Trial · NCT00081289

Neoadjuvant Chemoradiotherapy and Adjuvant Chemotherapy in Treating Patients Who Are Undergoing Surgical Resection for Locally Advanced Rectal Cancer

NCT00081289, Phase 2, Completed, Radiation Therapy Oncology Group; results first posted 2013-11-25

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. Neoadjuvant Chemoradiotherapy and Adjuvant Chemotherapy in Treating Patients Who Are Undergoing Surgical Resection for Locally Advanced Rectal Cancer. Trials, record NCT00081289. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00081289

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Trial

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

Title: Neoadjuvant Chemoradiotherapy and Adjuvant Chemotherapy in Treating Patients Who Are Undergoing Surgical Resection for Locally Advanced Rectal Cancer
NCT number: NCT00081289
Status: Completed
Phases: Phase 2
Enrollment: 146 participants, actual
Lead sponsor: Radiation Therapy Oncology Group
Conditions: Colorectal Cancer
Interventions: Radiation Therapy, Capecitabine 1650 mg/m^2/day, Capecitabine 1200 mg/m^2/day, Irinotecan, Oxaliplatin, Surgery, Folinic Acid, Fluorouracil, Oxaliplatin
First posted: 2004-04-08
Last updated: 2020-02-27
Results first posted: 2013-11-25
Limitations and caveats: Due to excessive GI adverse events in the first 35 patients, chemotherapy dosage was modified and the protocol was amended (treatment descriptions reflect the revision). Therefore the first 35 patients are not included in outcome measure results.

Source ClinicalTrials.gov

Registered outcomes19

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

List	Outcome	Time frame	Description
Primary	Pathologic Complete Response Rate	After protocol surgery, approximately 10-16 weeks from randomization based on surgery occurring 4-8 weeks after chemoradiation	A pathologic complete response (pCR) was defined as no evidence of residual cancer histologically; disease progression or death before surgery was considered less than pCR (even without surgical specimen). All cases were reviewed by the study's surgical oncology co-chair for the determination of pCR. Each arm was first analyzed alone. If the arm had 9 or more pCRs in 48 evaluable pts, then the null hypothesis (H0) of 10% pCR rate would be rejected in favor of the alternative hypothesis of 25%, providing 90% power with a two-sided 10% type I error rate. If both arms reject H0, then statistical selection theory would be used to choose the arm for further study in a phase III trial. If only one arm has acceptable pCR rate, then that arm would be pursued in a phase III trial.
Secondary	Survival Rate at 4 Years	From randomization to four years	Survival time is defined as time from registration/randomization to the date of death from any cause or last known follow-up (censored). Survival rates are estimated by the Kaplan-Meier method.
Secondary	Local-regional Failure Rate at 4 Years	From randomization to four years	Local-regional failure is defined as any of the following: no clinical complete response (cCR) in the primary site and/or nodes at any time after treatment completion (persistence), recurrence and/or progression in the primary site and/or nodes after cCR, and nonprotocol surgery to the primary site after cCR. Time to local-regional failure is defined as time from randomization to date of failure, last known follow-up (censored), or death without local-regional failure (competing risk). Local-regional failure rates are estimated by the cumulative incidence method.
Secondary	Distant Failure Rate at 4 Years	From randomization to four years	Time to distant failure is defined as time from randomization to date of the appearance of distant metastases, last known follow-up (censored), or death without distant failure (competing risk). Distant failure rates are estimated by the cumulative incidence method.
Secondary	Second Primary Rate at 4 Years	From randomization to four years	Time to second primary is defined as time from randomization to date of the appearance of a second primary cancer, last known follow-up (censored), or death without second primary (competing risk). Second primary rates are estimated by the cumulative incidence method.
Secondary	Disease-free Survival Rate at 4 Years	From randomization to four years	Disease-free survival time is defined as time from randomization to date of local-regional failure, the appearance of distant metastases, the appearance of a second primary failure, or date of death from any cause/ Disease-free survival rates are estimated by the Kaplan-Meier method. Patients last known to be alive without failure are censored at the date of last contact.
Secondary	Number of Participants With Grade 3+ Treatment-related Adverse Events	From start of treatment to end of follow-up. Maximum follow-up is 5.2 years.	Highest grade adverse event per subject were counted. Adverse events were graded using the Common Terminology Criteria for Adverse Events (CTCAE) v3.0. Grade refers to the severity of the AE. The CTCAE v3.0 assigns Grades 1 through 5 with unique clinical descriptions of severity for each AE based on this general guideline: Grade 1 Mild AE, Grade 2 Moderate AE, Grade 3 Severe AE, Grade 4 Life-threatening or disabling AE, Grade 5 Death related to AE.
Secondary	Number of Participants With Grade 3+ Treatment-related Adverse Events Preoperatively	From start of treatment to surgery, approximately 10-16 weeks from randomization based on surgery occurring 4-8 weeks after chemoradiation. If no surgery, then <= 90 days from start of treatment.	Highest grade adverse event per subject were counted. Adverse events were graded using the Common Terminology Criteria for Adverse Events (CTCAE) v3.0. Grade refers to the severity of the AE. The CTCAE v3.0 assigns Grades 1 through 5 with unique clinical descriptions of severity for each AE based on this general guideline: Grade 1 Mild AE, Grade 2 Moderate AE, Grade 3 Severe AE, Grade 4 Life-threatening or disabling AE, Grade 5 Death related to AE.
Secondary	Number of Participants With Grade 3+ Treatment-related Adverse Events Postoperatively	From post-surgery to before chemotherapy (CT), or within 60 days of surgery if no postoperative CT. Approximately 10-16 weeks to 14-22 weeks from randomization based on CT starting 4-6 weeks after surgery.	Highest grade adverse event per subject were counted. Adverse events were graded using the Common Terminology Criteria for Adverse Events (CTCAE) v3.0. Grade refers to the severity of the AE. The CTCAE v3.0 assigns Grades 1 through 5 with unique clinical descriptions of severity for each AE based on this general guideline: Grade 1 Mild AE, Grade 2 Moderate AE, Grade 3 Severe AE, Grade 4 Life-threatening or disabling AE, Grade 5 Death related to AE.
Secondary	Tumor Marker Evaluation Using Preoperative Tissue Biopsy Specimens and Surgically Resected Tissue Specimens	End of study

1 to 10 of 19Source ClinicalTrials.gov

See all 19 registered outcomes

Outcomes19

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

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Pathologic Complete Response Rate	After protocol surgery, approximately 10-16 weeks from randomization based on surgery occurring 4-8 weeks after chemoradiation	For each arm the first 48 eligible enrolled after the protocol amendment.	percentage of participants	NUMBER
SECONDARY	Survival Rate at 4 Years	From randomization to four years	Eligible patients enrolled after the protocol amendment	percentage of participants	NUMBER
SECONDARY	Local-regional Failure Rate at 4 Years	From randomization to four years	Eligible patients enrolled after the protocol amendment	percentage of participants	NUMBER
SECONDARY	Distant Failure Rate at 4 Years	From randomization to four years	Eligible patients enrolled after the protocol amendment	percentage of participants	NUMBER
SECONDARY	Second Primary Rate at 4 Years	From randomization to four years	Eligible patients enrolled after the protocol amendment	percentage of participants	NUMBER
SECONDARY	Disease-free Survival Rate at 4 Years	From randomization to four years	Eligible patients enrolled after the protocol amendment	percentage of participants	NUMBER
SECONDARY	Number of Participants With Grade 3+ Treatment-related Adverse Events	From start of treatment to end of follow-up. Maximum follow-up is 5.2 years.	Eligible patients enrolled after the protocol amendment	Participants	COUNT_OF_PARTICIPANTS
SECONDARY	Number of Participants With Grade 3+ Treatment-related Adverse Events Preoperatively	From start of treatment to surgery, approximately 10-16 weeks from randomization based on surgery occurring 4-8 weeks after chemoradiation. If no surgery, then <= 90 days from start of treatment.	Eligible patients enrolled after the protocol amendment	Participants	COUNT_OF_PARTICIPANTS
SECONDARY	Number of Participants With Grade 3+ Treatment-related Adverse Events Postoperatively	From post-surgery to before chemotherapy (CT), or within 60 days of surgery if no postoperative CT. Approximately 10-16 weeks to 14-22 weeks from randomization based on CT starting 4-6 weeks after surgery.	Eligible patients enrolled after the protocol amendment who had surgery	Participants	COUNT_OF_PARTICIPANTS
SECONDARY	Tumor Marker Evaluation Using Preoperative Tissue Biopsy Specimens and Surgically Resected Tissue Specimens	End of study	The data required for this analysis was not obtained and will not be obtained.

1 to 10 of 19Source ClinicalTrials.gov

See all 19 outcomes

Results by group48

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

Outcome	Group	Value	Spread	Units
Pathologic Complete Response Rate	Neoadjuvant Chemoradiation With Irinotecan	10.4	95% Confidence Interval 3.5 to 22.7	percentage of participants
Pathologic Complete Response Rate	Neoadjuvant Chemoradiation With Oxaliplatin	20.8	95% Confidence Interval 10.5 to 35.0	percentage of participants
Survival Rate at 4 Years	Neoadjuvant Chemoradiation With Irinotecan	85	95% Confidence Interval 66 to 94	percentage of participants
Survival Rate at 4 Years	Neoadjuvant Chemoradiation With Oxaliplatin	75	95% Confidence Interval 60 to 85	percentage of participants
Local-regional Failure Rate at 4 Years	Neoadjuvant Chemoradiation With Irinotecan	16	95% Confidence Interval 6 to 27	percentage of participants
Local-regional Failure Rate at 4 Years	Neoadjuvant Chemoradiation With Oxaliplatin	18	95% Confidence Interval 7 to 28	percentage of participants
Distant Failure Rate at 4 Years	Neoadjuvant Chemoradiation With Irinotecan	24	95% Confidence Interval 11 to 38	percentage of participants
Distant Failure Rate at 4 Years	Neoadjuvant Chemoradiation With Oxaliplatin	30	95% Confidence Interval 17 to 43	percentage of participants
Second Primary Rate at 4 Years	Neoadjuvant Chemoradiation With Irinotecan	2	95% Confidence Interval 0 to 6	percentage of participants
Second Primary Rate at 4 Years	Neoadjuvant Chemoradiation With Oxaliplatin	6	95% Confidence Interval 0 to 13	percentage of participants

1 to 10 of 48Source ClinicalTrials.gov

See all 48 results by group

Participant flow32

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

Period	Milestone	Group	Participants
Overall Study	STARTED	Neoadjuvant Chemoradiation With Irinotecan	73
Overall Study	STARTED	Neoadjuvant Chemoradiation With Oxaliplatin	73
Overall Study	Primary Endpoint Population	Neoadjuvant Chemoradiation With Irinotecan	48
Overall Study	Primary Endpoint Population	Neoadjuvant Chemoradiation With Oxaliplatin	48
Overall Study	General Analysis Population	Neoadjuvant Chemoradiation With Irinotecan	52
Overall Study	General Analysis Population	Neoadjuvant Chemoradiation With Oxaliplatin	52
Overall Study	Full AE Population	Neoadjuvant Chemoradiation With Irinotecan	70
Overall Study	Full AE Population	Neoadjuvant Chemoradiation With Oxaliplatin	68
Overall Study	Surgery	Neoadjuvant Chemoradiation With Irinotecan	47
Overall Study	Surgery	Neoadjuvant Chemoradiation With Oxaliplatin	51

1 to 10 of 32Source ClinicalTrials.gov

See all 32 participant flow

Adverse events362

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	Blood/bone marrow - Other:	Blood and lymphatic system disorders	Neoadjuvant Chemoradiation With Irinotecan	1	70
other	Blood/bone marrow - Other:	Blood and lymphatic system disorders	Neoadjuvant Chemoradiation With Oxaliplatin	5	68
other	Hemoglobin	Blood and lymphatic system disorders	Neoadjuvant Chemoradiation With Irinotecan	50	70
other	Hemoglobin	Blood and lymphatic system disorders	Neoadjuvant Chemoradiation With Oxaliplatin	44	68
other	Abdominal pain NOS	Gastrointestinal disorders	Neoadjuvant Chemoradiation With Irinotecan	21	70
other	Abdominal pain NOS	Gastrointestinal disorders	Neoadjuvant Chemoradiation With Oxaliplatin	17	68
other	Constipation	Gastrointestinal disorders	Neoadjuvant Chemoradiation With Irinotecan	25	70
other	Constipation	Gastrointestinal disorders	Neoadjuvant Chemoradiation With Oxaliplatin	20	68
other	Diarrhoea NOS	Gastrointestinal disorders	Neoadjuvant Chemoradiation With Irinotecan	56	70
other	Diarrhoea NOS	Gastrointestinal disorders	Neoadjuvant Chemoradiation With Oxaliplatin	57	68

1 to 10 of 362Source ClinicalTrials.gov

See all 362 adverse events

Adverse event totals6

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Neoadjuvant Chemoradiation With Irinotecan
Total, all-cause mortality	Neoadjuvant Chemoradiation With Oxaliplatin
Total, other adverse events	Neoadjuvant Chemoradiation With Irinotecan	70	70
Total, other adverse events	Neoadjuvant Chemoradiation With Oxaliplatin	67	68
Total, serious adverse events	Neoadjuvant Chemoradiation With Irinotecan	37	70
Total, serious adverse events	Neoadjuvant Chemoradiation With Oxaliplatin	36	68

Source ClinicalTrials.gov

Papers1

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as
21775070	RESULT

Source PubMed

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 comparisons1

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

Comparison
Neoadjuvant Chemoradiation With Irinotecan vs Neoadjuvant Chemoradiation With Oxaliplatin: serious adverse events

Source 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/NCT00081289

GET https://conductscience.org/api/trials/v1/NCT00081289/results?page=2

API reference For AI assistants