A Study of Xeloda (Capecitabine) Plus Oxaliplatin in Patients With Colon Cancer
Summary
This 2 arm study will compare the efficacy and safety of intermittent oral Xeloda plus Eloxatin (oxaliplatin) with that of fluorouracil/leucovorin in patients who have had surgery for colon cancer and no previous chemotherapy. Patients will be randomized to receive either 1) XELOX (Xeloda 1000mg/m2 po bid on days 1-15 + oxaliplatin) in 3 week cycles or 2)5-fluorouracil + leucovorin in 4 or 8 week cycles. The anticipated time on study treatment is until disease progression and the target sample size is 500+ individuals.
Timeline
- Start
- 2003-04-18
- Primary completion
- 2011-04-21
- Completion
- 2011-04-21
Outcome
Met primary endpoint
registry analysis (superiority test); 5-FU/LV vs XELOX; p = 0.0038; Hazard Ratio (HR) 0.80 (95% CI 0.69 to 0.93); Log Rank; NCT00069121 ↗
paper Seven-year DFS rates were 63% and 56% in the XELOX and FU/FA groups, respectively (hazard ratio [HR], 0.80; 95% CI, 0.69 to 0.93; P = .004). PMID 26324362 ↗
Publications
- Gallois C, Shi Q, Meyers JP, Iveson T, Alberts SR, de Gramont A, Sobrero AF, Haller DG, Oki E, Shields AF, Goldberg RM, Kerr R, Lonardi S, Yothers G, Kelly C, Boukovinas I, Labianca R, Sinicrope FA, Souglakos I, Yoshino T, Meyerhardt JA, Andre T, Papamichael D, Taieb J. Prognostic Impact of Early Treatment and Oxaliplatin Discontinuation in Patients With Stage III Colon Cancer: An ACCENT/IDEA Pooled Analysis of 11 Adjuvant Trials. J Clin Oncol. 2023 Feb 1;41(4):803-815. doi: 10.1200/JCO.21.02726. Epub 2022 Oct 28.
- Schmoll HJ, Tabernero J, Maroun J, de Braud F, Price T, Van Cutsem E, Hill M, Hoersch S, Rittweger K, Haller DG. Capecitabine Plus Oxaliplatin Compared With Fluorouracil/Folinic Acid As Adjuvant Therapy for Stage III Colon Cancer: Final Results of the NO16968 Randomized Controlled Phase III Trial. J Clin Oncol. 2015 Nov 10;33(32):3733-40. doi: 10.1200/JCO.2015.60.9107. Epub 2015 Aug 31.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | 5-Fluorouracil (5-FU) | Small molecule | 425 mg/m2 | Intravenous |
| Comparator | 5-Fluorouracil (5-FU) | Small molecule | 500 mg/m2 | Intravenous |
| Subject | Capecitabine | Small molecule | 1000 mg/m2 | Oral |
| Comparator | Leucovorin (LV) | Unknown | 20 mg/m2 | Intravenous |
| Comparator | Leucovorin (LV) | Unknown | 500 mg/m2 | Intravenous |
| Subject | Oxaliplatin | Small molecule | 130 mg/m2 | Intravenous |