Trial Publications: CRC5, CO23 and EN7

Wednesday, February 14, 2018
CCTG trials listed in research publications or citations

Publication for CRC5 a Phase III Trial of Irinotecan/5-FU/Leucovorin or Oxaliplatin/5-FU/Leucovorin with Bevacizumab, or Cetuximab (C225), or with the Combination of Bevacizumab and Cetuximab for Patients with Untreated Metastatic Adenocarcinoma of the Colon or Rectum. The objectives of the trial is to determine if the addition of cetuximab to FOLFIRI or FOLFOX chemotherapy prolongs survival compared to FOLFIRI or FOLFOX with bevacizumab in patients with untreated, advanced or metastatic colorectal cancer who have K-ras wild type tumors.

Venook AP, Niedzwiecki D, Lenz HJ, Innocenti F, Fruth B, Meyerhardt JA, Schrag D, Greene C, O'Neil BH, Atkins JN, Berry S, Polite BN, O'Reilly EM, Goldberg RM, Hochster HS, Schilsky RL, Bertagnolli MM, El-Khoueiry AB, Watson P, Benson AB, III, Mulkerin DL, Mayer RJ, Blanke C. Effect of first-line chemotherapy combined with cetuximab or bevacizumab on overall survival in patients with kras wild-type advanced or metastatic colorectal cancer: A randomized clinical trial. J Am Med Assoc 317: 2392-401, 2017.

Publication for CO23 an overall Survival (OS) Secondary Objectives: Progression-Free Survival (PFS) -Objective Response Rate (OR) -Disease Control Rate (DCR) -Safety profile -QoL, using the EORTC QLQ-C30 -HUI3, using the HUI3 index -Comparative economic evaluation -Exposure/response relationships of BBI608 using population PK -Association between putative biomarkers in tumour/blood & clinical benefit -Establish a comprehensive tumour bank linked to a clinical database.
Jonker DJ, Nott L, Yoshino T, Gill S, Shapiro J, Ohtsu A, Zalcberg J, Vickers MM, Wei AC, Gao Y, Tebbutt NC, Markman B, Price T, Esaki T, Koski S, Hitron M, Li W, Li Y, Magoski NM, Li CJ, Simes J, Tu D, O'Callaghan CJ. Napabucasin versus placebo in refractory advanced colorectal cancer: a randomised phase 3 trial (ONLINE). The Lancet Gastroenterology & Hepatology 2018.

Publication for EN.7 a Randomized Phase III Trial Comparing Concurrent Chemoradiation and Adjuvant Chemotherapy with Pelvic Radiation Alone in High Risk and Advanced Stage Endometrial Carcinoma.
de Boer SM, Powell ME, Mileshkin L, Katsaros D, Bessette P, Haie-Meder C, Ottevanger PB, Ledermann JA, Khaw P, Colombo A, Fyles A, Baron MH, Jürgenliemk-Schulz IM, Kitchener HC, Nijman HW, Wilson G, Brooks S, Carinelli S, Provencher D, Hanzen C, Lutgens LCHW, Smit VTHB, Singh N, Do V, D'Amico R, Nout RA, Feeney A, Verhoeven-Adema KW, Putter H, Creutzberg CL. Adjuvant chemoradiotherapy versus radiotherapy alone for women with high-risk endometrial cancer (PORTEC-3): final results of an international, open-label, multicentre, randomised, phase 3 trial (ONLINE). The Lancet Oncology 2018.

For more information about study results please visit our website: As information about published study results becomes known, it will be available by searching through the utility below by protocol number, disease site or drug name.