CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 1,886 enrolled
Drug / intervention
Capecitabine +3 moredrug
Likely dose
Capecitabine 1000 mg/m² orally twice daily on days 1–15 of each 3-week cycle; Oxaliplatin 130 mg/m² IV over 2 hours on day 1 of each 3-week cycleAI-extracted
Key inclusion· 4
  • ✓Histologically confirmed colon carcinoma, AJCC/UICC Stage III (Dukes stage C)
  • ✓Complete tumor resection with no macroscopic or microscopic evidence of remaining tumor; randomization within 8 weeks after surgery
  • ✓No evidence of metastatic disease or tumor cells in ascites
  • ✓Life expectancy of at least 5 years
Key exclusion· 4
  • ✕Pregnant or lactating women
  • ✕Previous cytotoxic chemotherapy, radiotherapy, or immunotherapy for the currently treated colon cancer
  • ✕Not completely recovered from surgery
  • ✕Sexually active males and females of childbearing potential unwilling to practice contraception during the study

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00069121
NCT00069121Phase 3Completed
CompareCT.gov

An Open-Label Randomized Phase III Study of Intermittent Oral Capecitabine in Combination With Intravenous Oxaliplatin (Q3W) ("XELOX") Versus Fluorouracil/Leucovorin as Adjuvant Therapy for Patients Who Have Undergone Surgery for Colon Carcinoma, AJCC/UICC Stage III (Dukes Stage C)

Hoffmann-La Roche·interventional·Posted Sep 18, 2003·Updated Mar 6, 2020

In Brief

A Phase 3 clinical trial evaluating Capecitabine, Oxaliplatin, and 2 other interventions for Colorectal Cancer. Completed, enrolled 1,886 participants across 232 sites in 29 countries.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsColorectal Cancer
CountriesAustralia, Belgium, Brazil, Canada, China, Finland, France, Germany, Greece, Hong Kong, Hungary, Ireland, Israel, Italy, Mexico, New Zealand, Panama, Poland, Portugal, Russia, Singapore, South Africa, South Korea, Spain, Switzerland, Taiwan, Thailand, United Kingdom, United States
Collaborators--

Timeline

Phase 3CompletedFinished
2003200420052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedSep 18, 2003
Enrollment StartApr 18, 2003
Primary CompletionApr 21, 2011
TodayJul 2, 2026
Enrollment to primary: 8.0 yearsPosted 22.8 years ago

Interventions

Capecitabinedrug

1000 milligrams per square metre of body surface area (mg/m\^2) orally twice daily on days 1-15 of each 3-week cycle.

Oxaliplatindrug

130 mg/m\^2 intravenous (IV) infusion over two hours on Day 1 of each 3-week cycle.

Leucovorin (LV)drug

Administered by one of two regimens, as specified in the arm description.

5-Fluorouracil (5-FU)drug

Administered by one of two regimens, as specified in the arm description.