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NCT00321698 · ClinicalTrials.gov registry record · Phase 1
Radiation Therapy and Docetaxel in Treating Patients Who Are Undergoing Surgery for Localized Prostate Cancer
A Phase 1 study, sponsored by OHSU Knight Cancer Institute.
- Terminated
- Registry status
- Phase 1
- Development phase
- 25
- Enrollment target
NCT00321698: Clinical Trial Phase 1 study, sponsored by OHSU Knight Cancer Institute.
NCT00321698 is a Phase 1 study that was terminated before completion, run by OHSU Knight Cancer Institute. The registered enrollment target is 25 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (58% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00321698, a Phase 1 study, was terminated before completion, sponsored by OHSU Knight Cancer Institute.
- TERMINATED
- Registry status
- Phase 1
- Development phase
- 25 participants
- Enrollment target
Study Summary
RATIONALE: Radiation therapy uses high-energy x-rays to kill tumor cells. Drugs used in chemotherapy, such as docetaxel, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving radiation therapy together with chemotherapy before surgery may make the tumor smaller and reduce the amount of normal tissue that needs to be removed. PURPOSE: This phase I/II trial is studying the side effects and best dose of docetaxel when given together with radiation therapy and to see how well they work in treating patients who are undergoing surgery for high-risk localized prostate cancer.
Primary Outcome
Maximal tolerated dose (MTD) of the combination radiation (45 Gy) and docetaxel. The dose of radiation will be fixed at 45 Gy while the dose of docetaxel will be escalated. The starting dose of docetaxel will be 10 mg/m2 and will be escalated in increments of 10 mg/m2 up to a dose of 30 mg/m2 the pre-planned ceiling). MTD will be the dose that is associated with no more than 1 dose limiting toxicity (DLT) up to 6 patients. The DLT will be defined as clinically significant grade 3 non-hematolog
Interventions
- RADIATION Intensity-Modulated Radiation Therapy (IMRT)
- DRUG Docetaxel+IMRT
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 25 participants |
| Start Date | 2006-04-21 |
| Est. Completion | 2023-08-18 |
| Phase | Phase 1 |
Why NCT00321698 stopped before completion
NCT00321698 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 25 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (58% lower).
The record links to 0 conditions, and to 2 interventions - of which Intensity-Modulated Radiation Therapy (IMRT) is the first listed.
NCT00321698 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00321698 about?
NCT00321698 is a clinical study titled "Radiation Therapy and Docetaxel in Treating Patients Who Are Undergoing Surgery for Localized Prostate Cancer". RATIONALE: Radiation therapy uses high-energy x-rays to kill tumor cells. Drugs used in chemotherapy, such as docetaxel, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving radiation therapy together with chemotherapy before...
What is the current status of trial NCT00321698?
This trial is currently terminated. It is a Phase 1 study. The enrollment target is 25 participants. The study started on 2006-04-21. Estimated completion is 2023-08-18.
What interventions are being tested in trial NCT00321698?
The interventions under investigation include: Intensity-Modulated Radiation Therapy (IMRT) (RADIATION), Docetaxel+IMRT (DRUG).
Who is sponsoring clinical trial NCT00321698?
This trial is sponsored by OHSU Knight Cancer Institute, which has 211 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00321698's enrollment target sits among peer trials
25 1495th of 2000 higher than 481 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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