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

被引:102
作者
Andre, Thierry [1 ]
Iveson, Timothy [2 ]
Labianca, Roberto [3 ]
Meyerhardt, Jeffrey A. [4 ]
Souglakos, Ioannis [5 ]
Yoshino, Takayuki [6 ]
Paul, James [7 ]
Sobrero, Alberto
Taieb, Julien [8 ]
Shields, Anthony F. [9 ]
Ohtsu, Atsushi [7 ]
Grothey, Axel [10 ]
Sargent, Daniel J. [10 ]
机构
[1] UPMC, Saint Antoine Hosp, Dept Med Oncol, Paris, France
[2] Univ Hosp Southampton NHS Fdn Trust, Southampton, England
[3] Ospedali Riuniti Bergamo, Oncol Unit, Bergamo, Italy
[4] Dana Farber Canc Inst, Harvard Med Sch, Boston, MA 02115 USA
[5] Univ Hosp Herakl, Dept Med Oncol, Iraklion, Greece
[6] Natl Canc Ctr Hosp East, Dept Gastrointestinal Oncol, Chiba, Japan
[7] Beatson West Scotland Canc Ctr, CTU, Glasgow, Lanark, Scotland
[8] Univ Paris 05, European Hosp Georges Pompidou, Digest Oncol Dept, Paris, France
[9] Wayne State Univ, Karmanos Canc Inst, Dept Oncol, Detroit, MI 48202 USA
[10] Mayo Clin, Rochester, MN 55902 USA
基金
英国医学研究理事会;
关键词
Colon cancer; Colonic neoplasms; Adjuvants pharmaceutic; Stage III; Chemotherapy; Fluoropyrimidines; 5-Fluorouracil; Leucovorin; Oxaliplatin; Capecitabine; Phase III; Duration of therapy; Neuropathy; International collaboration;
D O I
10.1007/s11888-013-0181-6
中图分类号
R73 [肿瘤学];
学科分类号
100214 ;
摘要
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.
引用
收藏
页码:261 / 269
页数:9
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