• NSABP C07
    Share

Trial Status

Completed

Cancer Type

Colorectal Cancer

Protocol Title

A clinical trial comparing 5-fluorouracil (5-FU) plus leucovorin (LV) and oxaliplatin with 5-FU plus LV for the treatment of patients with stages II and III carcinoma of the colon.

Purpose of the Study

Adjuvant chemotherapy with 5-FU and LV given after surgery improves recurrence and cure rates for people with early colon cancer.  Oxaliplatin is a chemotherapy drug that can help people with advanced colon cancer.  This study determined if adding oxaliplatin to standard treatment can also help people with early colon cancer.

Principal Investigator

Prof Michael Findlay

Funding

National Surgical Adjuvant Breast and Bowel Project Inc. (USA), Sanofi-Aventis Inc. (USA) and Sanofi-Aventis Australia P/L

DETAILED INFORMATION AVAILABLE

Available online at ClinicalTrials.Gov, please click here

Trial Status

Completed

Cancer Type

Colorectal Cancer

Publication Reference

  1. Yothers G, O’Connell M, Allegra C, Kuebler J, Colangelo L, Petrelli N, Wolmark N. Oxaliplatin as adjuvant therapy for colon cancer: updated results of NSABP C-07 trial, including survival and subset analyses. Journal of Clinical Oncology 2011; 29(28): 3768-3774.
  2. Kuebler JP, Colangelo L, O’Connell MJ, Smith RE, Yothers G, Begovic M, Robinson B, Seay TE, Wolmark N. Severe enteropathy among patients with stage II/III colon cancer treated on a randomized trial of bolus 5-fluorouracil/leucovorin plus or minus oxaliplatin: a prospective analysis. Cancer 2007; 110(9): 1945–1950.
  3. Kuebler JP, Wieand S, O’Connell MJ, et al. Oxaliplatin combined with weekly bolus fluorouracil and leucovorin as surgical adjuvant chemotherapy for stage II and III colon cancer: results from NSABP C-07. Journal of Clinical Oncology 2007; 25(16): 2198–2204.
  4. Land SR, Kopec JA, Cecchini RS, Ganz PA, Wieand HS, Colangelo LH, Murphy K, Kuebler JP, Seay TE, Needles BM, Bearden JD 3rd, Colman LK, Lanier KS, Pajon ER Jr, Cella D, Smith RE, O’Connell MJ, Costantino JP, Wolmark N. Neurotoxicity from oxaliplatin combined with weekly bolus fluorouracil and leucovorin as surgical adjuvant chemotherapy for stage II and III colon cancer: NSABP C-07. Journal of Clinical Oncology 2007; 25(16): 2205–2211.

Conference Presentation Reference

  1. Marks P, Dhillon H, Simes J, for the Australasian Gastro-Intestinal Trials Group and NHMRC Clinical Trials Centre. Screening logs for improving recruitment to the NSABP C-07 trial. Clinical Oncological Society of Australia Annual Scientific Meeting; 28-30 November 2001; Brisbane.
  2. O’Connell M, Lee M, Lopatin M, Yothers G, Clark-Langone K, Millward C, Pail S, Sharif S, Shak S, Wolmark N. Validation of the 12-gene colon cancer recurrence score in NSABP C07 as a predictor of recurrence in stage II and III colon cancer patients treated with 5FU/LV and 5FU/LV+oxaliplatin. American Society of Clinical Oncology Annual Meeting; 1–5 Jun 2012; Chicago. Abstract 3512 .

Aim

The primary aim of this study is to compare the relative efficacy of 5-FU + LV + Oxaliplatin (FLOX) with that of 5-FU + LV (FL) in prolonging Disease Free Survival. The secondary aim of the study is to compare the relative efficacy of FLOX with that of FL in prolonging Survival.

Principal Investigator

Michael Findlay

Funding

National Surgical Adjuvant Breast and Bowel Project Inc. (USA), Sanofi-Aventis Inc. (USA) and Sanofi-Aventis Australia P/L