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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT02581423
Recruitment Status : Completed
First Posted : October 21, 2015
Last Update Posted : November 2, 2016
Information provided by (Responsible Party):
Hoffmann-La Roche

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Colorectal Cancer Drug: Capecitabine Phase 4

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 63 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase IV Clinical Study of Safety and Tolerability of Oral Xeloda (Capecitabine) in Adjuvant Treatment of Resected Cancer of the Colon
Study Start Date : August 2005
Actual Primary Completion Date : March 2007
Actual Study Completion Date : March 2007

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: Capecitabine
Participants will receive capecitabine for up to approximately 6 months.
Drug: Capecitabine
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 Name: Xeloda

Primary Outcome Measures :
  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 Outcome Measures :
  1. Incidence of toxocity-related dose reductions [ Time Frame: Up to approximately 6 months ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT02581423

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Blagoevgrad, Bulgaria, 2700
Ruse, Bulgaria, 7000
Shumen, Bulgaria
Sofia, Bulgaria, 1431
Sofia, Bulgaria, 1527
Veliko Tarnovo, Bulgaria, 5000
Sponsors and Collaborators
Hoffmann-La Roche
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Study Chair: Clinical Trials Hoffmann-La Roche
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Responsible Party: Hoffmann-La Roche Identifier: NCT02581423    
Other Study ID Numbers: ML18601
First Posted: October 21, 2015    Key Record Dates
Last Update Posted: November 2, 2016
Last Verified: November 2016
Additional relevant MeSH terms:
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Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Colonic Diseases
Digestive System Diseases
Gastrointestinal Diseases
Intestinal Diseases
Rectal Diseases
Antimetabolites, Antineoplastic
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents