title: 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.
authors.affiliation: Department of Medical Oncology, Saint-Antoine Hospital, and Université Pierre et Marie Curie (UPMC), Paris, France.
authors.forename: Thierry
authors.initials: T
authors.lastname: André
authors.forename: Timothy
authors.initials: T
authors.lastname: Iveson
authors.forename: Roberto
authors.initials: R
authors.lastname: Labianca
authors.forename: Jeffrey A
authors.initials: JA
authors.lastname: Meyerhardt
authors.forename: Ioannis
authors.initials: I
authors.lastname: Souglakos
authors.forename: Takayuki
authors.initials: T
authors.lastname: Yoshino
authors.forename: James
authors.initials: J
authors.lastname: Paul
authors.forename: Alberto
authors.initials: A
authors.lastname: Sobrero
authors.forename: Julien
authors.initials: J
authors.lastname: Taieb
authors.forename: Anthony F
authors.initials: AF
authors.lastname: Shields
authors.forename: Atsushi
authors.initials: A
authors.lastname: Ohtsu
authors.forename: Axel
authors.initials: A
authors.lastname: Grothey
authors.forename: Daniel J
authors.initials: DJ
authors.lastname: Sargent
keywords: 5-Fluorouracil; Adjuvants pharmaceutic; Capecitabine; Chemotherapy; Colon cancer; Colonic neoplasms; Duration of therapy; Fluoropyrimidines; International collaboration; Leucovorin; Neuropathy; Oxaliplatin; Phase III; Stage III
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