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IDEA Update International Duration Evaluation of Adjuvant Chemotherapy (IDEA) Colon Cancer Prospective Pooled Analysis A newsletter for IDEA investigators May 2015 Collaboration Update IDEA colleagues, as we enter 2015, the IDEA group continues to make substantial progress. Two trials remain open, the CALGB/SWOG trial and the HORG trial, and both should complete accrual by the end of 2015. In January 2015 the number of events were updated. Thanks to all investigators and statisticians for providing this information. The good news is that overall the number of events is tracking very closely to projections. There is slight heterogeneity by study, but since formal data sweeps have not been conducted, uniformly among trials is likely a differential delay in reporting between studies. Thanks to the efforts of the Steering Committee, and particularly Lindsay Renfro, Ph.D., at the Mayo Clinic research base, a paper was recently published providing details on the modeling process for estimating the number of events over time, and thus the timing of the final IDEA analysis. Based on the projections, and the January event count, (which will be updated every 6 months) we remain on target for a final IDEA analysis in the second half of 2016. While enrollment to IDEA studies is winding down, continued vigilant follow-up and data collection for all trials remains critical. We know that the colon cancer research and patient communities worldwide are eagerly awaiting our results, which we wish to provide as soon as possible. Efforts will be initiated in late 2015 or early 2016 to facilitate rapid data collection and analysis once the number of events required for analysis has been observed. Thus, we continue to have good progress on the IDEA project. Thank you for all of your contributions to IDEA. IDEA Steering Committee: Timothy Iveson, M.D., principal investigator (P.I.), Short Course Oncology Treatment (SCOT) trial; Jim Paul, M.S., SCOT trial; Roberto Labianca, M.D., co-P.I., Three or Six Colon Adjuvant (TOSCA) trial; Alberto Sobrero, M.D., co-P.I., TOSCA trial; Jeffrey Meyerhardt, M.D., M.P.H., Cancer and Leukemia Group B (CALGB) chair, C80702 trial; Anthony Shields, M.D., Ph.D., P.I., Southwest Oncology Group (SWOG), C80702 trial; Thierry André, M.D., co-P.I., PRODIGE-Groupe Coopérateur Multidisciplinaire en Oncologie (GERCOR) trial; Julien Taieb, M.D., co-P.I., PRODIGE-GERCOR trial; Atsushi Ohtsu, M.D., co-P. I., ACHIEVE trial; Takayuki Yoshino, M.D., co-P.I., ACHIEVE trial; Ioannis Souglakos, M.D., P.I., Hellenic Oncology Research Group (HORG); Axel Grothey, M.D., North Central Cancer Treatment Group (NCCTG) Secretariat; Daniel Sargent, Ph.D., NCCTG Secretariat. IDEA Coordination Committee: Donna Niedzwiecki, Ph.D., (CALGB); Irene Floriani, Ph.D., (TOSCA); Jim Paul, M.S., (SCOT); Frank Bonnetain, Ph.D., (PRODIGE-GERCOR); and Daniel Sargent, Ph.D., (Secretariat). Accrual Update Cancer and Leukemia Group B (CALGB)/ Southwest Oncology Group (SWOG) trial C80702 Activation date: July 2010 Current status: Open Planned accrual: 2,500 patients Sites open: 588 sites are listed in ClinicalTrials. gov – endorsed by all adult oncology treatment cooperative groups in the US and Canada Current accrual: 2,120 patients, current accrual rate is approximately 50 participants per month. HORG trial Activation date: October 2010 Current status: Open Planned accrual: 1,000 patients Sites open: 15 sites have been activated (13 have at least one patient enrolled) Current accrual: 656 patients with stage III colon cancer. Accrual rate has been slow for the past 3 months due to problems with availability of oxaliplatin. Timeline for IDEA Colon Cancer Prospective Pooled Analysis 2009 2007 • June 2007: Three or Six Colon Adjuvant (TOSCA) trial opens • May 2009: PRODIGE-Groupe Coopérateur Multidisciplinaire en Oncologie (GERCOR) trial opens 2013 2011 • November 2013: SCOT trial closes, accruing 4,018 stage III colon cancer patients 2015 2008 2010 2012 2014 2016 • March 2008: Short Course Oncology Treatment (SCOT) trial opens • July 2010: Cancer and Leukemia Group B (CALGB)/Southwest Oncology Group (SWOG) trial C80702 opens • October 2010: HORG trial opens • August 2012: Japanese Foundation for Multidisciplinary Treatment of Cancer JFMC 47-1202-C3 (ACHIEVE) trial opens • December 2012: TOSCA trial closes, accruing 2,436 stage III colon cancer patients • April 2014: PRODIGEGERCOR trial closes; accruing 2,020 stage III colon cancer patients • May 2014: interim analysis completed • June 2014: ACHIEVE trial closes; accruing 1,313 stage III colon cancer patients •September 2016: Projected final analysis IDEA Overview The purpose of International Duration Evaluation of Adjuvant Chemotherapy (IDEA) is to facilitate the collaboration among multiple individual trials conducted around the world for a single, pooled analysis of the primary aim: To test whether 3 months of oxaliplatin-based adjuvant therapy is non-inferior for disease-free survival (DFS) to 6 months of the identical therapy in patients with stage III colon cancer. The IDEA Steering Committee is comprised of 2 members from each group coordinating an individual trial, plus 2 members from a Secretariat, North Central Cancer Treatment Group (NCCTG), who are responsible for coordinating the data pooling and the joint analysis. (See list on page 1.) Individual trials included in IDEA may address additional trial-specific hypotheses in a factorial design; the analyses of these additional hypotheses will be trial-specific and not involve IDEA. The IDEA pooled analysis will consist only of stage III colon cancer patients enrolled in these trials. Only patients randomized to 3 or 6 months of a FOLFOX regimen (FOLFOX4 or mFOLFOX6) or XELOX will be included in the pooled analysis. The trials in IDEA share accrual information on an ongoing basis (at least every 6 months). The final pooled analysis will be conducted jointly by the IDEA Steering Committee, with the Secretariat and main data analysis site at Mayo Clinic/NCCTG. Members of IDEA have agreed to pool the data from their individual trials to allow a definitive analysis consisting of at least 10,500 patients, using DFS as the primary endpoint. Non-inferiority will be declared if the 2-sided 95%confidence interval for the hazard ratio comparing 3 to 6 months of therapy lies entirely below 1.12. A sample size of 10,500 patients provides 90% power, based on an expected accrual duration of 3.5 years, 3 years minimum follow-up, and an expected 3-year DFS rate in the control group of 72% to declare non-inferiority if the true hazard ratio is 1.0. Contact information For further information on IDEA, contact the IDEA Secretariat at: Mayo Clinic Cancer Center 200 First Street S.W. Rochester, Minnesota 55905 E-mail: [email protected] MC4094-01rev0515