NCT00550654

Conformal Radiation Therapy in Treating Patients With Metastatic Cancer Outside the Brain

A Phase II Study of Hypofractionated Highly Conformal Radiation With Helical Tomotherapy for Extra-Cranial Oligo

• Status: Terminated
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 1 (actual)
• Sponsor: National Institutes of Health Clinical Center (CC) · NIH
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Kidney Cancer
• Melanoma (Skin)
• Metastatic Cancer
• Ovarian Cancer
• Sarcoma
• Unspecified Adult Solid Tumor, Protocol Specific

Interventions

Type	Name	Description
OTHER	questionnaire administration	Patients complete a pain assessment questionnaire, Brief Pain Inventory at baseline and at 1 and 3 months after treatment.
RADIATION	3-dimensional conformal radiation therapy	Conformal radiation therapy improves the ability to spare normal tissues.
RADIATION	hypofractionated radiation therapy	Hypofractionated radiation therapy is delivered to maximize pain relief while minimizing patient impact if life expectancy is short.
RADIATION	image-guided radiation therapy	Image guided radiation therapy targets the specific site of disease.
RADIATION	tomotherapy	Tomotherapy is a delivery method which provides megavoltage computed tomography (CT) localization and may provide superior conformality and localization compared to other dynamic intensity modulated radiation therapy techniques.

Timeline

• Start date: 2007-10-01
• Primary completion: 2010-05-01
• Completion: 2010-05-01
• First posted: 2007-10-30
• Last updated: 2017-01-13
• Results posted: 2012-09-18

Locations

1 site across 1 country: United States