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NCT00316888 · ClinicalTrials.gov registry record · Phase 2
Cetuximab, Cisplatin, Fluorouracil, and Radiation Therapy in Treating Patients With Anal Cancer
A Phase 2 study, sponsored by ECOG-ACRIN Cancer Research Group.
- Completed
- Registry status
- Phase 2
- Development phase
- 63
- Enrollment target
NCT00316888: Completed Phase 2 study, sponsored by ECOG-ACRIN Cancer Research Group.
NCT00316888 is a Phase 2 study that has completed, run by ECOG-ACRIN Cancer Research Group. The registered enrollment target is 63 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (53% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00316888, a Phase 2 study, has completed, sponsored by ECOG-ACRIN Cancer Research Group.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 63 participants
- Enrollment target
Study Summary
RATIONALE: Monoclonal antibodies, such as cetuximab, can block tumor growth in different ways. Some find tumor cells and kill them or carry tumor-killing substances to them. Others interfere with the ability of tumor cells to grow and spread. 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. Radiation therapy uses high-energy x-rays to kill tumor cells. Cetuximab may help cisplatin and fluorouracil work better by making tumor cells more sensitive to the drugs. It may also make tumor cells more sensitive to radiation therapy. Giving cetuximab together with chemotherapy and radiation therapy may kill more tumor cells. PURPOSE: This phase II trial is studying how well giving cetuximab together with cisplatin, fluorouracil, and radiation therapy works in treating immunocompetent patients with stage I (closed to accrual as of 11/3/2008), stage II, (some stage II closed to accrual as of 11/3/2008) or stage III anal cancer.
Primary Outcome
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
Interventions
- DRUG cisplatin
- DRUG fluorouracil
- BIOLOGICAL cetuximab
- RADIATION radiotherapy
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 63 participants |
| Start Date | 2007-02-28 |
| Est. Completion | 2021-08-17 |
| Phase | Phase 2 |
What the finished NCT00316888 record still lists
NCT00316888 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 63 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (53% lower).
The record links to 0 conditions, and to 4 interventions - of which cisplatin is the first listed.
NCT00316888 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00316888 about?
NCT00316888 is a clinical study titled "Cetuximab, Cisplatin, Fluorouracil, and Radiation Therapy in Treating Patients With Anal Cancer". RATIONALE: Monoclonal antibodies, such as cetuximab, can block tumor growth in different ways. Some find tumor cells and kill them or carry tumor-killing substances to them. Others interfere with the ability of tumor cells to grow and spread. Drugs used in chemotherapy, such as cisplatin and fluorou...
What is the current status of trial NCT00316888?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 63 participants. The study started on 2007-02-28. Estimated completion is 2021-08-17.
What interventions are being tested in trial NCT00316888?
The interventions under investigation include: cisplatin (DRUG), fluorouracil (DRUG), cetuximab (BIOLOGICAL), radiotherapy (RADIATION).
Who is sponsoring clinical trial NCT00316888?
This trial is sponsored by ECOG-ACRIN Cancer Research Group, which has 75 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00316888's enrollment target sits among peer trials
63 1009th of 2000 higher than 985 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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