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NCT00924027 · ClinicalTrials.gov registry record · Phase 2
A Study of Patients Receiving High-Dose Rate Brachytherapy
A Phase 2 study of Prostate Cancer and Endometrial Cancer, sponsored by National Cancer Institute (NCI).
- Completed
- Registry status
- Phase 2
- Development phase
- 43
- Enrollment target
- 1
- Study location
NCT00924027: Completed Phase 2 study of Prostate Cancer and Endometrial Cancer, sponsored by National Cancer Institute (NCI).
NCT00924027 is a Phase 2 study of Prostate Cancer and Endometrial Cancer that has completed, run by National Cancer Institute (NCI). The registered enrollment target is 43 participants, below the 608-participant average among 735 other Prostate Cancer trials with a reported enrollment target (93% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00924027, a Phase 2 study of Prostate Cancer and Endometrial Cancer, has completed, sponsored by National Cancer Institute (NCI).
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 43 participants
- Enrollment target
- 1
- Study location
Study Summary
Background: * One standard way of giving radiation is to combine external beam treatments with internal brachytherapy treatments, which involve short-range radiation therapy that gives a high dose of radiation directly to a cancer or to the area where cancer cells were removed. * Brachytherapy is done by placing hollow implant device(s) into the area to be treated and then moving a radiation source into each. The type of device depends on the type of cancer and the site to be treated. These devices can range from hollow applicators and needles to balloon-like equipment. Objectives: * To evaluate the quality of the brachytherapy procedure at the National Institutes of Health Radiation Oncology Branch. Eligibility: * Patients with cancer who could potentially benefit from high-dose brachytherapy as part of their treatment. Design: * In conjunction with their existing treatment, patients will be treated with high-dose brachytherapy as determined appropriate for their particular type of cancer and cancer history. * Each treatment will take place in the Radiation Oncology Clinic. * If the patient does not have implant devices, the clinic staff will insert them and check their placement through a computed tomography (CT) scan. * The calculations to determine the appropriate brachytherapy dose will take a few hours; the brachytherapy treatment itself will take between 10 and 30 minutes. * The number of brachytherapy treatments will vary according to the individual needs and requirements of each type of cancer and each patient. * Patients will return to the Radiation Oncology Clinic for follow-up visits at 1, 3, 6, 9, and 12 months after the completion of radiation therapy. Follow-up evaluations will include a medical history and physical examination, assessment of any side effects of radiation therapy, and a repeat of any imaging (i.e., CT, magnetic resonance imaging (MRI), X-ray) that was done at baseline to evaluate the tumor response.
Primary Outcome
An implant is adequate if 90% of the Gross Tumor Volume (GTV) receives 90% of the dose prescribed and 80% of the Clinical Tumor Volume (CTV) receives 85% of the prescribed dose. An implant is inadequate if the above criteria is not met. A GTV only applies to certain disease sites such as gynecologic cancer that have not been removed by surgery and CTV applies to prostate or gynecologic cancer that have been removed surgically.
Conditions Studied
Interventions
- DIAGNOSTIC_TEST MRI
- DIAGNOSTIC_TEST CT
- DIAGNOSTIC_TEST PET Scan
- RADIATION High Dose Radiation (HDR) Brachytherapy
Study Locations (1)
Maryland
- National Institutes of Health Clinical Center - Bethesda
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 43 participants |
| Start Date | 2009-04-14 |
| Est. Completion | 2025-07-24 |
| Phase | Phase 2 |
What the finished NCT00924027 record still lists
NCT00924027 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 43 participants, a relatively small participant target, below the 608-participant average among 735 other Prostate Cancer trials with a reported enrollment target (93% lower).
The record links to 5 conditions, with Prostate Cancer appearing as the primary indexed condition, and to 4 interventions - of which MRI is the first listed.
NCT00924027 reports a single indexed study location in Maryland.
Frequently Asked Questions
What is clinical trial NCT00924027 about?
NCT00924027 is a clinical study titled "A Study of Patients Receiving High-Dose Rate Brachytherapy". Background: * One standard way of giving radiation is to combine external beam treatments with internal brachytherapy treatments, which involve short-range radiation therapy that gives a high dose of radiation directly to a cancer or to the area where cancer cells were removed. * Brachytherapy is d...
What is the current status of trial NCT00924027?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 43 participants. The study started on 2009-04-14. Estimated completion is 2025-07-24.
What conditions does trial NCT00924027 study?
This clinical trial studies the following conditions: Prostate Cancer, Endometrial Cancer, Cervical Cancer, Esophageal Cancer, Biliary Cancer.
What interventions are being tested in trial NCT00924027?
The interventions under investigation include: MRI (DIAGNOSTIC_TEST), CT (DIAGNOSTIC_TEST), PET Scan (DIAGNOSTIC_TEST), High Dose Radiation (HDR) Brachytherapy (RADIATION).
Who is sponsoring clinical trial NCT00924027?
This trial is sponsored by National Cancer Institute (NCI), which has 3,257 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT00924027 being conducted?
This trial has 1 study location across Maryland. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT00924027's enrollment target sits among peer trials
43 516th of 735 higher than 217 of 735 other Prostate Cancer trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Prostate Cancer 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.
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