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NCT00214422 · ClinicalTrials.gov registry record · Early Phase 1
Intensity Modulated Radiation Therapy for Prostate Cancer
A Early Phase 1 study, sponsored by National Cancer Institute (NCI).
- Completed
- Registry status
- Early Phase 1
- Development phase
- 19
- Enrollment target
NCT00214422: Completed Early Phase 1 study, sponsored by National Cancer Institute (NCI).
NCT00214422 is a Early Phase 1 study that has completed, run by National Cancer Institute (NCI). The registered enrollment target is 19 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00214422, a Early Phase 1 study, has completed, sponsored by National Cancer Institute (NCI).
- COMPLETED
- Registry status
- Early Phase 1
- Development phase
- 19 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 primary objective of the first portion of this study is to assess the feasibility of using Intensity-modulated radiation therapy (IMRT) to treat the at-risk lymph nodes in prostate cancer. Also, if feasible, we hope optimize this technique with experience. ELIGIBILITY: -This is a study of image guided, targeted radiation therapy in patients with high risk of nodal metastases from prostate cancer. Patients with prostate cancer who have more than 15% risk of lymph node (as defined by the Partin tables) metastasis will be eligible for this study. DESIGN: * On the first 10 patients, we will perform approximately 5 computed tomography (CT) simulations throughout the course of their therapy. On each simulation, the initial treatment plan will be re-run. The dose-volume data from target and normal tissues will then be re-analyzed. From this analysis we will be better able to determine the size of margins needed to account for organ motion and changes such as varying amounts of gas in the bowel and fluid in the bladder. To the best of our knowledge, no such analyses have been published. * If the initial part of this trial is feasible, we will proceed to a phase I dose escalation trial of radiation to the at-risk lymph nodes. The primary statistical objective of the phase I portion of this study is to estimate the Maximum Tolerated Dose (MTD) of external beam radiation based on evaluating acute toxicity. The study will be conducted with a dose-escalation design with 3 patients in each dose cohort. If fewer than 2 of 3 patients experience an acute dose limiting toxicity (DLT) than patients wi
Interventions
- RADIATION Radiation
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 19 participants |
| Start Date | 2005-09-19 |
| Est. Completion | 2018-04-18 |
| Phase | Early Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00214422
The ClinicalTrials.gov registry entry for NCT00214422 describes a study currently listed as completed, categorized as Early Phase 1. The registered enrollment target is 19 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is National Cancer Institute (NCI), which has 3,257 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which Radiation is the first listed.
NCT00214422 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00214422 about?
NCT00214422 is a clinical study titled "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 NCT00214422?
This trial is currently completed. It is a Early Phase 1 study. The enrollment target is 19 participants. The study started on 2005-09-19. Estimated completion is 2018-04-18.
What interventions are being tested in trial NCT00214422?
The interventions under investigation include: Radiation (RADIATION).
Who is sponsoring clinical trial NCT00214422?
This trial is sponsored by National Cancer Institute (NCI), which has 3,257 total clinical trials registered on ClinicalTrials.gov.
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