A Study of Capecitabine (Xeloda) in the Adjuvant Treatment of Participants With Resected Colon Cancer

Roche

Status and phase: Completed; Phase 4

Conditions: Colorectal Cancer

Treatments: Drug: Capecitabine

Study type: Interventional

Funder types: Industry

Identifiers

NCT02581423

ML18601

Details and patient eligibility

About

This study will evaluate the safety and tolerability of capecitabine (Xeloda) in participants who have undergone surgery for colon cancer. Oral Xeloda will be administered twice daily in 3-week cycles for a total of up to 8 cycles. The anticipated time on study treatment is 24 weeks, and the target sample size is 70 individuals.

Enrollment: 63 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Adults at least 18 years of age
• Curative surgery for Stage III colon cancer, performed 4 to 8 weeks before study entry

Exclusion criteria

• Macroscopic or microscopic residual tumor
• Evidence of metastatic disease including tumor cells in ascites
• Previous cytotoxic chemotherapy, radiotherapy, or immunotherapy for colon cancer
• Active cardiovascular disease
• Other malignancy within the last 5 years, other than curatively treated basal cell cancer of the skin or in situ cancer of the cervix
• Malabsorption syndrome or lack of physical integrity of the upper gastrointestinal tract

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

---

63 participants in 1 patient group

Capecitabine

Experimental group

Description:

Participants will receive capecitabine for up to approximately 6 months.

Treatment:

Drug: Capecitabine