Trial · NCT00114231

Capecitabine, Oxaliplatin, and Radiation Therapy in Treating Patients Who Are Undergoing Surgery for Stage I Rectal Cancer

NCT00114231, Phase 2, Completed, Alliance for Clinical Trials in Oncology; results first posted 2018-03-29

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. Capecitabine, Oxaliplatin, and Radiation Therapy in Treating Patients Who Are Undergoing Surgery for Stage I Rectal Cancer. Trials, record NCT00114231. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00114231

On this page

Trial

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

Title: Capecitabine, Oxaliplatin, and Radiation Therapy in Treating Patients Who Are Undergoing Surgery for Stage I Rectal Cancer
NCT number: NCT00114231
Status: Completed
Phases: Phase 2
Enrollment: 90 participants, actual
Lead sponsor: Alliance for Clinical Trials in Oncology
Conditions: Colorectal Cancer
Interventions: capecitabine, oxaliplatin, neoadjuvant therapy, radiation therapy
First posted: 2005-06-14
Last updated: 2018-03-29
Results first posted: 2018-03-29

Source ClinicalTrials.gov

Registered outcomes5

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

List	Outcome	Time frame	Description
Primary	3-Year Disease-free Survival	Up to 3 years	The primary endpoint was 3-year disease-free survival (DFS). Evidence of local recurrence, distant metastasis, or death from any cause within 3 years counted as events in the time-to-event Kaplan-Meier analysis of disease-free survival.
Secondary	R0 Resection Rate (Negative Margin Rate)	At time of surgery	The rate (percentage) of patients with negative resection margins after undergoing local excision is reported below.
Secondary	Morbidity and Mortality Rate	Up to 30 days	Morbidity and mortality after neoadjuvant cheoradiotherapy and local excision.
Secondary	Rate of Pathologic Complete Response of the Primary Tumor	Up to 5 years	The rate (percentage) of patients with pathologic complete response (pCR) is reported below. Pathologic response will be determined by comparing tumor width and stage in the surgical specimen with the same parameters as determined by pre-CRT ERUS: PATHOLOGIC COMPLETE RESPONSE (pCR): no residual tumor.
Secondary	Local Recurrence Rate	Up to 5 years	The local recurrence rate (percentage) is defined as the percentage of patients who had local recurrence as initial sites of failure at the end of follow-up.

Source ClinicalTrials.gov

Outcomes5

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

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	3-Year Disease-free Survival	Up to 3 years		percentage of patients	NUMBER
SECONDARY	R0 Resection Rate (Negative Margin Rate)	At time of surgery	Patients who had local excision are included in this analysis.	percentage of patients	NUMBER
SECONDARY	Morbidity and Mortality Rate	Up to 30 days		percentage of patients	NUMBER
SECONDARY	Rate of Pathologic Complete Response of the Primary Tumor	Up to 5 years	Patients assessable for pathology results were included in this analysis.	percentage of patients	NUMBER
SECONDARY	Local Recurrence Rate	Up to 5 years		percentage of patients	NUMBER

Source ClinicalTrials.gov

Results by group6

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

Outcome	Group	Category	Value	Spread	Units
3-Year Disease-free Survival	Treatment (Capecitabine, Oxaliplatin, Radiotherapy, Surgery)		88.2	95% Confidence Interval 81.3 to 95.8	percentage of patients
R0 Resection Rate (Negative Margin Rate)	Treatment (Capecitabine, Oxaliplatin, Radiotherapy, Surgery)		98.7		percentage of patients
Morbidity and Mortality Rate	Treatment (Capecitabine, Oxaliplatin, Radiotherapy, Surgery)	Mortality	6		percentage of patients
Morbidity and Mortality Rate	Treatment (Capecitabine, Oxaliplatin, Radiotherapy, Surgery)	Morbidity	10		percentage of patients
Rate of Pathologic Complete Response of the Primary Tumor	Treatment (Capecitabine, Oxaliplatin, Radiotherapy, Surgery)		44	95% Confidence Interval 32 to 55	percentage of patients
Local Recurrence Rate	Treatment (Capecitabine, Oxaliplatin, Radiotherapy, Surgery)		4		percentage of patients

Source ClinicalTrials.gov

Participant flow6

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

Period	Milestone	Group	Participants
Overall Study	STARTED	Original Dose Group	62
Overall Study	STARTED	Revised Dose Group	28
Overall Study	COMPLETED	Original Dose Group	53
Overall Study	COMPLETED	Revised Dose Group	26
Overall Study	NOT COMPLETED	Original Dose Group	9
Overall Study	NOT COMPLETED	Revised Dose Group	2

Source ClinicalTrials.gov

Adverse events228

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	Events
other	Blood disorder	Blood and lymphatic system disorders	Original Dose Group	0	57	0
other	Blood disorder	Blood and lymphatic system disorders	Revised Dose Group	1	27	1
other	Hemoglobin decreased	Blood and lymphatic system disorders	Original Dose Group	3	57	8
other	Hemoglobin decreased	Blood and lymphatic system disorders	Revised Dose Group	13	27	40
other	Lymphatic disorder	Blood and lymphatic system disorders	Original Dose Group	1	57	1
other	Lymphatic disorder	Blood and lymphatic system disorders	Revised Dose Group	0	27	0
other	Myocardial ischemia	Cardiac disorders	Original Dose Group	1	57	2
other	Myocardial ischemia	Cardiac disorders	Revised Dose Group	0	27	0
other	Sinus tachycardia	Cardiac disorders	Original Dose Group	0	57	0
other	Sinus tachycardia	Cardiac disorders	Revised Dose Group	1	27	1

1 to 10 of 228Source ClinicalTrials.gov

See all 228 adverse events

Adverse event totals6

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Original Dose Group	0	57
Total, all-cause mortality	Revised Dose Group	0	27
Total, other adverse events	Original Dose Group	32	57
Total, other adverse events	Revised Dose Group	25	27
Total, serious adverse events	Original Dose Group	6	57
Total, serious adverse events	Revised Dose Group	2	27

Source ClinicalTrials.gov

Papers3

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as	Source
17103255	BACKGROUND	PubMed
21755378	RESULT	PubMed
26474521	RESULT	PubMed

Grants2

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	Source
U10CA180821	Alliance for Clinical Trials in Oncology Operations Center	Galanis, Evanthia; Hahn, Olwen; Kozono, David	ALLIANCE NCTN FOUNDATION	NATIONAL CANCER INSTITUTE	2014 to 2026	NIH RePORTER
U10CA076001	ACOSOG Competing Renewal	BERTAGNOLLI, MONICA M	BRIGHAM AND WOMEN'S HOSPITAL	NATIONAL CANCER INSTITUTE	1998 to 2013	NIH RePORTER

Trial comparisons2

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

Comparison	Source
Original Dose Group vs Revised Dose Group: deaths from any cause	Trial comparisons
Original Dose Group vs Revised Dose Group: 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/NCT00114231

GET https://conductscience.org/api/trials/v1/NCT00114231/events?page=2

API reference For AI assistants