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NCT00265941 · ClinicalTrials.gov registry record · Phase 3
Radiation Therapy and Cisplatin With or Without Cetuximab in Treating Patients With Stage III or Stage IV Head and Neck Cancer
A Phase 3 study, sponsored by Radiation Therapy Oncology Group.
- Completed
- Registry status
- Phase 3
- Development phase
- 940
- Enrollment target
NCT00265941: Completed Phase 3 study, sponsored by Radiation Therapy Oncology Group.
NCT00265941 is a Phase 3 study that has completed, run by Radiation Therapy Oncology Group. The registered enrollment target is 940 participants, above the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (22% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00265941, a Phase 3 study, has completed, sponsored by Radiation Therapy Oncology Group.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 940 participants
- Enrollment target
Study Summary
RATIONALE: Radiation therapy uses high-energy x-rays to kill tumor cells. Drugs used in chemotherapy, such as cisplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Cisplatin may also make tumor cells more sensitive to radiation therapy. 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. Giving radiation therapy and cisplatin together with cetuximab may kill more tumor cells. It is not yet known whether radiation therapy and cisplatin are more effective with or without cetuximab in treating head and neck cancer. PURPOSE: This randomized phase III trial is studying radiation therapy, cisplatin, and cetuximab to see how well they work compared to radiation therapy and cisplatin in treating patients with stage III or stage IV head and neck cancer.
Primary Outcome
Progression-free survival (PFS) is defined as time from randomization to date of local, regional, or distant disease progression, or death from any cause. Patients last known to be alive without progression are censored at the date of last contact. Three-year rates were estimated by the Kaplan-Meier method. Local or regional progression is defined as an estimated increase in the size of the tumor (product of the perpendicular diameters of the two largest dimensions) of greater than 25%, taking a
Interventions
- DRUG cetuximab
- DRUG cisplatin
- RADIATION Intensity-modulated radiation therapy
- RADIATION Accelerated Fractionation by Concomitant Boost
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 940 participants |
| Start Date | 2005-11 |
| Est. Completion | 2022-05-20 |
| Phase | Phase 3 |
What the finished NCT00265941 record still lists
NCT00265941 is an interventional study that assigns participants to a tested intervention. The registered 940 participants enrollment target is mid-sized for trials with a published cap, above the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (22% higher).
The record links to 0 conditions, and to 4 interventions - of which cetuximab is the first listed.
NCT00265941 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00265941 about?
NCT00265941 is a clinical study titled "Radiation Therapy and Cisplatin With or Without Cetuximab in Treating Patients With Stage III or Stage IV Head and Neck Cancer". RATIONALE: Radiation therapy uses high-energy x-rays to kill tumor cells. Drugs used in chemotherapy, such as cisplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Cisplatin may also make tumor cells more sensitive to radi...
What is the current status of trial NCT00265941?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 940 participants. The study started on 2005-11. Estimated completion is 2022-05-20.
What interventions are being tested in trial NCT00265941?
The interventions under investigation include: cetuximab (DRUG), cisplatin (DRUG), Intensity-modulated radiation therapy (RADIATION), Accelerated Fractionation by Concomitant Boost (RADIATION).
Who is sponsoring clinical trial NCT00265941?
This trial is sponsored by Radiation Therapy Oncology Group, which has 144 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00265941's enrollment target sits among peer trials
940 337th of 2000 higher than 1,663 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 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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