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NCT00057785 · ClinicalTrials.gov registry record · Phase 2
Radiation Therapy With or Without Chemotherapy in Reducing Mouth Dryness in Patients With Nasopharyngeal Cancer
A Phase 2 study, sponsored by Radiation Therapy Oncology Group.
- Completed
- Registry status
- Phase 2
- Development phase
- 68
- Enrollment target
NCT00057785: Completed Phase 2 study, sponsored by Radiation Therapy Oncology Group.
NCT00057785 is a Phase 2 study that has completed, run by Radiation Therapy Oncology Group. The registered enrollment target is 68 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (49% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00057785, a Phase 2 study, has completed, sponsored by Radiation Therapy Oncology Group.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 68 participants
- Enrollment target
Study Summary
RATIONALE: Radiation therapy uses high-energy x-rays to damage tumor cells. Giving radiation therapy in different ways may cause less damage to normal tissue, prevent or lessen mouth dryness, and may help patients live more comfortably. Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining chemotherapy with radiation therapy may kill more tumor cells. PURPOSE: Phase II trial to study the effectiveness of specialized radiation therapy techniques with or without chemotherapy in reducing mouth dryness in patients who have nasopharyngeal cancer.
Primary Outcome
Patients scored by the study chairs as no variation or minor variation were considered compliant, while patients scored as major variation or inevaluable were considered non-compliant. The number being reported is the number non-compliant. A compliance rate of 90% was targeted with 75% or lower being considered unacceptable. Fifty-seven patients were required with types I and II error rates both 0.10. If 10 or more patients out of 57 were non-compliant, the treatment would be unacceptable, per a
Interventions
- DRUG cisplatin
- DRUG fluorouracil
- RADIATION Intensity modulated radiation therapy
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 68 participants |
| Start Date | 2003-02 |
| Est. Completion | 2016-12 |
| Phase | Phase 2 |
What the finished NCT00057785 record still lists
NCT00057785 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 68 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (49% lower).
The record links to 0 conditions, and to 3 interventions - of which cisplatin is the first listed.
NCT00057785 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00057785 about?
NCT00057785 is a clinical study titled "Radiation Therapy With or Without Chemotherapy in Reducing Mouth Dryness in Patients With Nasopharyngeal Cancer". RATIONALE: Radiation therapy uses high-energy x-rays to damage tumor cells. Giving radiation therapy in different ways may cause less damage to normal tissue, prevent or lessen mouth dryness, and may help patients live more comfortably. Drugs used in chemotherapy use different ways to stop tumor cel...
What is the current status of trial NCT00057785?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 68 participants. The study started on 2003-02. Estimated completion is 2016-12.
What interventions are being tested in trial NCT00057785?
The interventions under investigation include: cisplatin (DRUG), fluorouracil (DRUG), Intensity modulated radiation therapy (RADIATION).
Who is sponsoring clinical trial NCT00057785?
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 NCT00057785's enrollment target sits among peer trials
68 967th of 2000 higher than 1,027 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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