- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00502671
A Study of Xeloda (Capecitabine) as Adjuvant Monotherapy in Patients With Colon Cancer.
August 6, 2015 updated by: Hoffmann-La Roche
An Open Label Study to Evaluate the Safety of Xeloda as Adjuvant Monotherapy in Patients Who Have Undergone Surgery for Colon Cancer, Dukes Stage C.
This single arm study will evaluate the safety profile of Xeloda as monotherapy for adjuvant treatment of colon cancer.
All patients will receive Xeloda 1250mg/m2 p.o. twice daily as intermittent treatment (3 week cycles consisting of 2 weeks of treatment followed by 1 week without treatment).
The anticipated time on study treatment is 3-12 months, and the target sample size is 500+ individuals.
Study Overview
Study Type
Interventional
Enrollment (Actual)
228
Phase
- Phase 4
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Arkhangelsk, Russian Federation, 163045
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Astrakhan, Russian Federation, 414041
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Barnaul, Russian Federation, 656049
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Belgorod, Russian Federation, 308010
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Chelyabinsk, Russian Federation, 454047
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Ekaterinburg, Russian Federation, 620905
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Irkutsk, Russian Federation, 664035
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Izhevsk, Russian Federation, 426009
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Kaluga, Russian Federation, 248007
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Kazan, Russian Federation, 420029
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Kazan, Russian Federation, 420111
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Kirov, Russian Federation, 610021
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Kostroma, Russian Federation, 156005
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Krasnodar, Russian Federation, 350040
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Kursk, Russian Federation, 305035
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Lipetsk, Russian Federation, 398005
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Moscow, Russian Federation, 105229
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Moscow, Russian Federation, 107005
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Moscow, Russian Federation, 119992
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Moscow, Russian Federation, 123354
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Moscow, Russian Federation, 127006
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Moscow, Russian Federation, 143420
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Nizhny Novgorod, Russian Federation, 603126
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Novgorod Veliky, Russian Federation, 173016
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Obninsk, Russian Federation, 249036
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Orenburg, Russian Federation, 460021
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Perm, Russian Federation, 614 066
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Rostov-na-donu, Russian Federation, 344037
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Ryazan, Russian Federation, 390011
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Salekhard, Russian Federation, 629001
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Samara, Russian Federation, 443031
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Smolensk, Russian Federation, 214000
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Soshi, Russian Federation, 354057
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St Petersburg, Russian Federation, 197022
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St Petersburg, Russian Federation, 197047
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Stavropol, Russian Federation, 355047
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Surgut, Russian Federation, 628408
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Tollyatti, Russian Federation, 445846
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Tomsk, Russian Federation, 634050
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Tomsk, Russian Federation, 634028
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Tumen, Russian Federation, 625047
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Tver, Russian Federation, 170008
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UFA, Russian Federation, 450005
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UFA, Russian Federation, 450054
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Volgograd, Russian Federation, 400138
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Yuzhno-Sakhalinsk, Russian Federation, 693010
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- adult patients, >=18 years of age;
- colon cancer (Dukes stage C);
- surgery, with no evidence of remaining tumor;
- ECOG performance status of <=1.
Exclusion Criteria:
- previous therapy for currently treated colon cancer;
- any evidence of metastatic disease;
- history of other malignancy within last 5 years;
- clinically significant cardiac disease.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Non-Randomized
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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Experimental: 1
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1250mg/m2 po bid on days 1-14 of each 3 week cycle
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Percentage of Participants With an Adverse Event (AE), Serious AE, or Death Due to an AE
Time Frame: Up to 25 weeks (from Baseline to the end of safety follow-up)
|
The postmarketing safety profile of capecitabine was evaluated by collection of AEs, clinical laboratory data, vital signs, and other findings from physical examination.
Abnormalities in these findings were captured as AEs, defined as any untoward medical occurrence in a study participant regardless of the suspected cause.
Serious AEs were those which, at any dose, met one or more of the following criteria: resulted in fatality, were life-threatening, necessitated new or prolonged existing hospitalization, produced persistent or significant disability, resulted in congenital anomaly or birth defect, were considered medically significant, or required intervention to prevent any of the aforementioned outcomes.
Those specific serious AEs which resulted in fatality were also reported separately.
The percentage of participants with an AE, serious AE, or AE resulting in death was calculated as [number of participants with event divided by number analyzed] multiplied by 100.
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Up to 25 weeks (from Baseline to the end of safety follow-up)
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Percentage of Participants With Early Withdrawal or Discontinuation Due to an AE
Time Frame: Up to 25 weeks (from Baseline to the end of safety follow-up)
|
The postmarketing safety profile of capecitabine was evaluated by collection of AEs, clinical laboratory data, vital signs, and other findings from physical examination.
Abnormalities in these findings were captured as AEs, defined as any untoward medical occurrence in a study participant regardless of the suspected cause.
The percentage of participants with early withdrawal or treatment discontinuation due to an AE was calculated as [number of participants with event divided by number analyzed] multiplied by 100.
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Up to 25 weeks (from Baseline to the end of safety follow-up)
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
July 1, 2007
Primary Completion (Actual)
March 1, 2012
Study Completion (Actual)
March 1, 2012
Study Registration Dates
First Submitted
July 17, 2007
First Submitted That Met QC Criteria
July 17, 2007
First Posted (Estimate)
July 18, 2007
Study Record Updates
Last Update Posted (Estimate)
September 3, 2015
Last Update Submitted That Met QC Criteria
August 6, 2015
Last Verified
August 1, 2015
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Digestive System Diseases
- Neoplasms
- Neoplasms by Site
- Gastrointestinal Neoplasms
- Digestive System Neoplasms
- Gastrointestinal Diseases
- Colonic Diseases
- Intestinal Diseases
- Intestinal Neoplasms
- Colorectal Neoplasms
- Colonic Neoplasms
- Molecular Mechanisms of Pharmacological Action
- Antimetabolites, Antineoplastic
- Antimetabolites
- Antineoplastic Agents
- Capecitabine
Other Study ID Numbers
- ML20592
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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