Trial · NCT00068692

Comparison of Adjuvant Chemotherapy Regimens in Treating Stage II/III Rectal Cancer

NCT00068692, Phase 3, Completed, National Cancer Institute (NCI); results first posted 2018-12-04

3 sourcestrials-2026-11-12-0.5.0

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ConductScience Library. Comparison of Adjuvant Chemotherapy Regimens in Treating Stage II/III Rectal Cancer. Trials, record NCT00068692. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00068692

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Trial

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

Title: Comparison of Adjuvant Chemotherapy Regimens in Treating Stage II/III Rectal Cancer
NCT number: NCT00068692
Status: Completed
Phases: Phase 3
Enrollment: 225 participants, actual
Lead sponsor: National Cancer Institute (NCI)
Conditions: Rectal Mucinous Adenocarcinoma, Rectal Signet Ring Cell Adenocarcinoma, Recurrent Rectal Carcinoma, Stage IIA Rectal Cancer AJCC v7, Stage IIB Rectal Cancer AJCC v7, Stage IIC Rectal Cancer AJCC v7, Stage IIIA Rectal Cancer AJCC v7, Stage IIIB Rectal Cancer AJCC v7, Stage IIIC Rectal Cancer AJCC v7, Stage IVA Rectal Cancer AJCC v7, Stage IVB Rectal Cancer AJCC v7
Interventions: Radiotherapy, Fluorouracil, Leucovorin Calcium, Oxaliplatin, Irinotecan
First posted: 2003-09-11
Last updated: 2018-12-04
Results first posted: 2018-12-04

Source ClinicalTrials.gov

Registered outcomes4

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

List	Outcome	Time frame	Description
Primary	3-year Overall Survival Rate	assessed every 3 months withihn 2 years of study entry, every 6 monhts between years 3-5 and then annually for 5 years, estimated at 3 years	Overall survival (OS) was defined as time from randomization to death from any cause. 3-year OS rate was estimated using Kaplan-Meier method.
Secondary	3-year Disease Free Survival	assessed every 3 months withihn 2 years of study entry, every 6 monhts between years 3-5 and then annually for 5 years, estimated at 3 years	Disease free survival (DFS) was defined as time from randomization to recurrence, second invasive primary cancer and death from any cause, whichever occurred first. 3-year DFS rate was estimated using Kaplan-Meier method.
Secondary	Proportion of Sphincter Preservation	assessed at primary surgery time	Proportion of sphincter preservation was defined as number of patients with sphincter preservation divided by total number of patients randomized to the arm
Secondary	Failure Pattern	assessed every 3 months withihn 2 years of study entry, every 6 monhts between years 3-5 and then annually for 5 years	Type of failures (local/regional recurrence vs. distant recurrence vs. concurrent recurrence vs. second primary cancer vs. deaths) in the analysis population

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	3-year Overall Survival Rate	assessed every 3 months withihn 2 years of study entry, every 6 monhts between years 3-5 and then annually for 5 years, estimated at 3 years	All randomized patients	proportion of patients	NUMBER
SECONDARY	3-year Disease Free Survival	assessed every 3 months withihn 2 years of study entry, every 6 monhts between years 3-5 and then annually for 5 years, estimated at 3 years	All randomized patients	proportion of patients	NUMBER
SECONDARY	Proportion of Sphincter Preservation	assessed at primary surgery time	All randomized patients	proportion of patients	NUMBER
SECONDARY	Failure Pattern	assessed every 3 months withihn 2 years of study entry, every 6 monhts between years 3-5 and then annually for 5 years	All randomized patients	Participants	COUNT_OF_PARTICIPANTS

Source ClinicalTrials.gov

Results by group27

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

Outcome	Group	Category	Value	Spread	Units
3-year Overall Survival Rate	Irinocetan (Arm I)		0.965	95% Confidence Interval 0.868 to 0.991	proportion of patients
3-year Overall Survival Rate	Oxaliplatin (Arm II)		0.843	95% Confidence Interval 0.721 to 0.915	proportion of patients
3-year Overall Survival Rate	Control (Arm III)		0.870	95% Confidence Interval 0.757 to 0.933	proportion of patients
3-year Disease Free Survival	Irinocetan (Arm I)		0.670	95% Confidence Interval 0.533 to 0.776	proportion of patients
3-year Disease Free Survival	Oxaliplatin (Arm II)		0.717	95% Confidence Interval 0.580 to 0.816	proportion of patients
3-year Disease Free Survival	Control (Arm III)		0.704	95% Confidence Interval 0.572 to 0.802	proportion of patients
Proportion of Sphincter Preservation	Irinocetan (Arm I)		0.814	95% Confidence Interval 0.691 to 0.903	proportion of patients
Proportion of Sphincter Preservation	Oxaliplatin (Arm II)		0.724	95% Confidence Interval 0.591 to 0.833	proportion of patients
Proportion of Sphincter Preservation	Control (Arm III)		0.655	95% Confidence Interval 0.519 to 0.775	proportion of patients
Failure Pattern	Irinocetan (Arm I)	Local/regional recurrence only	3		Participants

1 to 10 of 27Source ClinicalTrials.gov

See all 27 results by group

Participant flow88

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

Period	Milestone	Group	Participants
Step 1: Registration	STARTED	Group I, Arm S	128
Step 1: Registration	STARTED	Group II, Arm T	97
Step 1: Registration	STARTED	Group I, Arm I	0
Step 1: Registration	STARTED	Group I, Arm II	0
Step 1: Registration	STARTED	Group I, Arm III	0
Step 1: Registration	STARTED	Group II, Arm I	0
Step 1: Registration	STARTED	Group II, Arm II	0
Step 1: Registration	STARTED	Group II, Arm III	0
Step 1: Registration	Started Concurrent Chemo/Radiation	Group I, Arm S	125
Step 1: Registration	Started Concurrent Chemo/Radiation	Group II, Arm T	0

1 to 10 of 88Source ClinicalTrials.gov

See all 88 participant flow

Adverse events714

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	Anemia	Blood and lymphatic system disorders	Arm S	15	123
other	Anemia	Blood and lymphatic system disorders	Group I, Arm I	7	27
other	Anemia	Blood and lymphatic system disorders	Group I, Arm II	3	22
other	Anemia	Blood and lymphatic system disorders	Group I, Arm III	1	28
other	Anemia	Blood and lymphatic system disorders	Group II, Arm I	2	31
other	Anemia	Blood and lymphatic system disorders	Group II, Arm II	2	33
other	Anemia	Blood and lymphatic system disorders	Group II, Arm III	4	32
other	Leukocytes decreased	Investigations	Arm S	7	123
other	Leukocytes decreased	Investigations	Group I, Arm I	4	27
other	Leukocytes decreased	Investigations	Group I, Arm II	2	22

1 to 10 of 714Source ClinicalTrials.gov

See all 714 adverse events

Adverse event totals21

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Arm S	1	123
Total, all-cause mortality	Group I, Arm I	8	27
Total, all-cause mortality	Group I, Arm II	12	22
Total, all-cause mortality	Group I, Arm III	11	28
Total, all-cause mortality	Group II, Arm I	11	31
Total, all-cause mortality	Group II, Arm II	9	33
Total, all-cause mortality	Group II, Arm III	10	32
Total, other adverse events	Arm S	27	123
Total, other adverse events	Group I, Arm I	7	27
Total, other adverse events	Group I, Arm II	3	22

1 to 10 of 21Source ClinicalTrials.gov

See all 21 adverse event totals

Papers1

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as
41397917	DERIVED

Source PubMed

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
U10CA021115	Eastern Cooperative Oncology Group Operations Office	COMIS, ROBERT L	FRONTIER SCI & TECHNOLOGY RSCH FDN, INC	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.

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