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Completed

NCT Number: NCT02581423

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

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.

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Key information

Conditions

Colorectal Cancer Colonic Diseases Colorectal Neoplasms Digestive System Diseases Digestive System Neoplasms Gastrointestinal Diseases Gastrointestinal Neoplasms Intestinal Diseases Intestinal Neoplasms Neoplasms Neoplasms by Site Rectal Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Blagoevgrad, Bulgaria

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Capecitabine

Drug

Participants will receive oral capecitabine, 1250 miligrams per meter-squared (mg/m^2) twice daily, in 3-week treatment cycles for up to 8 cycles. Treatment will be administered for 2 weeks followed by 1 week of rest without medication.

Other names: Xeloda

Primary outcomes

  1. Incidence of adverse events (AEs)

    Time frame: Up to approximately 6 months

  2. Incidence of treatment discontinuation due to AEs

    Time frame: Up to approximately 6 months

Secondary outcomes

  1. Incidence of toxocity-related dose reductions

    Time frame: Up to approximately 6 months

Sponsors and collaborators

Lead sponsor

Hoffmann-La Roche

Industry

Registry information

Official study title

Phase IV Clinical Study of Safety and Tolerability of Oral Xeloda (Capecitabine) in Adjuvant Treatment of Resected Cancer of the Colon

Important dates

Study start
2005
Primary completion
2007
Study completion
2007
First posted
Oct 21, 2015
Registry last updated
Nov 2, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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