A Phase II Study of Hypofractionated Highly Conformal Radiation With Helical Tomotherapy for Extra-Cranial Oligo
- To evaluate local control (defined as absence of local progression) at all treated
sites of metastatic disease in patients with extracranial oligometastases treated with
ablative doses of highly conformal radiotherapy delivered with helical tomotherapy.
- To evaluate local control at each treated site of metastatic disease in these patients.
- To determine median time to local progression in patients treated with this regimen.
- To evaluate interfraction and intrafraction motion with megavoltage computed tomography
(CT) imaging based on site of metastasis in these patients.
- To compare tumor growth during systemic therapy in tumors treated with targeted
radiotherapy vs newly developed tumors that have not been treated with radiotherapy.
- To evaluate if treatment with hypofractionated highly conformal radiotherapy with
helical tomotherapy can improve pain scores and decrease the need for analgesia in
OUTLINE: Patients are stratified according to histology (renal cell carcinoma vs melanoma vs
sarcoma vs other histologies).
Patients undergo hypofractionated highly conformal radiotherapy with helical tomotherapy
once every other day over 5 days for a total of 3 fractions. Patients undergo megavoltage
imaging before and after each fraction to verify the positioning of each target lesion.
Patients complete a pain assessment questionnaire at baseline and at 1 and 3 months after
After completion of study therapy, patients are followed at 1 and 3 months and then every 3
months for up to 1 year.
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
6-month Local Control (i.e., Complete Response, Partial Response, or Stable Disease) at All Treated Sites of Metastatic Disease
Local control (e.g. absence of local progression) is defined as Complete response (CR), partial response (PR) or stable disease (SD) of the treated site(s). Complete response is the disappearance of the target lesion. Partial response is a >/= 50% decrease in maximal dimension compared to pretreatment imaging. Stable disease does not qualify for CR, PR, or progression.Progression is an interval increase in the maximal dimension of the target lesion.
Deborah E. Citrin, MD
NCI - Radiation Oncology Branch; ROB
United States: Federal Government
|Warren Grant Magnuson Clinical Center - NCI Clinical Trials Referral Office||Bethesda, Maryland 20892-1182|