Trial · NCT00316888
Cetuximab, Cisplatin, Fluorouracil, and Radiation Therapy in Treating Patients With Anal Cancer
NCT00316888, Phase 2, Completed, ECOG-ACRIN Cancer Research Group; results first posted 2016-08-29
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Cetuximab, Cisplatin, Fluorouracil, and Radiation Therapy in Treating Patients With Anal Cancer. Trials, record NCT00316888. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00316888
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Cetuximab, Cisplatin, Fluorouracil, and Radiation Therapy in Treating Patients With Anal Cancer
- NCT number
- NCT00316888
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 63 participants, actual
- Lead sponsor
- ECOG-ACRIN Cancer Research Group
- Conditions
- Anal Cancer
- Interventions
- cetuximab, cisplatin, fluorouracil, radiotherapy
- First posted
- 2006-04-21
- Last updated
- 2023-06-29
- Results first posted
- 2016-08-29
Source ClinicalTrials.gov
Registered outcomes5
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Local Failure Rate at 3 Years | assessed every 3 months for patients within 2 years of registration, then every 6 months for patients in year 3 | Local failure was defined as progression/relapse of disease in the anal canal and/or regional organs and/or regional lymph nodes after completion of protocol therapy, or progression during protocol therapy. Lost to follow-up and death (regardless of cause of death) prior to 3 years were also considered as local failures. For the calculation of local failure rate at 3 years, patients were classified into two groups (ie, coded as binary variable): failure (patients with local failure events prior to 3 years) vs. no failure (patients who still alive and had no local failure at 3 years). The binomial proportion and its exact two-sided 80% confidence interval (CI) were used to estimate it. |
| Secondary | 3-year Overall Survival Rate | assessed every 3 months for patients within 2 years of registration, then every 6 months for patients in year 3 | Overall survival (OS) is defined as time from registration to death from any cause. Patients alive are censored at the last contact date. Kaplan-Meier method was used to estimate the 3-year OS rate. |
| Secondary | 3-year Progression-free Survival Rate | assessed every 3 months for patients within 2 years of registration, then every 6 months for patients in year 3 | Progression-free survival (PFS) was defined as time from registration to disease progression, relapse or death (whichever occurred first), censoring cases without PFS events at the date of last disease assessment documenting the patient was free of progression/relapse. Progression was defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions. Kaplan-Meier method was used to estimate the 3-year PFS rate. |
| Secondary | Objective Response Rate | Tumor assessments were made at baseline, within 4 weeks of the completion of protocol treatment, then every 6 months if patient was 1-4 years from registration, yearly if patient was 5-10 years from registration until progression/relapse using the RECIST | Objective response rate is defined as number of patients with complete response (CR) or partial response (PR) divided by all eligible and treated patients. Responses are evaluated using the revised Response Evaluation Criteria in Solid Tumors (RECIST) guideline. CR is defined as disappearance of all target and non-target lesions. PR is defined as at least a 30% decrease in the sum of the diameters of target lesions (taking as reference the baseline sum diameters), and/or persistence of one or more non-target lesion(s). |
| Secondary | 3-year Colostomy-free Survival Rate | assessed every 3 months for patients within 2 years of registration, then every 6 months for patients in year 3 | Colostomy-free survival was defined as time from registration until time of colostomy or death without colostomy, censoring cases without colostomy at the data of last disease assessment documenting the patient was free of colostomy. Kaplan-Meier method was used to estimate the 3-year colostomy-free survival rate. |
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 | Local Failure Rate at 3 Years | assessed every 3 months for patients within 2 years of registration, then every 6 months for patients in year 3 | eligible and treated patients | proportion of participants | NUMBER |
| SECONDARY | 3-year Overall Survival Rate | assessed every 3 months for patients within 2 years of registration, then every 6 months for patients in year 3 | eligible and treated patients | proportion of participants | NUMBER |
| SECONDARY | 3-year Progression-free Survival Rate | assessed every 3 months for patients within 2 years of registration, then every 6 months for patients in year 3 | eligible and treated patients | proportion of participants | NUMBER |
| SECONDARY | Objective Response Rate | Tumor assessments were made at baseline, within 4 weeks of the completion of protocol treatment, then every 6 months if patient was 1-4 years from registration, yearly if patient was 5-10 years from registration until progression/relapse using the RECIST | eligible and treated patients | proportion of participants | NUMBER |
| SECONDARY | 3-year Colostomy-free Survival Rate | assessed every 3 months for patients within 2 years of registration, then every 6 months for patients in year 3 | eligible and treated patients who did not have permanent colostomy at study entry | proportion of participants | NUMBER |
Source ClinicalTrials.gov
Results by group10
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Local Failure Rate at 3 Years | Arm I (Closed to Accrual as of 11/3/2008) | 0.259 | 80% Confidence Interval 0.150 to 0.397 | proportion of participants | |
| Local Failure Rate at 3 Years | Arm II (Open to Accrual on 8/18/2009) | 0.353 | 80% Confidence Interval 0.243 to 0.477 | proportion of participants | |
| 3-year Overall Survival Rate | Arm I (Closed to Accrual as of 11/3/2008) | 0.887 | 95% Confidence Interval 0.690 to 0.962 | proportion of participants | |
| 3-year Overall Survival Rate | Arm II (Open to Accrual on 8/18/2009) | 0.789 | 95% Confidence Interval 0.606 to 0.893 | proportion of participants | |
| 3-year Progression-free Survival Rate | Arm I (Closed to Accrual as of 11/3/2008) | 0.809 | 95% Confidence Interval 0.600 to 0.916 | proportion of participants | |
| 3-year Progression-free Survival Rate | Arm II (Open to Accrual on 8/18/2009) | 0.616 | 95% Confidence Interval 0.432 to 0.756 | proportion of participants | |
| Objective Response Rate | Arm I (Closed to Accrual as of 11/3/2008) | 0.630 | 95% Confidence Interval 0.424 to 0.806 | proportion of participants | |
| Objective Response Rate | Arm II (Open to Accrual on 8/18/2009) | 0.647 | 95% Confidence Interval 0.465 to 0.802 | proportion of participants | |
| 3-year Colostomy-free Survival Rate | Arm I (Closed to Accrual as of 11/3/2008) | 0.849 | 95% Confidence Interval 0.645 to 0.940 | proportion of participants | |
| 3-year Colostomy-free Survival Rate | Arm II (Open to Accrual on 8/18/2009) | 0.657 | 95% Confidence Interval 0.446 to 0.804 | proportion of participants |
Source ClinicalTrials.gov
Participant flow14
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Arm I (Closed to Accrual as of 11/3/2008) | 28 | |
| Overall Study | STARTED | Arm II (Open to Accrual on 8/18/2009) | 35 | |
| Overall Study | Eligible | Arm I (Closed to Accrual as of 11/3/2008) | 28 | |
| Overall Study | Eligible | Arm II (Open to Accrual on 8/18/2009) | 35 | |
| Overall Study | Treated | Arm I (Closed to Accrual as of 11/3/2008) | 28 | |
| Overall Study | Treated | Arm II (Open to Accrual on 8/18/2009) | 34 | |
| Overall Study | Started Induction Chemotherapy | Arm I (Closed to Accrual as of 11/3/2008) | 28 | |
| Overall Study | Started Induction Chemotherapy | Arm II (Open to Accrual on 8/18/2009) | 0 | |
| Overall Study | Started Chemo+Radiation+Cetuximab | Arm I (Closed to Accrual as of 11/3/2008) | 27 | |
| Overall Study | Started Chemo+Radiation+Cetuximab | Arm II (Open to Accrual on 8/18/2009) | 34 |
1 to 10 of 14Source ClinicalTrials.gov
See all 14 participant flowAdverse events250
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 | Tinnitus | Ear and labyrinth disorders | Arm I (Closed to Accrual as of 11/3/2008) | 3 | 28 | |
| other | Tinnitus | Ear and labyrinth disorders | Arm II (Open to Accrual on 8/18/2009) | 1 | 34 | |
| other | Anemia | Blood and lymphatic system disorders | Arm I (Closed to Accrual as of 11/3/2008) | 11 | 28 | |
| other | Anemia | Blood and lymphatic system disorders | Arm II (Open to Accrual on 8/18/2009) | 12 | 34 | |
| other | Leukocytes decreased | Investigations | Arm I (Closed to Accrual as of 11/3/2008) | 15 | 28 | |
| other | Leukocytes decreased | Investigations | Arm II (Open to Accrual on 8/18/2009) | 11 | 34 | |
| other | Lymphopenia | Investigations | Arm I (Closed to Accrual as of 11/3/2008) | 2 | 28 | |
| other | Lymphopenia | Investigations | Arm II (Open to Accrual on 8/18/2009) | 1 | 34 | |
| other | Neutrophils decreased | Investigations | Arm I (Closed to Accrual as of 11/3/2008) | 11 | 28 | |
| other | Neutrophils decreased | Investigations | Arm II (Open to Accrual on 8/18/2009) | 7 | 34 |
1 to 10 of 250Source ClinicalTrials.gov
See all 250 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Arm I (Closed to Accrual as of 11/3/2008) | ||
| Total, all-cause mortality | Arm II (Open to Accrual on 8/18/2009) | ||
| Total, other adverse events | Arm I (Closed to Accrual as of 11/3/2008) | 28 | 28 |
| Total, other adverse events | Arm II (Open to Accrual on 8/18/2009) | 34 | 34 |
| Total, serious adverse events | Arm I (Closed to Accrual as of 11/3/2008) | 26 | 28 |
| Total, serious adverse events | Arm II (Open to Accrual on 8/18/2009) | 29 | 34 |
Source ClinicalTrials.gov
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 comparisons1
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison |
|---|
| Arm I (Closed to Accrual as of 11/3/2008) vs Arm II (Open to Accrual on 8/18/2009): 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.
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/NCT00316888
GET https://conductscience.org/api/trials/v1/NCT00316888/events?page=2