TriangleNCT00009737 · CITED IN SOURCE DOCUMENTS
A Study of Xeloda (Capecitabine) Compared With 5-Fluorouracil in Combination With Low-Dose Leucovorin in Patients Who Have Undergone Surgery for Colon Cancer
An NCI or FDA source cites this study. A citation does not establish that it applies to an individual diagnosis.
- Phase
- PHASE3
- Status at capture
- COMPLETED
- Registry last update
- 2016-06-22
This 2 arm study will compare the safety and efficacy of oral Xeloda, or 5-fluorouracil in combination with leucovorin, in patients who have undergone surgery for colon cancer. Patients will be randomized to receive either Xeloda 1250mg/m2 po bid on days 1-14 every 21 days, or leucovorin 20mg/m2 iv + 5-fluorouracil 425mg/m2 iv daily from day 1 to day 5 every 28 days. The anticipated time on study treatment is 3-12 months, and the target sample size is 500+ individuals.
Open the original ClinicalTrials.gov record → · Download preserved record
What did the study report?
Outcomes, safety and baseline populations are separate source sections. Quality-of-life measures appear under their original outcome titles.
Participant flow
Baseline characteristics
Disease-free Survival
Relapse-Free Survival
Overall Survival
Mean Change From Baseline in Global Health Status at Week 25
Number of Participants With Abnormalities for Blood Chemistry and Hematological Parameters
Number of Participants With Any Adverse Events and Serious Adverse Events
Adverse events
Limitations, agreements, and source contact
Who could take part
- eligibility Criteria
- Inclusion Criteria: * adult patients 18-75 years of age; * histologically confirmed colon cancer with potentially curative resection of the tumor within 8 weeks before study initiation. Exclusion Criteria: * previous chemotherapy
- healthy Volunteers
- false
- maximum Age
- 75 Years
- minimum Age
- 18 Years
- sex
- ALL
- std Ages
- ADULT
- OLDER_ADULT
Treatment arms and interventions
- arm Groups
- description
- Participants received capecitabine 1250 milligram per square meter (mg/m \^ 2) orally, twice a day, for 14 days, followed by a 7-day rest period without treatment, as an intermittent therapy in a 3-week cycle for 8 cycles (24 weeks).
- intervention Names
- Drug: Capecitabine [Xeloda]
- label
- Capecitabine
- type
- EXPERIMENTAL
- description
- Participants received leucovorin 20 mg/m \^ 2 followed by 5-fluorouracil at 425 mg/m \^ 2, by rapid intravenous injection, daily, from Days 1 to 5 of the first week in each 4-week cycle for 6 cycles (24 weeks).
- intervention Names
- Drug: 5-Fluorouracil
- Drug: Leucovorin
- label
- 5-Fluorouracil + Leucovorin
- type
- ACTIVE_COMPARATOR
- interventions
- arm Group Labels
- 5-Fluorouracil + Leucovorin
- description
- 425mg/m2 iv daily from day 1 to day 5 every 28 days.
- name
- 5-Fluorouracil
- type
- DRUG
- arm Group Labels
- 5-Fluorouracil + Leucovorin
- description
- 20mg/m2 iv daily from day 1 to day 5 every 28 days.
- name
- Leucovorin
- type
- DRUG
- arm Group Labels
- Capecitabine
- description
- 1250mg/m2 po bid on days 1-14 every 21 days.
- name
- Capecitabine [Xeloda]
- type
- DRUG
Study design
- allocation
- RANDOMIZED
- intervention Model
- PARALLEL
- masking Info
- masking
- NONE
- primary Purpose
- TREATMENT
Enrollment
- count
- 1987
- type
- ACTUAL
Registered outcome plans (not posted results)
- primary Outcomes
- description
- Participants with disease-free survival were reported. Disease-free survival was assessed as the number of days between randomization and the first time at which relapse, a new occurrence of colon cancer, or death was recorded, or the last time at which a participant was known to be disease free (censoring time).
- measure
- Disease-free Survival
- time Frame
- Approximately 3 years
- secondary Outcomes
- description
- Participants with relapse-free survival were reported. Relapse-free survival was assessed as the number of days between randomization and the first time at which relapse, a new occurrence of colon cancer, or death was recorded, or the last time at which a participants was known to be disease free (censoring time), excluding deaths that were not related to treatment or to disease progression.
- measure
- Relapse-Free Survival
- time Frame
- Approximately 3 years
- description
- Participants with overall survival were reported. Overall survival was assessed as the number of days between randomization and death or the last time at which a participant was known to be alive (censoring time).
- measure
- Overall Survival
- time Frame
- Approximately 3 years
- description
- Global health status was assessed as a sub scale of European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-C30. It was scored on a scale of 0-100; where higher score indicates better quality of life. Wherever the scores for the participants were not available, the last value carried forward (LVCF) were used.
- measure
- Mean Change From Baseline in Global Health Status at Week 25
- time Frame
- Baseline (Days -7 to 1) and at Week 25
- description
- Laboratory abnormalities were categorized according to the National Cancer Institute of Canada Common Toxicity Criteria (NCIC - CTC) grading system (May 1991 revised) as Grade 1 (mild), Grade 2 (moderate), Grade 3 (severe) and Grade 4 (life- threatening). Participants with abnormalities in hemoglobin, granulocytes, lymphocytes, neutrophils, neutrophils/granulocytes, platelets, white blood cell, potassium, serum creatinine, sodium, total bilirubin, alanine transaminase, aspartate aminotransferase, alkaline phosphatase, calcium (hyper), and calcium (hypo) with Grades 1-4 were presented.
- measure
- Number of Participants With Abnormalities for Blood Chemistry and Hematological Parameters
- time Frame
- Up to Week 25
- description
- An Adverse Event (AE) is defined as any untoward medical occurrence in a participant or clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered to be related to the medicinal product. An Serious Adverse Events (SAEs) is any untoward medical occurrence that, at any dose, results in death, is life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, or results in a congenital anomaly/birth defect.
- measure
- Number of Participants With Any Adverse Events and Serious Adverse Events
- time Frame
- Up to Week 29
Full study description
- brief Summary
- This 2 arm study will compare the safety and efficacy of oral Xeloda, or 5-fluorouracil in combination with leucovorin, in patients who have undergone surgery for colon cancer. Patients will be randomized to receive either Xeloda 1250mg/m2 po bid on days 1-14 every 21 days, or leucovorin 20mg/m2 iv + 5-fluorouracil 425mg/m2 iv daily from day 1 to day 5 every 28 days. The anticipated time on study treatment is 3-12 months, and the target sample size is 500+ individuals.
Source references
Source notices and limitations
Discovery and provenance
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- occurrences
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- 14 CLINICAL STUDIES 14.1 Colorectal Cancer Adjuvant Treatment of Colon Cancer Single Agent The efficacy of XELODA was evaluated in X-ACT ( NCT00009737 ), a multicenter, randomized, controlled clinical trial. Eligible patients were between 18 and 75 years of age with histologically-confirmed Dukes' Stage C col
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Preserved source evidence · Not medical advice