Phase 3
Completed N=1,886
A Study of Xeloda (Capecitabine) Plus Oxaliplatin in Patients With Colon Cancer
Source: ClinicalTrials.gov NCT00069121 ↗Enrolled (actual)
1,886
Serious AEs
23.1%
Results posted
Jul 2011
Primary outcomePrimary: Disease-Free Survival (DFS) [Number of Events] — 379; 320; 563; 624 Participants
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Disease-Free Survival (DFS) [Number of Events] |
379; 320; 563; 624 | — |
| PRIMARY Disease-Free Survival (DFS) [Time to Event] |
NA; 88.6 | 0.0038 sig |
| SECONDARY Relapse-Free Survival (RFS) [Number of Events] |
356; 290; 586; 654 | — |
| SECONDARY Relapse-Free Survival (RFS) [Time to Event] |
NA; 88.6 | 0.0015 sig |
| SECONDARY Overall Survival [Number of Events] |
286; 242; 656; 702 | — |
| SECONDARY Overall Survival [Time to Event] |
NA; NA | 0.0367 sig |
| SECONDARY Number of Participants With at Least One Adverse Event by Most Severe Intensity |
557; 256; 855; 493; 217; 792 | — |
Eligibility Criteria
Inclusion Criteria
- Histologically confirmed colon carcinoma, AJCC/UICC Stage III (Dukes stage C)
- Complete tumor resection; Patients operated with curative intent and with no macroscopic or microscopic evidence for remaining tumor who can be randomized to either treatment arm within 8 weeks after surgery. As this is an adjuvant trial patients should never have had any evidence of metastatic disease (including presence of tumor cells in the ascites).
- Have a life expectancy of at least 5 years
Exclusion Criteria
- Pregnant or lactating women
- Sexually active males and females (of childbearing potential) unwilling to practice contraception during the study
- Previous cytotoxic chemotherapy, radiotherapy or immunotherapy, for the currently treated colon cancer
- Patients who have not completely recovered from surgery
Data sourced from ClinicalTrials.gov (NCT00069121). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.