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NCT00003930 · ClinicalTrials.gov registry record · Phase 1
Radiation Therapy and Combination Chemotherapy in Treating Patients With Stage II or Stage III Bladder Cancer
A Phase 1 study, sponsored by Radiation Therapy Oncology Group.
- Completed
- Registry status
- Phase 1
- Development phase
- 84
- Enrollment target
NCT00003930: Completed Phase 1 study, sponsored by Radiation Therapy Oncology Group.
NCT00003930 is a Phase 1 study that has completed, run by Radiation Therapy Oncology Group. The registered enrollment target is 84 participants, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (40% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00003930, a Phase 1 study, has completed, sponsored by Radiation Therapy Oncology Group.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 84 participants
- Enrollment target
Study Summary
RATIONALE: Radiation therapy uses x-rays to damage tumor cells. Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining radiation therapy with chemotherapy and surgery may kill more tumor cells. PURPOSE: Phase I/II trial to study the effectiveness of radiation therapy plus combination chemotherapy in treating patients who have stage II or stage III bladder cancer that can be removed by surgery.
Primary Outcome
Completion and safety of induction chemo-radiotherapy (cisplatin, paclitaxel and irradiation \[TCI\]) followed by definitive local therapy of either radical cystectomy (for patients for whom the initial tumor is not a complete response) or consolidation TCI (for patients for whom the initial tumor has cleared), followed by four cycles of outpatient adjuvant gemcitabine-cisplatin chemotherapy.
Interventions
- DRUG cisplatin
- DRUG paclitaxel
- PROCEDURE conventional surgery
- RADIATION radiation therapy
- DRUG gemcitabine hydrochloride
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 84 participants |
| Start Date | 1999-09 |
| Est. Completion | 2013-11 |
| Phase | Phase 1 |
What the finished NCT00003930 record still lists
NCT00003930 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 84 participants, a relatively small participant target, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (40% higher).
The record links to 0 conditions, and to 5 interventions - of which cisplatin is the first listed.
NCT00003930 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00003930 about?
NCT00003930 is a clinical study titled "Radiation Therapy and Combination Chemotherapy in Treating Patients With Stage II or Stage III Bladder Cancer". RATIONALE: Radiation therapy uses x-rays to damage tumor cells. Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining radiation therapy with chemotherapy and surgery may kill more tumor cells. PURPOSE: Phase I/II trial to study the ef...
What is the current status of trial NCT00003930?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 84 participants. The study started on 1999-09. Estimated completion is 2013-11.
What interventions are being tested in trial NCT00003930?
The interventions under investigation include: cisplatin (DRUG), paclitaxel (DRUG), conventional surgery (PROCEDURE), radiation therapy (RADIATION), gemcitabine hydrochloride (DRUG).
Who is sponsoring clinical trial NCT00003930?
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 NCT00003930's enrollment target sits among peer trials
84 659th of 2000 higher than 1,336 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 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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