A Natural History Study of Patients Receiving High-Dose Rate Brachytherapy
- 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.
- To evaluate the quality of the brachytherapy procedure at the National Institutes of Health s Radiation Oncology Branch.
- Patients with cancer who could potentially benefit from high-dose brachytherapy as part of their treatment.
- 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.
|Study Design:||Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||A Natural History Study of Patients Receiving High Dose Rate Brachytherapy|
- 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 prescribed dose.
- To evaluate local control and late toxicity rates following brachytherapy at NCI ROB. Increase the flow of oncology patients requiring brachytherapy to the NCI ROB, as these patients lend themselves to special study and have unique educational v...
|Study Start Date:||March 2009|
|Estimated Study Completion Date:||November 2014|
|Estimated Primary Completion Date:||November 2014 (Final data collection date for primary outcome measure)|
- 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.
- 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 patients requiring brachytherapy to the NCI ROB, as these patients lend themselves to special study and have unique educational value for the purpose of educating nurses, medical students, residents, physicists, clinical fellows, and physicians.
-Patients with cancer who could potentially benefit from the use of high dose rate brachytherapy as a component of their treatment.
- Patients 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. Patients 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 natural history of the patient s disease status and toxicity outcomes will be documented for a 12-month period at 3-months intervals.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00924027
|Contact: Sharon L Smith, R.N.||(301) email@example.com|
|Contact: Aradhana Kaushal, M.D.||(301) firstname.lastname@example.org|
|United States, Maryland|
|National Institutes of Health Clinical Center, 9000 Rockville Pike||Recruiting|
|Bethesda, Maryland, United States, 20892|
|Contact: For more information at the NIH Clinical Center contact National Cancer Institute Referral Office (888) NCI-1937|
|Principal Investigator:||Aradhana Kaushal, M.D.||National Cancer Institute (NCI)|