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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: Clinical Trial Phase 3 study, sponsored by Radiation Therapy Oncology Group.
NCT00360971 is a Phase 3 study that was terminated before completion, run by Radiation Therapy Oncology Group. The registered enrollment target is 21 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (97% lower). According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
Duration in days of World Heath Organization (WHO) Grades 3 and 4 oral mucositis during the acute period (defined to be 105 days \[15 weeks\] or less from the start of treatment); duration is calculated from the onset of a Grade 3 or 4 oral mucositis to the day when an oral mucositis of ≤ Grade 2 is reported after the last oral mucositis of Grade 3 or 4. Patients with grade 0-2 mucositis have a duration of 0. This study required 298 patients to detect via two-sided t-test a reduction of mean du
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 |
Why NCT00360971 stopped before completion
NCT00360971 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 21 participants, a relatively small participant target, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (97% lower).
The record links to 0 conditions, and to 5 interventions - of which placebo is the first listed.
NCT00360971 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00360971's enrollment target sits among peer trials
21 1953rd of 2000 higher than 45 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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