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NCT00324415 · ClinicalTrials.gov registry record · Phase 2
Combined Modality Therapy for Patients With With HIV and Stage I, Stage II, or Stage III Anal Cancer
A Phase 2 study, sponsored by AIDS Malignancy Consortium.
- Completed
- Registry status
- Phase 2
- Development phase
- 45
- Enrollment target
NCT00324415: Completed Phase 2 study, sponsored by AIDS Malignancy Consortium.
NCT00324415 is a Phase 2 study that has completed, run by AIDS Malignancy Consortium. The registered enrollment target is 45 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (66% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00324415, a Phase 2 study, has completed, sponsored by AIDS Malignancy Consortium.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 45 participants
- Enrollment target
Study Summary
RATIONALE: Drugs used in chemotherapy, such as cisplatin and fluorouracil, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Monoclonal antibodies, such as cetuximab, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances to them. Radiation therapy uses high-energy x-rays to kill tumor cells. Giving cisplatin, fluorouracil, and cetuximab together with radiation therapy may kill more tumor cells. PURPOSE: This phase II trial is studying how well giving cisplatin, fluorouracil, and cetuximab together with radiation therapy works in treating patients with HIV and stage I, stage II, or stage III anal cancer.
Primary Outcome
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
Interventions
- DRUG cisplatin
- DRUG fluorouracil
- BIOLOGICAL cetuximab
- RADIATION radiation therapy
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 45 participants |
| Start Date | 2006-09 |
| Est. Completion | 2016-05 |
| Phase | Phase 2 |
What the finished NCT00324415 record still lists
NCT00324415 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 45 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (66% lower).
The record links to 0 conditions, and to 4 interventions - of which cisplatin is the first listed.
NCT00324415 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00324415 about?
NCT00324415 is a clinical study titled "Combined Modality Therapy for Patients With With HIV and Stage I, Stage II, or Stage III Anal Cancer". RATIONALE: Drugs used in chemotherapy, such as cisplatin and fluorouracil, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Monoclonal antibodies, such as cetuximab, can block tumor growth in different ways. Some block the abili...
What is the current status of trial NCT00324415?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 45 participants. The study started on 2006-09. Estimated completion is 2016-05.
What interventions are being tested in trial NCT00324415?
The interventions under investigation include: cisplatin (DRUG), fluorouracil (DRUG), cetuximab (BIOLOGICAL), radiation therapy (RADIATION).
Who is sponsoring clinical trial NCT00324415?
This trial is sponsored by AIDS Malignancy Consortium, which has 45 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00324415's enrollment target sits among peer trials
45 1296th of 2000 higher than 679 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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