Trial · NCT00527111

Pre-op Rectal ChemoRad +/- Cetuximab

NCT00527111, Phase 2, Completed, US Oncology Research; results first posted 2016-11-03

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. Pre-op Rectal ChemoRad +/- Cetuximab. Trials, record NCT00527111. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00527111

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Trial

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

Title: Pre-op Rectal ChemoRad +/- Cetuximab
NCT number: NCT00527111
Status: Completed
Phases: Phase 2
Enrollment: 139 participants, actual
Lead sponsor: US Oncology Research
Conditions: Rectal Cancer
Interventions: Cetuximab, 5-fluorouracil, Pelvic irradiation
First posted: 2007-09-10
Last updated: 2016-11-03
Results first posted: 2016-11-03

Source ClinicalTrials.gov

Registered outcomes5

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

List	Outcome	Time frame	Description
Primary	Percentage of Pathologic Response Rate (pCR) With 95% Confidence Interval.	5 years	A pathologic complete response (pCR) is defined as no pathologic evidence of invasive disease at the primary site in the bowel wall or in examined mesorectal tissue and/or lymph nodes.
Secondary	To Determine Objective Response Rate (ORR) Based on RECIST Local Recurrence-free Survival in These Patient Groups; Overall and Recurrence-free Survival in These Cohorts.	5 years	Complete Response (CR): Disappearance of all target lesions. Partial Response (PR): At least a 30% decrease in the sum of the LD of target lesions taking as reference the baseline sum LD.
Secondary	5- Year Overall Survival (OS) Rate	5 years	Overall survival is measured from the date of randomization to the date of death for a dead patient. If a patient is still alive or is lost to follow up, the patient will be censored at the date of last contact.
Secondary	Recurrence-free Survival (RFS) Rate at 5 Years	5 years	RFS is measured from the date of randomization to the date of first documented disease recurrence or date of death, whichever comes first. If a patient neither recurrences nor dies, this patient will be censored at the date of last contact.
Secondary	KRAS Mutation Rate	5 years	Percentage of Participants with KRAS mutation.

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	Percentage of Pathologic Response Rate (pCR) With 95% Confidence Interval.	5 years	Post surgery population	percentage of participants	NUMBER
SECONDARY	To Determine Objective Response Rate (ORR) Based on RECIST Local Recurrence-free Survival in These Patient Groups; Overall and Recurrence-free Survival in These Cohorts.	5 years	Evaluable Population	percentage of participants	NUMBER
SECONDARY	5- Year Overall Survival (OS) Rate	5 years	ITT population	probability of overall survival	NUMBER
SECONDARY	Recurrence-free Survival (RFS) Rate at 5 Years	5 years	ITT population	probability of recurrence-free survival	NUMBER
SECONDARY	KRAS Mutation Rate	5 years	ITT population with KRAS test	percentage of participants with mutation	NUMBER

Source ClinicalTrials.gov

Results by group10

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

Outcome	Group	Value	Spread	Units
Percentage of Pathologic Response Rate (pCR) With 95% Confidence Interval.	Chemoradiotherapy Plus Cetuximab	26.6	95% Confidence Interval 16.3 to 39.1	percentage of participants
Percentage of Pathologic Response Rate (pCR) With 95% Confidence Interval.	Chemoradiotherapy Alone	26.7	95% Confidence Interval 16.1 to 39.7	percentage of participants
To Determine Objective Response Rate (ORR) Based on RECIST Local Recurrence-free Survival in These Patient Groups; Overall and Recurrence-free Survival in These Cohorts.	Chemoradiotherapy Plus Cetuximab	52.2	95% Confidence Interval 39.7 to 64.6	percentage of participants
To Determine Objective Response Rate (ORR) Based on RECIST Local Recurrence-free Survival in These Patient Groups; Overall and Recurrence-free Survival in These Cohorts.	Chemoradiotherapy Alone	43.5	95% Confidence Interval 31.0 to 56.7	percentage of participants
5- Year Overall Survival (OS) Rate	Chemoradiotherapy Plus Cetuximab	0.81	95% Confidence Interval 0.69 to 0.89	probability of overall survival
5- Year Overall Survival (OS) Rate	Chemoradiotherapy Alone	0.68	95% Confidence Interval 0.53 to 0.79	probability of overall survival
Recurrence-free Survival (RFS) Rate at 5 Years	Chemoradiotherapy Plus Cetuximab	0.65	95% Confidence Interval 0.51 to 0.76	probability of recurrence-free survival
Recurrence-free Survival (RFS) Rate at 5 Years	Chemoradiotherapy Alone	0.585	95% Confidence Interval 0.44 to 0.71	probability of recurrence-free survival
KRAS Mutation Rate	Chemoradiotherapy Plus Cetuximab	32.5		percentage of participants with mutation
KRAS Mutation Rate	Chemoradiotherapy Alone	44.0		percentage of participants with mutation

Source ClinicalTrials.gov

Participant flow6

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

Period	Milestone	Group	Participants
Overall Study	STARTED	Chemoradiotherapy Plus Cetuximab	70
Overall Study	STARTED	Chemoradiotherapy Alone	69
Overall Study	COMPLETED	Chemoradiotherapy Plus Cetuximab	50
Overall Study	COMPLETED	Chemoradiotherapy Alone	47
Overall Study	NOT COMPLETED	Chemoradiotherapy Plus Cetuximab	20
Overall Study	NOT COMPLETED	Chemoradiotherapy Alone	22

Source ClinicalTrials.gov

Adverse events76

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	ABDOMINAL PAIN	Gastrointestinal disorders	Chemoradiotherapy Plus Cetuximab	5	67	6
other	ABDOMINAL PAIN	Gastrointestinal disorders	Chemoradiotherapy Alone	8	62	8
other	ANEMIA	Blood and lymphatic system disorders	Chemoradiotherapy Plus Cetuximab	5	67	6
other	ANEMIA	Blood and lymphatic system disorders	Chemoradiotherapy Alone	6	62	8
other	ANOREXIA	Gastrointestinal disorders	Chemoradiotherapy Plus Cetuximab	16	67	19
other	ANOREXIA	Gastrointestinal disorders	Chemoradiotherapy Alone	13	62	15
other	CHILLS	General disorders	Chemoradiotherapy Plus Cetuximab	7	67	7
other	CHILLS	General disorders	Chemoradiotherapy Alone	1	62	1
other	CONSTIPATION	Gastrointestinal disorders	Chemoradiotherapy Plus Cetuximab	8	67	9
other	CONSTIPATION	Gastrointestinal disorders	Chemoradiotherapy Alone	5	62	5

1 to 10 of 76Source ClinicalTrials.gov

See all 76 adverse events

Adverse event totals6

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Chemoradiotherapy Plus Cetuximab
Total, all-cause mortality	Chemoradiotherapy Alone
Total, other adverse events	Chemoradiotherapy Plus Cetuximab	61	67
Total, other adverse events	Chemoradiotherapy Alone	47	62
Total, serious adverse events	Chemoradiotherapy Plus Cetuximab	10	67
Total, serious adverse events	Chemoradiotherapy Alone	5	62

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 comparisons1

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

Comparison
Chemoradiotherapy Plus Cetuximab vs Chemoradiotherapy Alone: 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/NCT00527111

GET https://conductscience.org/api/trials/v1/NCT00527111/events?page=2

API reference For AI assistants