Trial · NCT00009737

A Study of Xeloda (Capecitabine) Compared With 5-Fluorouracil in Combination With Low-Dose Leucovorin in Patients Who Have Undergone Surgery for Colon Cancer

NCT00009737, Phase 3, Completed, Hoffmann-La Roche; results first posted 2016-06-22

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. A Study of Xeloda (Capecitabine) Compared With 5-Fluorouracil in Combination With Low-Dose Leucovorin in Patients Who Have Undergone Surgery for Colon Cancer. Trials, record NCT00009737. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00009737

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Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title: A Study of Xeloda (Capecitabine) Compared With 5-Fluorouracil in Combination With Low-Dose Leucovorin in Patients Who Have Undergone Surgery for Colon Cancer
NCT number: NCT00009737
Status: Completed
Phases: Phase 3
Enrollment: 1,987 participants, actual
Lead sponsor: Hoffmann-La Roche
Conditions: Colorectal Cancer
Interventions: 5-Fluorouracil, Leucovorin, Capecitabine [Xeloda]
First posted: 2004-03-17
Last updated: 2016-06-22
Results first posted: 2016-06-22

Source ClinicalTrials.gov

Registered outcomes6

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

List	Outcome	Time frame	Description
Primary	Disease-free Survival	Approximately 3 years	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).
Secondary	Relapse-Free Survival	Approximately 3 years	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.
Secondary	Overall Survival	Approximately 3 years	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).
Secondary	Mean Change From Baseline in Global Health Status at Week 25	Baseline (Days -7 to 1) and at Week 25	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.
Secondary	Number of Participants With Abnormalities for Blood Chemistry and Hematological Parameters	Up to Week 25	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.
Secondary	Number of Participants With Any Adverse Events and Serious Adverse Events	Up to Week 29	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.

Source ClinicalTrials.gov

Outcomes6

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Disease-free Survival	Approximately 3 years	All randomized population included all participants who were randomized to one of the two treatment arms, regardless of whether they received any study medication.	Participants	NUMBER
SECONDARY	Relapse-Free Survival	Approximately 3 years	All randomized population included all participants who were randomized to one of the two treatment arms, regardless of whether they received any study medication.	Participants	NUMBER
SECONDARY	Overall Survival	Approximately 3 years	All randomized population included all participants who were randomized to one of the two treatment arms, regardless of whether they received any study medication.	Participants	NUMBER
SECONDARY	Mean Change From Baseline in Global Health Status at Week 25	Baseline (Days -7 to 1) and at Week 25	The safety population included all participants who received at least one dose of capecitabine, 5-fluorouracil, or leucovorin and had at least one post baseline safety assessment (adverse events, laboratory test results, or vital signs).	Score on a scale	MEAN
SECONDARY	Number of Participants With Abnormalities for Blood Chemistry and Hematological Parameters	Up to Week 25	The safety population comprises all participants who received at least one dose of capecitabine, 5-fluorouracil, or leucovorin and had at least one post baseline safety assessment.	Participants	NUMBER
SECONDARY	Number of Participants With Any Adverse Events and Serious Adverse Events	Up to Week 29	The safety population comprises all participants who received at least one dose of capecitabine, 5-fluorouracil, or leucovorin and had at least one post baseline safety assessment	Participants	NUMBER

Source ClinicalTrials.gov

Results by group44

Each measurement the trial posted, group by group, in the words and numbers it posted.

Outcome	Group	Category	Value	Spread	Units
Disease-free Survival	Capecitabine		656		Participants
Disease-free Survival	5-Fluorouracil + Leucovorin		603		Participants
Relapse-Free Survival	Capecitabine		677		Participants
Relapse-Free Survival	5-Fluorouracil + Leucovorin		621		Participants
Overall Survival	Capecitabine		804		Participants
Overall Survival	5-Fluorouracil + Leucovorin		756		Participants
Mean Change From Baseline in Global Health Status at Week 25	Capecitabine		2.1	Standard Error 0.80	Score on a scale
Mean Change From Baseline in Global Health Status at Week 25	5-Fluorouracil + Leucovorin		2.6	Standard Error 0.78	Score on a scale
Number of Participants With Abnormalities for Blood Chemistry and Hematological Parameters	Capecitabine	Alanine transaminase	327		Participants
Number of Participants With Abnormalities for Blood Chemistry and Hematological Parameters	5-Fluorouracil + Leucovorin	Alanine transaminase	333		Participants

1 to 10 of 44Source ClinicalTrials.gov

See all 44 results by group

Participant flow6

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants
Overall Study	STARTED	Capecitabine	1,004
Overall Study	STARTED	5-Fluorouracil + Leucovorin	983
Overall Study	COMPLETED	Capecitabine	834
Overall Study	COMPLETED	5-Fluorouracil + Leucovorin	860
Overall Study	NOT COMPLETED	Capecitabine	170
Overall Study	NOT COMPLETED	5-Fluorouracil + Leucovorin	123

Source ClinicalTrials.gov

Adverse events408

Each adverse event the trial posted, group by group: the participants affected out of those at risk.

Type	Event	Organ system	Group	Affected	At risk
other	Diarrhoea	Gastrointestinal disorders	Capecitabine	437	995
other	Diarrhoea	Gastrointestinal disorders	5-Fluorouracil + Leucovorin	610	974
other	Nausea	Gastrointestinal disorders	Capecitabine	334	995
other	Nausea	Gastrointestinal disorders	5-Fluorouracil + Leucovorin	459	974
other	Stomatitis all	Gastrointestinal disorders	Capecitabine	218	995
other	Stomatitis all	Gastrointestinal disorders	5-Fluorouracil + Leucovorin	574	974
other	Vomiting	Gastrointestinal disorders	Capecitabine	147	995
other	Vomiting	Gastrointestinal disorders	5-Fluorouracil + Leucovorin	199	974
other	Abdominal pain	Gastrointestinal disorders	Capecitabine	133	995
other	Abdominal pain	Gastrointestinal disorders	5-Fluorouracil + Leucovorin	149	974

1 to 10 of 408Source ClinicalTrials.gov

See all 408 adverse events

Adverse event totals6

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Capecitabine
Total, all-cause mortality	5-Fluorouracil + Leucovorin
Total, other adverse events	Capecitabine	838	995
Total, other adverse events	5-Fluorouracil + Leucovorin	847	974
Total, serious adverse events	Capecitabine	181	995
Total, serious adverse events	5-Fluorouracil + Leucovorin	182	974

Source ClinicalTrials.gov

Papers0

The papers the trial lists on ClinicalTrials.gov.

None in this release.

Grants0

The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.

None in this release.

Trial comparisons4

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

Comparison	Source
Capecitabine vs 5-Fluorouracil + Leucovorin: Relapse-Free Survival	Trial comparisons
Capecitabine vs 5-Fluorouracil + Leucovorin: Disease-free Survival	Trial comparisons
Capecitabine vs 5-Fluorouracil + Leucovorin: Overall Survival	Trial comparisons
Capecitabine vs 5-Fluorouracil + Leucovorin: serious adverse events	Trial comparisons

Tests0

The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.

None in this release.

Data dates

The day each source was copied for this release.

ClinicalTrials.gov: 2026-11-12; ClinicalTrials.gov
Results, from AACT: 2026-03-23; AACT
NIH grant links: 2026-11-13; NIH RePORTER

Sources 3

ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
ClinicalTrials.govNo license stated
NIH RePORTER's clinical studies and project filesPublic domain

Each source's terms

ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
ClinicalTrials.govnone stated
NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

For software

Read this trial from software.

The record and each of its lists are JSON, twenty rows a page. No key.

GET https://conductscience.org/api/trials/v1/NCT00009737

GET https://conductscience.org/api/trials/v1/NCT00009737/results?page=2

API reference For AI assistants