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NCT00566540 · ClinicalTrials.gov registry record · Phase 2
Ph 2 Intensification Regimen for Previously Untreated, Resectable, Advanced Squamous Cell Cancer
A Phase 2 study, sponsored by Ohio State University Comprehensive Cancer Center.
- Terminated
- Registry status
- Phase 2
- Development phase
- 11
- Enrollment target
NCT00566540: Clinical Trial Phase 2 study, sponsored by Ohio State University Comprehensive Cancer Center.
NCT00566540 is a Phase 2 study that was terminated before completion, run by Ohio State University Comprehensive Cancer Center. The registered enrollment target is 11 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (92% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00566540, a Phase 2 study, was terminated before completion, sponsored by Ohio State University Comprehensive Cancer Center.
- TERMINATED
- Registry status
- Phase 2
- Development phase
- 11 participants
- Enrollment target
Study Summary
RATIONALE: Drugs used in chemotherapy, such as cisplatin and paclitaxel, 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. Giving combination chemotherapy together with radiation therapy before surgery may make the tumor smaller and reduce the amount of normal tissue that needs to be removed. Giving these treatments after surgery may kill any tumor cells that remain after surgery. PURPOSE: This phase II trial is studying how well giving cisplatin and paclitaxel together with radiation therapy and surgery works in treating patients with advanced cancer of the oral cavity, oropharynx, or hypopharynx that can be removed by surgery.
Primary Outcome
Determine the feasibility of a new intensification regimen for previously untreated resectable advanced stage head and neck cancer that incorporates Cisplatin, Paclitaxel combined with surgery, submandibular gland transfer and radiation therapy
Interventions
- DRUG Cisplatin
- DRUG Paclitaxel
- RADIATION Intensity-Modulated Radiation Therapy (IMRT) External Beam Radiation
- PROCEDURE Triple endoscopy and biopsy
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 11 participants |
| Start Date | 2007-12-11 |
| Est. Completion | 2010-02-25 |
| Phase | Phase 2 |
Why NCT00566540 stopped before completion
NCT00566540 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 11 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (92% lower).
The record links to 0 conditions, and to 4 interventions - of which Cisplatin is the first listed.
NCT00566540 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00566540 about?
NCT00566540 is a clinical study titled "Ph 2 Intensification Regimen for Previously Untreated, Resectable, Advanced Squamous Cell Cancer". RATIONALE: Drugs used in chemotherapy, such as cisplatin and paclitaxel, 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. Giving combination chemotherapy together wi...
What is the current status of trial NCT00566540?
This trial is currently terminated. It is a Phase 2 study. The enrollment target is 11 participants. The study started on 2007-12-11. Estimated completion is 2010-02-25.
What interventions are being tested in trial NCT00566540?
The interventions under investigation include: Cisplatin (DRUG), Paclitaxel (DRUG), Intensity-Modulated Radiation Therapy (IMRT) External Beam Radiation (RADIATION), Triple endoscopy and biopsy (PROCEDURE).
Who is sponsoring clinical trial NCT00566540?
This trial is sponsored by Ohio State University Comprehensive Cancer Center, which has 341 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00566540's enrollment target sits among peer trials
11 1967th of 2000 higher than 33 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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