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NCT00124917 · ClinicalTrials.gov registry record · Phase 1
Phase I Study of Intensity Modulated Radiation Therapy for Prostate Cancer
A Phase 1 study, sponsored by National Cancer Institute (NCI).
- Terminated
- Registry status
- Phase 1
- Development phase
- 6
- Enrollment target
NCT00124917: Clinical Trial Phase 1 study, sponsored by National Cancer Institute (NCI).
NCT00124917 is a Phase 1 study that was terminated before completion, run by National Cancer Institute (NCI). The registered enrollment target is 6 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (90% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00124917, a Phase 1 study, was terminated before completion, sponsored by National Cancer Institute (NCI).
- TERMINATED
- Registry status
- Phase 1
- Development phase
- 6 participants
- Enrollment target
Study Summary
BACKGROUND: -This study represents a progression from findings in four previous National Cancer Institute (NCI) Radiation Oncology Branch (ROB) protocols (02-C-0167A, 02-C-0207E, 03-C-0190B, 04-C-0171). In these previous works we have begun to develop techniques to obtain magnetic resonance (MR) biological images and co-register tissue in prostate cancer patients. OBJECTIVES: -The scientific objective of this protocol is to determine the maximum tolerated dose (MTD) of external beam radiation to regions of interest within the prostate based acute toxicity. Secondary objectives of this study are to relate patterns in gene and protein expression to response and toxicity and to evaluate the frequency of late term toxicity. ELIGIBILITY: -Patients with prostate cancer without evidence of metastasis will be eligible for this study. DESIGN: * This phase I trial will use intensity modulated radiation therapy (IMRT) to deliver escalating doses of external beam radiation to regions of histologically confirmed prostate cancer. The study will be conducted using a standard 3-6 dose-escalation with an initial 3 patients in each dose cohort and the potential expansion of the cohort to 6 patients. * Anatomic magnetic resonance imaging (MRI) and magnetic resonance (MR) biological images, such as magnetic resonance spectroscopy (MRS), will be obtained. Tissue will be acquired from sites of interest, with biopsy locations precisely translated (co-registered) to an MR image of reference. Tissue samples will be processed for complementary deoxyribonucleic acid (cDNA) microarray testing and stored for future analysis in the Radiation Oncology Branch, NCI. A gold seed will be left at the biopsy site as a fiducial marker to direct future radiation therapy. If necessary, additional fiducial markers will be placed for target localization during treatment. * Once MR guided biopsies are obtained and fiducial markers placed, the patient will undergo a standard computed tomography (CT) s
Primary Outcome
Maximum tolerated dose is defined as the dose level immediately below the dose level at which 2 or more in a cohort of either 3 or 6 patients experienced a dose limiting toxicity attributed to radiation therapy.
Interventions
- RADIATION Radiation
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 6 participants |
| Start Date | 2005-07-21 |
| Est. Completion | 2017-05-09 |
| Phase | Phase 1 |
Why NCT00124917 stopped before completion
NCT00124917 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 6 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (90% lower).
The record links to 0 conditions, and to 1 intervention - of which Radiation is the first listed.
NCT00124917 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00124917 about?
NCT00124917 is a clinical study titled "Phase I Study of Intensity Modulated Radiation Therapy for Prostate Cancer". BACKGROUND: -This study represents a progression from findings in four previous National Cancer Institute (NCI) Radiation Oncology Branch (ROB) protocols (02-C-0167A, 02-C-0207E, 03-C-0190B, 04-C-0171). In these previous works we have begun to develop techniques to obtain magnetic resonance (MR) bi...
What is the current status of trial NCT00124917?
This trial is currently terminated. It is a Phase 1 study. The enrollment target is 6 participants. The study started on 2005-07-21. Estimated completion is 2017-05-09.
What interventions are being tested in trial NCT00124917?
The interventions under investigation include: Radiation (RADIATION).
Who is sponsoring clinical trial NCT00124917?
This trial is sponsored by National Cancer Institute (NCI), which has 3,257 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00124917's enrollment target sits among peer trials
6 1974th of 2000 higher than 12 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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