NCT00924027

A Study of Patients Receiving High-Dose Rate Brachytherapy

A Pilot Study of High Dose Rate Brachytherapy in The Radiation Oncology Branch

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 43 (actual)
• Sponsor: National Cancer Institute (NCI) · NIH
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

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 Gross Tumor Volume (GTV) 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 National Cancer Institute (NCI) Radiation Oncology Branch (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 participants disease status and toxicity outcomes will be documented for a 12-month period at 3-months intervals.

Conditions

• Cervical Cancer
• Endometrial Cancer
• Esophageal Cancer
• Prostate Cancer
• Biliary Cancer

Interventions

Type	Name	Description
RADIATION	High Dose Radiation (HDR) Brachytherapy	Brachytherapy, the placement of a radioactive source close to a tumor, is a well-established part of the treatment of many malignancies, both for palliative and definitive applications. High dose brachytherapy is useful in many malignancies in order to deliver a high dose of radiation therapy to tumor in a conformal fashion with a rapid dose fall-off with the objective of sparing normal surrounding tissue.
DIAGNOSTIC_TEST	MRI	When deemed necessary.
DIAGNOSTIC_TEST	CT	Obtained based on the sites of target, as clinical situation dictates and at each follow-up to determine local control.
DIAGNOSTIC_TEST	PET Scan	When deemed necessary.

Timeline

• Start date: 2009-04-14
• Primary completion: 2024-05-28
• Completion: 2025-07-24
• First posted: 2009-06-18
• Last updated: 2025-09-05
• Results posted: 2024-09-24

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study