Trial · NCT00324415
Combined Modality Therapy for Patients With With HIV and Stage I, Stage II, or Stage III Anal Cancer
NCT00324415, Phase 2, Completed, AIDS Malignancy Consortium; results first posted 2015-09-17
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Combined Modality Therapy for Patients With With HIV and Stage I, Stage II, or Stage III Anal Cancer. Trials, record NCT00324415. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00324415
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Combined Modality Therapy for Patients With With HIV and Stage I, Stage II, or Stage III Anal Cancer
- NCT number
- NCT00324415
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 45 participants, actual
- Lead sponsor
- AIDS Malignancy Consortium
- Conditions
- Anal Cancer
- Interventions
- cetuximab, cisplatin, fluorouracil, radiation therapy
- First posted
- 2006-05-11
- Last updated
- 2025-05-30
- Results first posted
- 2015-09-17
Source ClinicalTrials.gov
Registered outcomes11
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Locoregional Failure Rate at 3 Years | 3 years following completion of therapy | Patients will be classified into two groups for purposes of primary endpoint analysis: failure or no failure at 3 years (in the primary analysis, patients lost to follow-up prior to 3 years will be considered failures). For the secondary endpoint of objective response, patients will be classified as responders |
| Secondary | Progression-free Survival | 1 year | Progression-free survival at 1 year is the percentage of patients who are alive and have not experienced progressive disease, defined as at least a 20% increase in the sum of the longest diameter of target lesions, taking as reference the smallest sum longest diameter recorded since the treatment started, or the appearance of one or more new lesions. |
| Secondary | Relapse-free Survival | 1 year | Percentage of participants who are alive and have not experienced progressive disease and have not relapsed |
| Secondary | Colostomy-free Survival at 1 Year | 1 year | Percentage of participants who are alive and have not had a colostomy |
| Secondary | Overall Survival | 1 year | Percentage of participants who are alive at one year |
| Secondary | Quality of Life EORTC Global Score at 1 Year | 1 year | EORTC QLQ-C30 Global Score at 1 year. The EORTC QLQ-C30 is a validated questionnaire that evaluates quality of life. The global score is an overall score for quality of life that ranges from 0 to 100. Higher scores indicate between quality of life |
| Secondary | Number of Delayed Toxicities | 90 days following treatment discontinuation | Delayed toxicities are defined as toxicities that occur over 90 days following treatment completion |
| Secondary | Changes in CD4 Counts During and for 1 Year After Completion of Study Treatment | 1 year following treatment discontinuation | Change in absolute CD4 counts from start of treatment to 1 year after completion of study treatment |
| Secondary | Incidence of Opportunistic Illnesses | 1 year following treatment discontinuation | Incidence of opportunistic illnesses, including the development of AIDS during and for 1 year after completion of study treatment |
| Secondary | Objective Response Rate (Complete and Partial) | 3 years following treatment discontinuation | Number of participants with complete and partial responses based on the RECIST criteria |
1 to 10 of 11Source ClinicalTrials.gov
See all 11 registered outcomesOutcomes11
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Locoregional Failure Rate at 3 Years | 3 years following completion of therapy | percentage of participants | NUMBER | |
| SECONDARY | Progression-free Survival | 1 year | percentage of participants | NUMBER | |
| SECONDARY | Relapse-free Survival | 1 year | percentage of participants | NUMBER | |
| SECONDARY | Colostomy-free Survival at 1 Year | 1 year | percentage of participants | NUMBER | |
| SECONDARY | Overall Survival | 1 year | percentage of participants | NUMBER | |
| SECONDARY | Quality of Life EORTC Global Score at 1 Year | 1 year | The number of participants analyzed is the number of participants for whom quality of life questionnaires were completed at one year. | units on a scale | MEAN |
| SECONDARY | Number of Delayed Toxicities | 90 days following treatment discontinuation | events | NUMBER | |
| SECONDARY | Changes in CD4 Counts During and for 1 Year After Completion of Study Treatment | 1 year following treatment discontinuation | The number of participants analyzed is the number for whom absolute CD4 count data were available at baseline at at 1 year after study completion | cells/mm3 | MEDIAN |
| SECONDARY | Incidence of Opportunistic Illnesses | 1 year following treatment discontinuation | participants | NUMBER | |
| SECONDARY | Objective Response Rate (Complete and Partial) | 3 years following treatment discontinuation | participants | NUMBER |
1 to 10 of 11Source ClinicalTrials.gov
See all 11 outcomesResults by group37
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Locoregional Failure Rate at 3 Years | Combined Modality Therapy | LRF rate by including censored patients treated as failures | 42 | 95% Confidence Interval 28 to 56 | percentage of participants |
| Locoregional Failure Rate at 3 Years | Combined Modality Therapy | LRF rate as per Kaplan-Meier estimate | 20 | 95% Confidence Interval 10 to 37 | percentage of participants |
| Progression-free Survival | Combined Modality Therapy | 87.3 | 95% Confidence Interval 72.1 to 94.5 | percentage of participants | |
| Relapse-free Survival | Combined Modality Therapy | 83.1 | 95% Confidence Interval 67.8 to 91.6 | percentage of participants | |
| Colostomy-free Survival at 1 Year | Combined Modality Therapy | 92.4 | 95% Confidence Interval 78.3 to 97.5 | percentage of participants | |
| Overall Survival | Combined Modality Therapy | 92.8 | 95% Confidence Interval 79.4 to 97.7 | percentage of participants | |
| Quality of Life EORTC Global Score at 1 Year | Combined Modality Therapy | 78.9 | Standard Deviation 24.0 | units on a scale | |
| Number of Delayed Toxicities | Combined Modality Therapy | 5 | events | ||
| Changes in CD4 Counts During and for 1 Year After Completion of Study Treatment | Combined Modality Therapy | 102 | Full Range -403 to 669 | cells/mm3 | |
| Incidence of Opportunistic Illnesses | Combined Modality Therapy | 4 | participants |
1 to 10 of 37Source ClinicalTrials.gov
See all 37 results by groupParticipant flow3
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Combined Modality Therapy | 45 | |
| Overall Study | COMPLETED | Combined Modality Therapy | 45 | |
| Overall Study | NOT COMPLETED | Combined Modality Therapy | 0 |
Source ClinicalTrials.gov
Adverse events97
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 | Anemia | Blood and lymphatic system disorders | Combined Modality Therapy | 14 | 45 | 26 |
| other | Abdominal pain | Gastrointestinal disorders | Combined Modality Therapy | 3 | 45 | 3 |
| other | Constipation | Gastrointestinal disorders | Combined Modality Therapy | 7 | 45 | 7 |
| other | Anal pain | Gastrointestinal disorders | Combined Modality Therapy | 10 | 45 | 14 |
| other | Diarrhea | Gastrointestinal disorders | Combined Modality Therapy | 22 | 45 | 38 |
| other | Other GI disorders | Gastrointestinal disorders | Combined Modality Therapy | 9 | 45 | 21 |
| other | Oral mucositis | Gastrointestinal disorders | Combined Modality Therapy | 10 | 45 | 23 |
| other | Nausea | Gastrointestinal disorders | Combined Modality Therapy | 12 | 45 | 18 |
| other | Proctitis | Gastrointestinal disorders | Combined Modality Therapy | 5 | 45 | 7 |
| other | Rectal pain | Gastrointestinal disorders | Combined Modality Therapy | 3 | 45 | 4 |
1 to 10 of 97Source ClinicalTrials.gov
See all 97 adverse eventsAdverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Combined Modality Therapy | ||
| Total, other adverse events | Combined Modality Therapy | 41 | 45 |
| Total, serious adverse events | Combined Modality Therapy | 27 | 45 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 27937092 | RESULT |
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 |
|---|---|---|---|---|---|
| U01CA070019 | AMC OPERATIONS CENTER | LEE, JEANNETTE Y. | UNIVERSITY OF ALABAMA AT BIRMINGHAM | NATIONAL CANCER INSTITUTE | 1995 to 2005 |
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.
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/NCT00324415
GET https://conductscience.org/api/trials/v1/NCT00324415/results?page=2