A Phase II Study of Hypofractionated Highly Conformal Radiation With Helical Tomotherapy for Extra-Cranial Oligo
Overview
- Phase
- Phase 2
- Intervention
- Not specified
- Conditions
- Kidney Cancer
- Sponsor
- National Institutes of Health Clinical Center (CC)
- Enrollment
- 1
- Locations
- 1
- Primary Endpoint
- 6-month Local Control (i.e., Complete Response, Partial Response, or Stable Disease) at All Treated Sites of Metastatic Disease
- Status
- Terminated
- Last Updated
- 9 years ago
Overview
Brief Summary
RATIONALE: Specialized radiation therapy that delivers a high dose of radiation directly to the tumor may kill more tumor cells and cause less damage to normal tissue.
PURPOSE: This phase II trial is studying how well conformal radiation therapy works in treating patients with metastatic cancer outside the brain.
Detailed Description
OBJECTIVES: Primary * 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. Secondary * 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 these patients. 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 treatment. After completion of study therapy, patients are followed at 1 and 3 months and then every 3 months for up to 1 year.
Investigators
Deborah Citrin, M.D.
Principal Investigator
National Institutes of Health Clinical Center (CC)
Eligibility Criteria
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Outcomes
Primary Outcomes
6-month Local Control (i.e., Complete Response, Partial Response, or Stable Disease) at All Treated Sites of Metastatic Disease
Time Frame: 6 months
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.
Secondary Outcomes
- Number of Participants With Adverse Events(9 months, 11 days)
- Median Time to Local Progression(6-12 months)
- 12 Month Local Control in All Sites of Treatment, and at Each Site of Treatment(12 months)
- Interfraction and Intrafraction Motion With Megavoltage Computed Tomography (CT) Based on Sites of Metastasis(One to three months of followup)
- Pain at Sites of Metastases(One and three months of follow up)
- Tumor Doubling Times During Systemic Treatment Compared Between Tumors Untreated With Radiation (Newly Developed Tumors) and Tumors Which Have Received Radiation Therapy(Baseline and prior to termination of systemic therapy or protocol withdrawal)