A Pilot Study of High Dose Rate Brachytherapy in The Radiation Oncology Branch
Overview
- Phase
- Phase 2
- Intervention
- Not specified
- Conditions
- Cervical Cancer
- Sponsor
- National Cancer Institute (NCI)
- Enrollment
- 42
- Locations
- 1
- Primary Endpoint
- Number of Participants Who Had Adequate High-Quality Brachytherapy Implants Reported Per Strata (Four Body Sites) and Combined Overall
- Status
- Completed
- Last Updated
- 7 months ago
Overview
Brief 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 s 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 followup visits at 1, 3, 6, 9, and 12 months after the completion of radiation therapy. Followup 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, MRI, X-ray) that was done at baseline to evaluate the tumor response.
Detailed Description
BACKGROUND: * High dose rate brachytherapy (HDR) is a challenging technique utilized in many malignancies in order to deliver a high dose of radiation therapy to a tumor in a conformal fashion with a rapid dose fall-off with the objective of sparing normal surrounding tissue * HDR therapy has been targeted to particular subsites as an integral part of either definitive management or palliation for malignancy-related symptoms. OBJECTIVES: * The primary objective is to determine the quality of high dose rate brachytherapy implants performed in the radiation oncology branch. An implant will be adequate if 90% of the GTV receives 90% of the dose prescribed and 80% of the CTV receives 85% of the prescribed dose. An implant will be inadequate if the above dose limitations are not met. * To evaluate local control and late toxicity rates following brachytherapy at the NCI ROB * To increase the flow of oncology participants requiring brachytherapy to the NCI ROB, as these participants lend themselves to special study and have unique educational value for the purpose of educating nurses, medical students, residents, physicists, clinical fellows, and physicians. ELIGIBILITY: -Participants with cancer who could potentially benefit from the use of high dose rate brachytherapy as a component of their treatment. DESIGN: * Participants will undergo appropriate work-up and clinical evaluation to determine if high-dose brachytherapy would be beneficial in either primary treatment or palliation of their disease. Participants will be treated with high-dose brachytherapy appropriately sequenced with other modalities in their treatment regimen. This treatment will be administered in accordance with standard radiation oncology practice and per the ABS (American Brachytherapy Society) guidelines. * The participant s disease status and toxicity outcomes will be documented for a 12-month period at 3-months intervals.
Investigators
Eligibility Criteria
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Outcomes
Primary Outcomes
Number of Participants Who Had Adequate High-Quality Brachytherapy Implants Reported Per Strata (Four Body Sites) and Combined Overall
Time Frame: All participants were assessed 1 week after last dose of high dose radiation (HDR) brachytherapy, an average of 1 week (no range).
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.
Secondary Outcomes
- Number of Prostate Participants With Local Control(Assessed at 12 months after radiation)
- Number of Participants With Local Control Reported Per Strata (Body Sites) and Combined Overall(Assessed at 12 months after radiation)
- Number of Grades 0-5 Late Toxicity Reported Per Strata (Body Sites) and Combined Overall(Date treatment consent signed to date off study, approximately 159 months and 21 days.)
- Number of Participants Accrued Who Received Brachytherapy Each Year(Approximately 16 years)