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NCT00360971 · ClinicalTrials.gov registry record · Phase 3
Palifermin in Lessening Oral Mucositis in Patients Undergoing Radiation Therapy and Chemotherapy for Locally Advanced Head and Neck Cancer
A Phase 3 study, sponsored by Radiation Therapy Oncology Group.
- Terminated
- Registry status
- Phase 3
- Development phase
- 21
- Enrollment target
NCT00360971 is a Phase 3 study that was terminated before completion, run by Radiation Therapy Oncology Group. The registered enrollment target is 21 participants.
The verdict
NCT00360971, a Phase 3 study, was terminated before completion, sponsored by Radiation Therapy Oncology Group.
- TERMINATED
- Registry status
- Phase 3
- Development phase
- 21 participants
- Enrollment target
Study Summary
RATIONALE: Growth factors, such as palifermin, may lessen the severity of mucositis, or mouth sores, in patients receiving radiation therapy and chemotherapy for head and neck cancer. It is not yet known whether palifermin is more effective than a placebo in lessening mucositis in patients receiving radiation therapy and chemotherapy for head and neck cancer. PURPOSE: This randomized phase III trial is studying palifermin to see how well it works compared to a placebo in lessening oral mucositis in patients undergoing radiation therapy and chemotherapy for locally advanced head and neck cancer.
Interventions
- OTHER placebo
- DRUG cisplatin
- RADIATION radiation therapy
- BIOLOGICAL palifermin
- PROCEDURE neck dissection
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 21 participants |
| Start Date | 2006-07 |
| Est. Completion | 2009-02 |
| Phase | Phase 3 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00360971
The ClinicalTrials.gov registry entry for NCT00360971 describes a study currently listed as terminated, categorized as Phase 3. The registered enrollment target is 21 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Radiation Therapy Oncology Group, which has 144 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 5 interventions - of which placebo is the first listed.
NCT00360971 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00360971 about?
NCT00360971 is a clinical study titled "Palifermin in Lessening Oral Mucositis in Patients Undergoing Radiation Therapy and Chemotherapy for Locally Advanced Head and Neck Cancer". RATIONALE: Growth factors, such as palifermin, may lessen the severity of mucositis, or mouth sores, in patients receiving radiation therapy and chemotherapy for head and neck cancer. It is not yet known whether palifermin is more effective than a placebo in lessening mucositis in patients receiving...
What is the current status of trial NCT00360971?
This trial is currently terminated. It is a Phase 3 study. The enrollment target is 21 participants. The study started on 2006-07. Estimated completion is 2009-02.
What interventions are being tested in trial NCT00360971?
The interventions under investigation include: placebo (OTHER), cisplatin (DRUG), radiation therapy (RADIATION), palifermin (BIOLOGICAL), neck dissection (PROCEDURE).
Who is sponsoring clinical trial NCT00360971?
This trial is sponsored by Radiation Therapy Oncology Group, which has 144 total clinical trials registered on ClinicalTrials.gov.
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