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NCT00004054 · ClinicalTrials.gov registry record · Phase 3
Hormone Therapy Plus Radiation Therapy With or Without Combination Chemotherapy in Treating Patients With Prostate Cancer
A Phase 3 study, sponsored by Radiation Therapy Oncology Group.
- Completed
- Registry status
- Phase 3
- Development phase
- 397
- Enrollment target
NCT00004054: Completed Phase 3 study, sponsored by Radiation Therapy Oncology Group.
NCT00004054 is a Phase 3 study that has completed, run by Radiation Therapy Oncology Group. The registered enrollment target is 397 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
NCT00004054, a Phase 3 study, has completed, sponsored by Radiation Therapy Oncology Group.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 397 participants
- Enrollment target
Study Summary
RATIONALE: Hormones can stimulate the production of prostate cancer cells. Hormone therapy may fight prostate cancer by reducing the production of androgens. Radiation therapy uses high-energy 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. It is not yet known whether hormone therapy plus radiation therapy is more effective with or without combination chemotherapy for prostate cancer. PURPOSE: Randomized phase III trial to compare the effectiveness of hormone therapy plus radiation therapy with or without combination chemotherapy in treating patients who have prostate cancer.
Primary Outcome
Survival time is defined as time from randomization to date of death from any cause and is estimated by the Kaplan-Meier method. Patients last known to be alive are censored at date of last contact. This analysis was planned to occur when all patients had been potentially followed for 5 years.
Interventions
- DRUG paclitaxel
- DRUG etoposide
- DRUG bicalutamide
- DRUG flutamide
- DRUG estramustine phosphate sodium
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 397 participants |
| Start Date | 2000-01 |
| Est. Completion | 2013-11 |
| Phase | Phase 3 |
What the finished NCT00004054 record still lists
NCT00004054 is an interventional study that assigns participants to a tested intervention. The registered 397 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 paclitaxel is the first listed.
NCT00004054 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00004054 about?
NCT00004054 is a clinical study titled "Hormone Therapy Plus Radiation Therapy With or Without Combination Chemotherapy in Treating Patients With Prostate Cancer". RATIONALE: Hormones can stimulate the production of prostate cancer cells. Hormone therapy may fight prostate cancer by reducing the production of androgens. Radiation therapy uses high-energy x-rays to damage tumor cells. Drugs used in chemotherapy use different ways to stop tumor cells from dividi...
What is the current status of trial NCT00004054?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 397 participants. The study started on 2000-01. Estimated completion is 2013-11.
What interventions are being tested in trial NCT00004054?
The interventions under investigation include: paclitaxel (DRUG), etoposide (DRUG), bicalutamide (DRUG), flutamide (DRUG), estramustine phosphate sodium (DRUG).
Who is sponsoring clinical trial NCT00004054?
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 NCT00004054's enrollment target sits among peer trials
397 964th of 2000 higher than 1,037 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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