Projecting Event-Based Analysis Dates in Clinical Trials: An Illustration Based on the International Duration Evaluation of Adjuvant Chemotherapy (IDEA) Collaboration. Projecting Analysis Dates for the IDEA Collaboration

[1] Friede T, Kieser M. Sample size recalculation in internal pilot study designs: a review. Biom J 48: 537-55, 2006Search in Google Scholar

[2] Kairalla JA, Coffey CS, Thomann MA, Muller KE. Adaptive trial designs: a review of barriers and opportunities. Trials 13:145, 2012Search in Google Scholar

[3] Bagiella E, Heitjan DF. Predicting analysis times in randomized clinical trials. Stat Med 20: 2055-63, 200110.1002/sim.84311439420Search in Google Scholar

[4] Ying G, Heitjan DF, Chen T. Nonparametric prediction of event times in randomized clinical trials. Clin Trials 1:352-261, 200410.1191/1740774504cn030oa16279273Search in Google Scholar

[5] André T, Iveson T, Labianca R, et al. for the IDEA Steering Committee. 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 Modifed FOLFOX6) or XELOX (3 versus 6 months) Regimen for Patients with Stage III Colon Cancer: Trial Design and Current Status. Curr Colorectal Cancer Rep 9: 261-9, 2013Search in Google Scholar

[6] Sargent DJ, Wieand HS, Haller DG, et al: Disease-free survival versus overall survival as a primary end point for adjuvant colon cancer studies: individual patient data from 20,898 patients on 18 randomized trials. J ClinOncol 23:8664-70, 200510.1200/JCO.2005.01.607116260700Search in Google Scholar

[7] Sargent DJ, Shi Q, Yothers G, et al: Two or three year disease free survival (DFS) as a primary endpoint in stage III adjuvant colon cancer trials with fuoropyrimidines with or without oxaliplatin or irinotecan: data from 12,676 patients from MOSAIC, X-ACT, PETACC-3, C-06, C-07, and C89803. Eur J Cancer 47:990-6, 201110.1016/j.ejca.2010.12.015307341321257306Search in Google Scholar

[8] Yothers G, O'Connell M, Allegra CJ, et al. Oxaliplatin as adjuvant therapy for colon cancer: updated results of NSABP C-07 trial, including survival and subset analyses. J ClinOncol 28: 3768-74, 2011Search in Google Scholar

[9] Allegra CJ, Yothers G, O'Connell MJ, et al. Phase III trial assessing bevacizumab in stages II and III carcinoma of the colon: results of the NSABP protocol C-08. J ClinOncol 29:11-6, 2011Search in Google Scholar

[10] Schmoll H-J, Cartwright T, Tabernero J, et al. Phase III trial of capecitabine plus oxaliplatin as adjuvant therapy for stage III colon cancer: a planned safety analysis in 1,864 patients. J ClinOncol 25:102-9, 2006Search in Google Scholar

[11] Alberts SR, Sargent DJ, Smyrk TC, et al. Adjuvant mFOLFOX6 with or without cetuximab in KRAS wild-type patients with resected stage III colon cancer: results from NCCTG intergroup phase III trial N0147. J ClinOncol 28: (18_suppl CRA3507), 2010Search in Google Scholar

[12] Kalbfeisch JD, Prentice RL. The Statistical Analysis of Failure Time Data, 2^ndedition. Hoboken, NJ: John Wiley & Sons, Inc., 2002Search in Google Scholar

[13] Prentice RL. Discrimination among some parametric models. Biometrika 62:607-614, 19710.1093/biomet/62.3.607Search in Google Scholar