Trial · NCT00002525

Perioperative Chemotherapy in Treating Patients With Colon Cancer That Can Be Surgically Removed

NCT00002525, Phase 3, Terminated, ECOG-ACRIN Cancer Research Group; results first posted 2016-07-20

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. Perioperative Chemotherapy in Treating Patients With Colon Cancer That Can Be Surgically Removed. Trials, record NCT00002525. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00002525

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Trial

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

Title: Perioperative Chemotherapy in Treating Patients With Colon Cancer That Can Be Surgically Removed
NCT number: NCT00002525
Status: Terminated
Phases: Phase 3
Enrollment: 859 participants, actual
Lead sponsor: ECOG-ACRIN Cancer Research Group
Conditions: Colorectal Cancer
Interventions: fluorouracil, leucovorin calcium
First posted: 2004-04-06
Last updated: 2023-06-28
Results first posted: 2016-07-20

Source ClinicalTrials.gov

Registered outcomes4

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

List	Outcome	Time frame	Description
Primary	5-year Overall Survival Rate in Patients With Dukes' B3/C Disease	every 3 months for 2 years, then every 6 months for 2 years, and then annually until year 15 after randomization	Overall survival (OS) is defined as time from randomization to death from any cause or last date known alive. Kaplan-Meier method was used to estimate 5-year OS rate
Secondary	5-year Disease-free Survival Rate in Patients With Dukes' B3/C Disease	every 3 months for 2 years, then every 6 months for 2 years, and then annually until year 15 after randomization	Disease-free survival (DFS) was defined as time from randomization to recurrence, second invasive primary cancer, or deaths, whichever occurred first. Patients who were still alive and had no DFS events were censored at the last disease assessment date known to be free of DFS events. Patients without any follow up data were censored at random assignment. Kaplan-Meier method was used to estimate the 5-year DFS rate.
Secondary	5-year Overall Survival Rate in Patients With Dukes' B2 Disease	every 3 months for 2 years, then every 6 months for 2 years, and then annually until year 15 after randomization	Overall survival (OS) is defined as time from randomization to death from any cause or last date known alive. Kaplan-Meier method was used to estimate 5-year OS rate
Secondary	5-year Disease-free Survival Rate in Patients With Dukes' B2 Disease	every 3 months for 2 years, then every 6 months for 2 years, and then annually until year 15 after randomization	Disease-free survival (DFS) was defined as time from randomization to recurrence, second invasive primary cancer, or deaths, whichever occurred first. Patients who were still alive and had no DFS events were censored at the last disease assessment date known to be free of DFS events. Patients without any follow up data were censored at random assignment. Kaplan-Meier method was used to estimate the 5-year DFS rate.

Source ClinicalTrials.gov

Outcomes4

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

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	5-year Overall Survival Rate in Patients With Dukes' B3/C Disease	every 3 months for 2 years, then every 6 months for 2 years, and then annually until year 15 after randomization	All randomized patients with Dukes' B3 and C disease	proportion of participants	NUMBER
SECONDARY	5-year Disease-free Survival Rate in Patients With Dukes' B3/C Disease	every 3 months for 2 years, then every 6 months for 2 years, and then annually until year 15 after randomization	All randomized patients with Dukes' B3 and C disease who had complete disease assessment data	proportion of participants	NUMBER
SECONDARY	5-year Overall Survival Rate in Patients With Dukes' B2 Disease	every 3 months for 2 years, then every 6 months for 2 years, and then annually until year 15 after randomization	All randomized patients with Dukes' B2 disease	proportion of participants	NUMBER
SECONDARY	5-year Disease-free Survival Rate in Patients With Dukes' B2 Disease	every 3 months for 2 years, then every 6 months for 2 years, and then annually until year 15 after randomization	All randomized patients with Dukes' B2 disease who had complete disease assessment data	proportion of participants	NUMBER

Source ClinicalTrials.gov

Results by group8

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

Outcome	Group	Value	Spread	Units
5-year Overall Survival Rate in Patients With Dukes' B3/C Disease	Perioperative 5-FU	0.666	95% Confidence Interval 0.585 to 0.735	proportion of participants
5-year Overall Survival Rate in Patients With Dukes' B3/C Disease	No Perioperative 5-FU	0.612	95% Confidence Interval 0.530 to 0.683	proportion of participants
5-year Disease-free Survival Rate in Patients With Dukes' B3/C Disease	Perioperative 5-FU	0.582	95% Confidence Interval 0.486 to 0.668	proportion of participants
5-year Disease-free Survival Rate in Patients With Dukes' B3/C Disease	No Perioperative 5-FU	0.543	95% Confidence Interval 0.442 to 0.634	proportion of participants
5-year Overall Survival Rate in Patients With Dukes' B2 Disease	Perioperative 5-FU	0.851	95% Confidence Interval 0.783 to 0.899	proportion of participants
5-year Overall Survival Rate in Patients With Dukes' B2 Disease	No Perioperative 5-FU	0.780	95% Confidence Interval 0.701 to 0.841	proportion of participants
5-year Disease-free Survival Rate in Patients With Dukes' B2 Disease	Perioperative 5-FU	0.749	95% Confidence Interval 0.660 to 0.818	proportion of participants
5-year Disease-free Survival Rate in Patients With Dukes' B2 Disease	No Perioperative 5-FU	0.724	95% Confidence Interval 0.626 to 0.801	proportion of participants

Source ClinicalTrials.gov

Participant flow12

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

Period	Milestone	Group	Participants
Overall Study	STARTED	Perioperative 5-FU	427
Overall Study	STARTED	No Perioperative 5-FU	428
Overall Study	Treated	Perioperative 5-FU	419
Overall Study	Treated	No Perioperative 5-FU	0
Overall Study	Dukes' B3 or C Stage	Perioperative 5-FU	156
Overall Study	Dukes' B3 or C Stage	No Perioperative 5-FU	158
Overall Study	Dukes' B2 Stage	Perioperative 5-FU	150
Overall Study	Dukes' B2 Stage	No Perioperative 5-FU	139
Overall Study	COMPLETED	Perioperative 5-FU	241
Overall Study	COMPLETED	No Perioperative 5-FU	428

1 to 10 of 12Source ClinicalTrials.gov

See all 12 participant flow

Adverse events132

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	Leukopenia	Investigations	Arm I (Perioperative 5-FU)	25	418
other	Leukopenia	Investigations	Arm II (No Perioperative 5-FU)	2	422
other	Leukopenia	Investigations	Adjuvant Chemotherapy-- 5-FU+Levamisolem	78	171
other	Leukopenia	Investigations	Adjuvant Chemotherapy-- 5-FU+Leucovovin	32	61
other	Thrombocytopenia	Investigations	Arm I (Perioperative 5-FU)	24	418
other	Thrombocytopenia	Investigations	Arm II (No Perioperative 5-FU)	0	422
other	Thrombocytopenia	Investigations	Adjuvant Chemotherapy-- 5-FU+Levamisolem	66	171
other	Thrombocytopenia	Investigations	Adjuvant Chemotherapy-- 5-FU+Leucovovin	14	61
other	Anemia	Blood and lymphatic system disorders	Arm I (Perioperative 5-FU)	209	418
other	Anemia	Blood and lymphatic system disorders	Arm II (No Perioperative 5-FU)	7	422

1 to 10 of 132Source ClinicalTrials.gov

See all 132 adverse events

Adverse event totals12

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Arm I (Perioperative 5-FU)
Total, all-cause mortality	Arm II (No Perioperative 5-FU)
Total, all-cause mortality	Adjuvant Chemotherapy-- 5-FU+Levamisolem
Total, all-cause mortality	Adjuvant Chemotherapy-- 5-FU+Leucovovin
Total, other adverse events	Arm I (Perioperative 5-FU)	236	418
Total, other adverse events	Arm II (No Perioperative 5-FU)	9	422
Total, other adverse events	Adjuvant Chemotherapy-- 5-FU+Levamisolem	167	171
Total, other adverse events	Adjuvant Chemotherapy-- 5-FU+Leucovovin	58	61
Total, serious adverse events	Arm I (Perioperative 5-FU)	75	418
Total, serious adverse events	Arm II (No Perioperative 5-FU)	4	422

1 to 10 of 12Source ClinicalTrials.gov

See all 12 adverse event totals

Papers0

The papers the trial lists on ClinicalTrials.gov.

None in this release.

Grants1

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.

Project	Title	Principal investigators	Organization	Funder	Fiscal years
U10CA023318	ECOG Statistical Office	GRAY, ROBERT J	DANA-FARBER CANCER INST	NATIONAL CANCER INSTITUTE	1985 to 2013

Source NIH RePORTER

Trial comparisons0

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

None in this release.

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/NCT00002525

GET https://conductscience.org/api/trials/v1/NCT00002525/events?page=2

API reference For AI assistants