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.
Additional locations may be listed on ClinicalTrials.gov for NCT00924027.
See trial information on ClinicalTrials.gov for a list of participating sites.
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.
Lead OrganizationNational Cancer Institute
Principal InvestigatorDeborah E. Citrin
