HDR Brachytherapy for Prostate Cancer

Recruiting in Palo Alto (17 mi)

+1 other location

Deborah E. Citrin, M.D. | Center for ...

Overseen byDeborah Citrin, MD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Waitlist Available

Sponsor: National Cancer Institute (NCI)

No Placebo Group

Prior Safety Data

Approved in 3 Jurisdictions

Trial Summary

What is the purpose of this trial?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.

Eligibility Criteria

This trial is for adults over 18 with various cancers (like endometrial, cervical, esophageal, biliary, prostate) who may benefit from high-dose brachytherapy. Participants must be in relatively good health and have a primary oncologist to collaborate on their care. They should agree to use birth control if they can have children.

Inclusion Criteria

I have cervical cancer.

I have lung cancer.

My cancer has returned at the top part of my vagina.

+18 more

Exclusion Criteria

Pregnant or breast-feeding females

I am able to follow the treatment plan as directed.

I have abnormal bleeding times or am on blood thinners.

+6 more

Participant Groups

The study tests high-dose rate brachytherapy—a type of internal radiation therapy—on patients with specific cancers. It involves placing devices inside or near the tumor area and delivering concentrated radiation directly to the cancer cells.

1Treatment groups

Experimental Treatment

Group I: 1/Radiation TherapyExperimental Treatment4 Interventions

Radiation therapy given as high dose radiation (HDR) Brachytherapy.

HDR Brachytherapy is already approved in European Union, United States, Canada for the following indications:

🇪🇺 Approved in European Union as HDR Brachytherapy for: