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NCT00068237 · ClinicalTrials.gov registry record · Phase 2
Salivary Gland Surgery Before Radiation Therapy in Preventing Radiation-Caused Xerostomia in Patients With Head and Neck Cancer
A Phase 2 study, sponsored by Radiation Therapy Oncology Group.
- Completed
- Registry status
- Phase 2
- Development phase
- 49
- Enrollment target
NCT00068237: Completed Phase 2 study, sponsored by Radiation Therapy Oncology Group.
NCT00068237 is a Phase 2 study that has completed, run by Radiation Therapy Oncology Group. The registered enrollment target is 49 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (63% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00068237, a Phase 2 study, has completed, sponsored by Radiation Therapy Oncology Group.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 49 participants
- Enrollment target
Study Summary
RATIONALE: Moving a salivary gland out of the area that will undergo radiation therapy may protect the gland from side effects of radiation therapy and may prevent xerostomia (dry mouth). PURPOSE: Phase II trial to study the effectiveness of salivary gland surgery in preventing xerostomia in patients who are undergoing radiation therapy for head and neck cancer.
Primary Outcome
Surgery will be scored as "per protocol prescription" if scored as such by both central reviewers- the Study Chair and the Radiation Therapy Oncology Group Head and Neck Committee Surgical Chair. If 21 or more of 43 subjects are scored as having surgery "per protocol prescription", then the technique will be considered reproducible with 80% power and 5% type I error using Simon's two stage design with unacceptable/acceptable rates set at 60%/80%.
Interventions
- PROCEDURE salivary gland transfer
- RADIATION Post-operative radiation therapy
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 49 participants |
| Start Date | 2003-08 |
| Est. Completion | 2016-12 |
| Phase | Phase 2 |
What the finished NCT00068237 record still lists
NCT00068237 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 49 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (63% lower).
The record links to 0 conditions, and to 2 interventions - of which salivary gland transfer is the first listed.
NCT00068237 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00068237 about?
NCT00068237 is a clinical study titled "Salivary Gland Surgery Before Radiation Therapy in Preventing Radiation-Caused Xerostomia in Patients With Head and Neck Cancer". RATIONALE: Moving a salivary gland out of the area that will undergo radiation therapy may protect the gland from side effects of radiation therapy and may prevent xerostomia (dry mouth). PURPOSE: Phase II trial to study the effectiveness of salivary gland surgery in preventing xerostomia in patien...
What is the current status of trial NCT00068237?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 49 participants. The study started on 2003-08. Estimated completion is 2016-12.
What interventions are being tested in trial NCT00068237?
The interventions under investigation include: salivary gland transfer (PROCEDURE), Post-operative radiation therapy (RADIATION).
Who is sponsoring clinical trial NCT00068237?
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 NCT00068237's enrollment target sits among peer trials
49 1261st of 2000 higher than 736 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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