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NCT00075582 · ClinicalTrials.gov registry record · Phase 3
Vincristine, Dactinomycin, and Cyclophosphamide With or Without Radiation Therapy in Treating Patients With Newly Diagnosed Low-Risk Rhabdomyosarcoma
A Phase 3 study, sponsored by Children's Oncology Group.
- Completed
- Registry status
- Phase 3
- Development phase
- 390
- Enrollment target
NCT00075582: Completed Phase 3 study, sponsored by Children's Oncology Group.
NCT00075582 is a Phase 3 study that has completed, run by Children's Oncology Group. The registered enrollment target is 390 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (49% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00075582, a Phase 3 study, has completed, sponsored by Children's Oncology Group.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 390 participants
- Enrollment target
Study Summary
This phase III trial is studying how well combination chemotherapy and radiation therapy work in treating patients with newly diagnosed low-risk rhabdomyosarcoma. Drugs used in chemotherapy, such as vincristine, dactinomycin, and cyclophosphamide, work in different ways to stop tumor cells from dividing so they stop growing or die. Radiation therapy uses high-energy x-rays to damage tumor cells. Combining chemotherapy with radiation therapy may kill more tumor cells. It is not yet known which treatment regimen is more effective in treating low-risk rhabdomyosarcoma.
Primary Outcome
Kaplan Meier estimate of failure free survival at 5 years, where failure free survival is defined as the time to relapse, progression, second malignancy, and death whichever occurs first.
Interventions
- DRUG cyclophosphamide
- PROCEDURE conventional surgery
- RADIATION radiation therapy
- DRUG vincristine sulfate
- DRUG dactinomycin
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 390 participants |
| Start Date | 2004-09-04 |
| Est. Completion | 2021-09-30 |
| Phase | Phase 3 |
What the finished NCT00075582 record still lists
NCT00075582 is an interventional study that assigns participants to a tested intervention. The registered 390 participants enrollment target is mid-sized for trials with a published cap, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (49% lower).
The record links to 0 conditions, and to 5 interventions - of which cyclophosphamide is the first listed.
NCT00075582 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00075582 about?
NCT00075582 is a clinical study titled "Vincristine, Dactinomycin, and Cyclophosphamide With or Without Radiation Therapy in Treating Patients With Newly Diagnosed Low-Risk Rhabdomyosarcoma". This phase III trial is studying how well combination chemotherapy and radiation therapy work in treating patients with newly diagnosed low-risk rhabdomyosarcoma. Drugs used in chemotherapy, such as vincristine, dactinomycin, and cyclophosphamide, work in different ways to stop tumor cells from divi...
What is the current status of trial NCT00075582?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 390 participants. The study started on 2004-09-04. Estimated completion is 2021-09-30.
What interventions are being tested in trial NCT00075582?
The interventions under investigation include: cyclophosphamide (DRUG), conventional surgery (PROCEDURE), radiation therapy (RADIATION), vincristine sulfate (DRUG), dactinomycin (DRUG).
Who is sponsoring clinical trial NCT00075582?
This trial is sponsored by Children's Oncology Group, which has 342 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00075582's enrollment target sits among peer trials
390 968th of 2000 higher than 1,029 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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