The IDEA (International Duration Evaluation of Adjuvant Chemotherapy) Collaboration: Prospective Combined Analysis of Phase III Trials Investigating Duration of Adjuvant Therapy with the FOLFOX (FOLFOX4 or Modified FOLFOX6) or XELOX (3 versus 6 months) Regimen for Patients with Stage III Colon Cancer: Trial Design and Current Status

Abstract

The International Duration Evaluation of Adjuvant Chemotherapy (IDEA) collaboration was established to prospectively combine and analyze data from several randomized trials conducted around the world to answer whether a three-month course of oxaliplatin-based adjuvant therapy (FOLFOX4/modified FOLFOX6 or XELOX) is non-inferior to the current standard six-month treatment for patients with stage III colon cancer, with a primary endpoint of three years disease-free survival. The IDEA steering committee comprises two members from each group coordinating an individual trial and two members from a secretariat who coordinate combining of the data and management of the joint analysis. Members of the IDEA agreed to combine the data from their individual trials to enable definitive analysis consisting of at least 10,500 patients. With accrual of 8,797 patients at the end of February 2013, the IDEA is on track to achieve its accrual objective of at least 10,500 patients by the end of 2013.

Keywords: 5-Fluorouracil; Adjuvants pharmaceutic; Capecitabine; Chemotherapy; Colon cancer; Colonic neoplasms; Duration of therapy; Fluoropyrimidines; International collaboration; Leucovorin; Neuropathy; Oxaliplatin; Phase III; Stage III.

Conflict of interest statement

Thierry André has received compensation from Roche and Sanofi for service as a consultant, and payment for lectures including service on speakers bureaus from Roche. Timothy Iveson has received compensation from Roche for service as a consultant and payment for lectures including service on speakers bureaus, and has received reimbursement from Roche, Amgen, and Sanofi for travel to conferences. Roberto Labianca, Jeffrey A. Meyerhardt, and Ioannis Souglakos declare that they have no conflict of interest. Takayuki Yoshino has received a consulting fee/honorarium from Chugai and Yakult; has received compensation from Takeda for service as a consultant; is supported by grants from Daiichi Sankyo, Taiho, Bayer, and ImClone; has received payment for lectures including service on speakers bureaus from Chugai, Yakult, Bristol-Myers Squibb, and Merck Serono. James Paul is supported by a grant from the National Institute for Health Research (NIHR)/Medical Research Council (MRC) EMR Programme. Alberto Sobrero has received compensation from Sanofi, Amgen, Bayer, and Roche for service as a board member and a consultant. Julien Taieb has received compensation from Roche, Merck, and Sanofi for service as a board member and payment for lectures including service on speakers bureaus, and is supported by grants from Roche, Merck, and Sanofi. Anthony F. Shields is supported by a grant from Southwest Oncology Group (SWOG)/National Cancer Institute (NCI) (Grant #U10 CA032102). Atsushi Ohtsu declares that he has no conflict of interest. Axel Grothey has received a consulting fee/honorarium from Sanofi, and has received compensation from Genentech, Bayer, and Amgen for service as a consultant. Daniel J. Sargent is supported by a grant from the Mayo Clinic.