A Natural History Study of Patients Receiving High Dose Rate Brachytherapy
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 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.
ELIGIBILITY:
-Patients with cancer who could potentially benefit from the use of high dose rate
brachytherapy as a component of their treatment.
DESIGN:
- 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.
Interventional
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
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.
Aradhana Kaushal, M.D.
Principal Investigator
National Cancer Institute (NCI)
United States: Federal Government
090100
NCT00924027
March 2009
November 2013
Name | Location |
---|---|
National Institutes of Health Clinical Center, 9000 Rockville Pike | Bethesda, Maryland 20892 |