research Platform (DORP) has received funding by KWF! Complex legislation and lack of uniformity in procedures between hospitals increasingly hamper the conduct of clinical investigator-initiated cancer research, in a time when financial budgets for clinical research is limited and more trials are needed with innovative designs due to the fact that subgroups of patients are identified by clinical and molecular parameters which require individual treatments. As a consequence, the number of trials as well as the number of patients participating to trials decline. This has a negative influence on the development of new therapeutic options for patients and discredits the excellent reputation of The Netherlands on clinical cancer research. In order to solve this very relevant problem, the Dutch Colorectal Cancer Group (DCCG), Borstkanker Onderzoek Groep (BOOG), Stichting Hematologie-Oncologie voor Volwassenen Nederland (HOVON), Integraal Kanker Centrum Nederland (IKNL) and the department of Biostatistics of the Netherlands Cancer Institute (NKI) have joined forces to develop the Dutch Oncology Research Platform (DORP): a national infrastructure that should facilitate clinical cancer research. Initially the focus is on investigator-initiated multicenter research. DORP aims to support clinical cancer researchers in the development of trials protocols and, once financial support has been obtained, the initiation and conduct of the trial in participating centers. This is being done by newly appointed DORP staff (to start with statisticians, monitors and project managers) who will be seconded to departments/institutions with specific expertise on that topic, and who will operate under supervision of a DORP director. So this is how it should work in practice: a researcher or research group has defined a research question that should be addressed within the scope of a clinical trial; DORP supports the development of a full protocol including statistics which meets all requirements for external funding; once funding has been obtained, DORP supports submission to ethics committee, local approval and implementation in participating hospitals, monitoring, financial management and other administration. In addition, DORP statisticians will initiate novel and innovative trial designs that should accommodate prospective research in subgroups in which classic phase 3 studies are less feasible, and will also support in extracting more data from completed trials (i.e. subgroup analyses, meta-analyses, etc.). Of note, DORP will not interfere with the scientific content of the study, since this remains the responsibility of the principal investigator/research group. The mission of DORP is more trials of better quality that are timely completed with more patients. The DORP project has been very well received in The Netherlands by all cancer research groups, large datacenters, patient organizations (NFK), hospital organizations (NVZ/STZ, NFU), professional organizations (SONCOS), Ministry of Health (VWS), research support organizations (DCRF), and funding organizations (KWF, ZonMw). We are very pleased to announce that the Dutch Cancer Foundation KWF has recently decided to provide financial support to DORP for a period of 4 years. Currently the appointment of a DORP director is in progress, and all stakeholders will be informed within the coming months about procedures. We are very much looking forward to put this ambitious project in motion! Prof.dr. Kees Punt, chairman of DORP Dutch Colorectal Cancer Group Newsletter September

3 Corporate Support DCCG corporate activities are funded with corporate sponsorship. The corporate sponsors provide general support and have no influence on activities or policy of the DCCG. DCCG is pleased to acknowledge the corporate support of: Platinum corporate sponsors Secretariat Monique Schnater P/A IKNL Godebaldkwartier DT Utrecht, The Netherlands Tel: E: W: This newsletter can be downloaded from the DCCG website. Bronze corporate sponsor Dutch Colorectal Cancer Group Newsletter September

4 A Phase III double-blind placebo-controlled Randomised Trial of Aspirin on Recurrence and Survival in Colon Cancer Patients Therapy To study the effect of 80mg acetylsalicylic acid (given orally once daily for 5 years) for stage II and III colon cancer patients of 45 years and older. Patients will be stratified according to age (<70 years and 70 years), stage, chemotherapy use (any versus none) and center. The question will be addressed by means of two parallel studies in patients treated with or without adjuvant chemotherapy patients are needed. The ASPIRIN trial is open for inclusion. There are 34 participating centers in the Netherlands of which 28 are currently including. The Belgium part of the trial just got approval and we expect to open the trial in another 12 hospitals in the near future. New centers are still welcome! Until august 2017, 239 of the 1588 necessary patients are included. Please contact the Datacenter for more information or visit the website of the Aspirin Trialist Collaborative Group: Participating centers: Arm A: 80 mg Aspirin Arm B: Placebo Planned patient accrual: 1588 patients Actual accrual: 239 patients (August 2017) Primary endpoint 5 year overall survival (OS) Principal investigators Dr. G.J. Liefers Dept. Surgical Oncology, LUMC Leiden Prof. Dr. J.E.A. Portielje Dept. Medical Oncology, LUMC Leiden Prof. Dr. R. Fodde Dept. Pathology, Erasmus MC Rotterdam Central data and trial management Ir. E. Meershoek-Klein Kranenbarg Ing. J.P.B.M. Braak Datacenter Department of Surgery, LUMC Leiden Datacenter@lumc.nl or ALMELO [Ziekenhuisgroep Twente] HAARLEM [Spaarne Gasthuis] AMERSFOORT [Meander MC] HARDERWIJK [St. Jansdal] AMSTERDAM [OLVG] HELMOND [Elkerrliek Zkh] ASSEN [Wilhelmina Ziekenhuis] HOOFDDORP [Spaarne Gasthuis] BREDA [Amphia Ziekenhuis] LEIDEN [LUMC] CAPELLE A/D IJSSEL [IJsselland Ziekenhuis] LEIDERDORP [Alrijne,Leiderdorp] DELFT [RdGG] LEIDSCHENDAM (Antoniushove] DEN HAAG [HaGaZiekenhuis] LELYSTAD [MC Zuidezee] DEVENTER [Deventer Ziekenhuis] NIEUWEGEIN [St. Antonius] DOETINCHEM [Slingeland Ziekenhuis] ROTTERDAM [Ikazia zkh] DRACHTEN [Ziekenhuis Nij Smellinghe] SCHIEDAM [Vlietland zkh] EDE [Ziekenhuis Gelderse Vallei] SNEEK [Antonius ziekenhuis] EINDHOVEN [Catharina Ziekenhuis] TERNEUZEN [Zorgsaam Z. Vl] EINDHOVEN [Maxima MC] TILBURG [Elisabeth Tweesteden] ENSCHEDE [MST] VENLO [viecuri MC] GOES [ADRZ] WINTERSWIJK [SKB] GORINCHEM [Beatrix Ziekenhuis] ZOETERMEER [Lange land] Dutch Colorectal Cancer Group Newsletter September

5 CAIRO5 Treatment strategies in colorectal cancer patients with initially unresetable liver-only metastases. A Randomised Phase 3 Study. Randomisation RAS/BRAF mutation and/or right-sided tumor: Arm A: FOLFOX/FOLFIRI + bevacizumab Arm B: FOLFOXIRI + bevacizumab RAS/BRAF wildtype and left-sided tumor: Arm C: FOLFOX/FOLFIRI + bevacizumab Arm D: FOLFOX/FOLFIRI + panitumumab Planned patient accrual 564 Primary endpoint Median progression-free survival (PFS) Study coordinator Karen Bolhuis, Dept. Medical Oncology AMC E: k.bolhuis@amc.nl, T: Principal investigators Prof. dr. Kees Punt, Dept. Medical Oncology AMC Prof. dr. Thomas van Gulik, Dept. Surgery AMC Data management IKNL clinical research department; E: trialbureau@iknl.nl; T: Study design This month we were happy to welcome the 55 th hospital participating in the CAIRO5 study. CAIRO5 started recruiting patients in 2014 and by now 175 patients have been enrolled in the study. The liver expert panel, a unique collaboration of 12 experienced liver surgeons and 5 radiologists, has reviewed over 330 scans for resectability. Recently an amendment to the study protocol has been submitted concerning patients eligible for anti-egfr therapy. Studies demonstrated the relevance of primary tumor localization in RAS and BRAF wildtype metastatic colorectal cancer patients. Patients with right-sided primary tumors do not benefit from anti-egfr therapy. Therefore, only patients with RAS and BRAF wildtype AND left-sided primary tumors are eligible for randomization to the study arm in which chemotherapy plus bevacizumab is compared with chemotherapy plus panitumumab Finally we ask your attention to the fact that ALL patients with initially unresectable liver-only metastases are eligible for study participation. This includes patients with permanently unresectable metastases. Also, patients with non-specified pulmonary nodules of < 1 cm on CT scan are eligible. Lastly, patients with their primary tumor still in situ are eligible, provided that this tumor is considered resectable in case downsizing has permitted radical local treatment of livermetastases. Dutch Colorectal Cancer Group Newsletter September

6 CAIRO6 Perioperative systemic therapy and surgery versus upfront surgery alone for resectable colorectal peritoneal metastases: a randomised controlled study. Flowchart Planned patient accrual 358 Actual patient accrual 4 Primary endpoint 3-year overall survival Study coordinator Drs. K.P.B. Rovers; Department of Surgery, Catharina Hospital, Eindhoven; E: koen.rovers@catharinaziekenhuis.nl; T: Principal Investigators - Dr. I.H.J.T. de Hingh; Department of Surgery, Catharina Hospital, Eindhoven; E: ignace.d.hingh@catharinaziekenhuis.nl; - Dr. P.J. Tanis; Department of Surgery, Academic Medical Centre, Amsterdam; E: p.j.tanis@amc.uva.nl; - Prof. dr. C.J.A. Punt; Department of Medical Oncology, Academic Medical Centre, Amsterdam; E: c.punt@amc.uva.nl; Central Data Management Drs. J.M. Bouma; Netherlands Comprehensive Cancer Organisation, Utrecht; E: j.bouma@iknl.nl; In July 2017, the CAIRO6 study has started accrual in the Catharina Hospital, Eindhoven. Ever since, the study has been, or will be, initiated in the following HIPEC centres: St. Antonius Hospital, Nieuwegein: July 2017 VU University Medical Centre, Amsterdam: July 2017 University Medical Centre Groningen, Groningen: July 2017 Radboud University Medical Centre, Nijmegen: July 2017 University Medical Centre Utrecht, Utrecht: July 2017 Erasmus University Medical Centre, Rotterdam: August 2017 Netherlands Cancer Institute, Amsterdam: September 2017 Medisch Spectrum Twente, Enschede: January 2018 With an estimated accrual of 10 patients per HIPEC centre per year, the study team expects to recruit the planned 80 patients of the randomised phase II part of the study before September The primary objective of the phase II study is to analyse the safety of the patients in the experimental arm, which is assessed by comparing both arms with regard to major postoperative morbidity and the number of patients who undergo surgery. If the experimental treatment has shown to be safe, this study proceeds as a randomised phase III study with an additional accrual of 278 patients in 3 years. Blood and tissue samples are regularly collected and processed in both arms at prespecified time points, and stored at -20 C/-80 C for translational research. The study team considers this translational research component as an important additive to the clinical part of the study. Lastly, the study team would like to thank: All members of the Dutch Colorectal Cancer Group (DCCG) and the Dutch Peritoneal Oncology Group (DPOG) for the scientific support of this study; All surgeons, medical oncologists, pathologists, research nurses, physician assistants, and PhD students of the participating HIPEC centres for their important work that they have already performed; The Netherlands Comprehensive Cancer Organisation for their relevant support in preparing, conducting, and monitoring this study; The Dutch Cancer Society, Roche, Netherlands Cancer Institute, and the Catharina Hospital for the financial support of this study; The research groups of R. Fijneman (Netherlands Cancer Institute) and O. Kranenburg (UMC Utrecht) for their initiatives in setting up the translational research component. Thank you all! The CAIRO6 study team Website Dutch Colorectal Cancer Group Newsletter September

7 COLLISION Colorectal liver metastases: surgery versus thermal ablation a phase III, single-blind, multicenter, non-inferiority, prospective randomized controlled trial Therapy To prove non-inferiority of thermal ablation compared to surgical resection in patients with at least one resectable and ablatable colorectal liver metastasis (CRLM) of 3cm and no extrahepatic disease. Arm A (n=309): surgical resection Arm B (n=309): thermal ablation Planned patient accrual: 687 Primary endpoint: overall survival (OS; intentionto-treat analysis). The COLLISION trial has been approved by the Ethics Committee of the VUmc. Currently the trial is being submitted by several hospitals for local feasibility. Three centers are ready to start recruiting and we expect this number to grow in the near future. VUmc is expected to start treating the first patient in the beginning of September We would like to thank all participating centers in advance. Anyone who is interested in the study or who would like to participate, please contact the study coordinator. Centers currently allowed to participate: Maastricht Universitair Medisch Centrum, Maastricht VU Universitair Medisch Centrum, Amsterdam Ziekenhuis Gelderse Vallei, Ede Centers with approval by EC of VUmc and waiting for local feasibility: Antoni van Leeuwenhoek Ziekenhuis, Amsterdam Leids Universitair Medisch Centrum, Leiden Radboud Universitair Medisch Centrum, Nijmegen Participation not yet formally approved by EC of VUmc Academisch Medisch Centrum Amsterdam, Amsterdam Medisch Centrum Leeuwarden, Leeuwarden Onze Lieve Vrouwe Gasthuis, Amsterdam Principal investigators M.R. Meijerink, MD, PhD Dept Interventional Radiology, VUmc Amsterdam M.P. van den Tol, MD, PhD Dept Surgical Oncology, VUmc Amsterdam Study coordinator R.S. Puijk, MD Dept Interventional Radiology, VUmc Amsterdam E: r.puijk@vumc.nl Research assistant C.L. (Laura) van Dam, Msc. P: E: c.vandam1@vumc.nl Research nurse N. (Natasha) Sorgedrager, Msc. P: E: n.sorgedrager@vumc.nl Central and local data management Clinical Research Bureau VUmc, Amsterdam I. Joore, Msc. J.G.M. Stolwijk, Msc. Website: Dutch Colorectal Cancer Group Newsletter September

8 FIT-trial Multicentre randomized controlled trial comparing ferric(iii) carboxymaltose infusion with oral iron supplementation in the treatment of preoperative anaemia in colorectal cancer patients Arm A: Intravenous ferric(iii)carboxymaltose Arm B: 3x200mg Ferrofumarate daily Planned patient accrual: 198 patients Primary endpoint: Percentage of patients with normalization of Hblevel. Will be measured at the day of admission before surgery. Which is one day prior to surgery. The Hb-level will be followed-up after surgery on postoperative day 1, day 7 and after 4,8 and 12 weeks The study is gradually including patients thanks to all participating centers. Current inclusion amount: 115/198 patients. We welcomed Gelderse Vallei as a new hospital this year and hope to inititiate Amstelland Ziekenhuis shortly. We will put all our efforts to help you to gather the last inclusions the coming year in order to provide some definitive answers regarding preoperative iron supplementation in patients with colorectal cancer. Study coordinator E.R.J. Bruns Dept Colorectal Surgery, AMC Amsterdam e.r.bruns@amc.nl Principal investigators Prof Dr W.A. Bemelman Dept Surgery, AMC Amsterdam Dutch Colorectal Cancer Group Newsletter September

9 A randomized multicenter clinical trial for patients with multi-organ, Colorectal cancer metastases comparing the combination of CHEmotherapy and maximal tumor debulking versus chemotherapy Alone Therapy All participants receive first line palliative systemic therapy (CAPOX or FOLFOX ± bevacizumab). After 3 or 4 cycles, patients with response or stable disease are randomized. Arm A: continuation of systemic therapy Arm B: maximal tumor debulking, followed by continuation of systemic therapy Planned patient accrual: 478 Actual patient accrual: 170 Primary endpoint: Overall Survival benefit of >6 months Study coordinator/ Central datamanagement Elske Gootjes, dept of Med.Oncology, VUmc Tel: , orchestra@vumc.nl Local Datamanagement: IKNL in participating centers as requested. Principal investigators Prof. dr. Henk Verheul, Dept of Med. Oncology VUmc Prof. dr. Kees Verhoef, Dept of Surg. Oncology, EMC Main inclusion criteria Patients with multi-organ mcrc with an indication for first line palliative chemotherapy with CRC metastases in 2 organs - if >1 extrahepatic metastases or - including >5 hepatic metastases not located to one lobe or - including either a positive para-aortal /celiac lymph nodes, adrenal metastases or peritoneal/pleural carcinomatosis Tumor debulking (at least 80%) is deemed feasible by an expert panel. For tumor debulking, local treatment modalities may include surgery, radiofrequency ablation (RFA), transarterial chemoembolization (TACE) or stereotactic ablative radiotherapy (SABR). For patients that are eligible for both ORCHESTRA and CAIRO4, inclusion in CAIRO4 has priority. Background Adding local treatment of metastases to standard systemic chemotherapy is a novel concept in palliative treatment of patients with multi-organ metastatic colorectal cancer (mcrc). Current palliative treatment consists of systemic therapy. Selected patients with multi organ mcrc have been shown to benefit from local treatment of metastases. We hypothesize that maximal tumor debulking will improve survival of patients with multi-organ mcrc and therefore have designed this randomized multi center clinical trial aimed to definitely answer this question After inclusion of the first 100 patients, debulking in the ORCHESTRA trial demonstrated to be feasible and safe and does not prohibit administration of palliative chemotherapy in the majority of patients with multi-organ mcrc. (Presented at ASCO J Clin Oncol 35, 2017 (suppl; abstr 3553) Currently 170 patients are included. The trial will continue accrual to determine whether the aim of > 6 months OS benefit from tumor debulking will be achieved. Participating centers and all relevant documentation is available at the DCCG website. Dutch Colorectal Cancer Group Newsletter September

10 PLCRC PLCRC, Prospective Dutch Colorectal Cancer Cohort, is a population-based observational cohort study for all Dutch patients diagnosed with colorectal cancer. Aim is to establish a continuous source for a large variety of research purposes. Currently more than 15 studies make use of the infrastructure. For this project, prospectively collected clinical data are requested from the Netherlands Cancer Registry. Participating patients will also be invited to complete questionnaires on selfreported Health Related Quality of Life (HRQoL) and work ability, and to donate blood and tumor tissue samples for future research purposes. This cohort of colorectal cancer patients provides an infrastructure for research and can be used for studies, for example studies to evaluate the impact of diet and lifestyle on treatment response, or to evaluate new treatment modalities according to the cohort multiple randomized controlled trial design. Number of patients In September 2017, over 1900 patients are included. There are 32 participating centers and another 20 centers are in the process of obtaining METC approval. Several substudies are ongoing, including (additional information: - MEDOCC: Prospective observational cohort study to evaluate the prognostic relevance of ctdna in stage II CRC - ORCA: Observational study to explore changes in RAS mutation status in ctdna in patients with RASwt non-liver limited mcrc over time - PROTECT: Observational study to evaluate the impact of diet and lifestyle on treatment response. - PROTECT+: Observational study to examine the association of (changes in) body composition and grade II-IV treatment toxicities of adjuvant systemic therapy in patients with stage IIb/III colon cancer. - QUALITAS: Study to evaluate the quality of life of mcrc patients treated with trifluridineti (TAS-102). Program manager Dr. G.R. Vink g.vink@iknl.nl PLCRC Study team info@plcrc.nl Dutch Colorectal Cancer Group Newsletter September

11 STAR-TREC Can we Save the rectum by Watchful waiting or TransAnal microsurgery following (chemo)radiotherapy versus Total mesorectal excision for early Rectal Cancer? A multicentre international randomized, 3 armparallel, phase II feasibility study in patients with biopsy proven rectal cancer. Intervention Arm A: Standard TME surgery Arm B: 5x5Gy followed by watchful waiting Arm C: 25x2Gy and capecitabine followed by watchful waiting Planned patient accrual: >=4 patients per month in year 1 internationally (NL + Denmark + UK) >=6 patients per month in year 2 (total of 120 patients internationally) Actual patient accrual in the Netherlands: 1 This phase II feasibility study has recently included the first patient. The STAR-TREC trial is an international, randomized controlled trial between the United Kingdom, Denmark and the Netherlands. Patients with ct1-3b rectal cancer will be randomized to either standard TME surgery (control), organ saving treatment using long course concurrent chemoradiation, or organ saving treatment using short course radiotherapy. The primary endpoint of this phase II study is to demonstrate sufficient international recruitment in order to sustain a phase III study incorporating pelvic failure as the primary endpoint. The first patient has recently been randomized at the Radboudumc. The Isala hospital is also open for inclusion and several other centers will start inclusion soon. Participating centers Radboudumc AvL VUmc Ijsselland Laurentius MC Leeuwarden Radiation therapy centers Not applicable (NA) NA NA Erasmus MC, Daniel den Hoed MAASTRO RIF Primary endpoint: reaching the target for patient recruitment Principal investigator: prof. dr. J.H.W. de Wilt Study coordinator: drs. A.J.M. Rombouts Tel: star-trec@radboudumc.nl Central data management: Integraal kankercentrum Nederland (IKNL) Tel: trialbureau@iknl.nl Catharina Amphia Elisabeth-Twee Steden Leiden UMC Isala Diakonessenhuis NA Bernard Verbeeten Bernard Verbeeten NA NA UMC Utrecht Dutch Colorectal Cancer Group Newsletter September

12 RAPIDO Rectal cancer And Pre operative Induction therapy followed by Dedicated Operation Randomized multicenter phase III study of short course radiation therapy followed by prolonged preoperative chemotherapy and surgery in patients with high risk primary rectal cancer compared to standard preoperative chemoradiotherapy and surgery and optional adjuvant chemotherapy. Therapy Arm A: standard: long course chemoradiation (28 x 1,8Gy or 25 x 2Gy) followed by TME surgery and optional postoperative chemotherapy Arm B: experimental: short course 5 x 5 Gy radiation followed by six cycles of CAPOX and TME surgery Planned patient accrual: 920 Actual patient accrual: 920 Primary endpoints Time to disease related treatment failure (TdrTF) after 3 years follow-up Principal investigators Dr. Boudewijn van Etten, UMCG B.van.Etten@chir.umcg.nl Prof. Dr. Geke Hospers, UMCG G.A.P.Hospers@int.umcg.nl Prof. Dr. Corrie Marijnen, LUMC marijnen@lumc.nl Prof. Dr. Cornelis van de Velde, LUMC C.J.H.van_de_Velde@lumc.nl Central data management Drs. Annet Roodvoets & Ir. Elma Meershoek, Leiden University Medical Center Datacenter Surgery, K6-R PO Box 9600, 2300 RC LEIDEN, The Netherlands Phone: , Fax: datacenter@lumc.nl Website: Patients from 54 centers in 7 countries were randomized in the RAPIDO study. June 2016 the RAPIDO trial was closed for inclusion. During the past year the RAPIDO trial has been discussed at several national and international congresses: ECC10, ECCO17, Therapie op Maat, ESTRO36 and ACPGBI2017. Short term conclusions were: In the experimental arm ~80% received 6 cycles of CAP(OX) SAEs in pre-operative phase: 14% of patients in standard arm vs 28% of patients in the experimental arm Pre- and post-operative mortality < 1% in both arms Radical resection: ~86% pcr: ~20% Interim analysis The first (blinded) interim analysis at 226 TtdrTF events is expected to be performed during this Autumn. Quality of life Long term side effects after radiation and rectal surgery are known to have great impact on patient s quality of life. Patients eligible (alive and disease free) receive questionnaires on Quality of life and LARS 3 years after surgery. We are now working hard to process all the gathered data and we appreciate your ongoing support in completing follow-up, sending QoL and LARS questionnaires and finalizing study data. Thank you! Top 10 including centers in the RAPIDO 1 Akademiska Sjukhuset, Uppsala, SE Karolinska Institutet, Stockholm, SE 71 3 Amphia Ziekenhuis, Breda, NL 51 4 Hosp. Val d Hebron, Barcelona, ES 39 5 NWZ Alkmaar, NL 36 6 Onkološki Inštitut, LJjubljana, SL 16 7 Linköpings Universitet, SE 30 8 MC Leeuwarden, NL 28 9 Hospital Clinico Valencia, ES UMCG Groningen, NL 23 Dutch Colorectal Cancer Group Newsletter September