Spots Global Cancer Trial Database for Image-Guided Radiation Therapy in Treating Patients With Primary Soft Tissue Sarcoma of the Shoulder, Arm, Hip, or Leg
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Trial Identification
Brief Title: Image-Guided Radiation Therapy in Treating Patients With Primary Soft Tissue Sarcoma of the Shoulder, Arm, Hip, or Leg
Official Title: A Phase II Trial of Image Guided Preoperative Radiotherapy for Primary Soft Tissue Sarcomas of the Extremity
Study ID: NCT00589121
Study Description
Brief Summary: RATIONALE: Image-guided radiation therapy uses high-energy x-rays to kill tumor cells. Specialized radiation therapy that delivers a lower 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 the side effects and how well image-guided radiation therapy works in treating patients with primary soft tissue sarcoma of the shoulder, arm, hip, or leg.
Detailed Description: OBJECTIVES: Primary * To determine the effect of reduced radiation volume using image-guided radiotherapy (IGRT) on lymphedema ≥ grade 2, subcutaneous fibrosis, and joint stiffness at 2 years in patients with primary soft tissue sarcoma of the extremity. Secondary * To estimate the rates of other grade 3-5 adverse events as measured by Common Toxicity Criteria for Adverse Effects (CTCAE) v3.0. * To determine the pattern of first failure, including local failure (in-field, marginal, and outside-field failure), regional failure, distant failure, and death without disease progression. * To estimate the rates of local failure, local-regional failure, distant failure, distant disease-free survival, disease-free survival, overall survival, and second primary tumor. * To estimate the rate of wound complications. * To correlate the degree of late radiation morbidity (defined as any lymphedema, subcutaneous fibrosis, or joint stiffness) at 2 years with scores on the clinical measure, Musculoskeletal Tumor Rating Scale (MSTS). OUTLINE: This is a multicenter study. * Neoadjuvant radiotherapy: Patients are assigned to 1 of 2 treatment groups (group 1 closed to accrual as of 01/08/10). * Group 1 (closed to accrual as of 01/08/10): Patients undergo 3-D conformal radiotherapy (3D-CRT) or intensity-modulated therapy (IMRT) once daily, 5 days a week, for 4½-5 weeks. Patients also receive up to 6 courses of neoadjuvant, adjuvant, concurrent, or interdigitated chemotherapy. * Group 2: Patients undergo 3D-CRT or IMRT once daily, 5 days a week, for 5 weeks. * Surgery: At 4-8 weeks after completion of neoadjuvant radiotherapy, patients undergo surgical resection of the tumor. Patients with positive tumor margins (residual tumor) undergo intraoperative radiotherapy boost or proceed to adjuvant radiotherapy within 2 weeks after surgery. * Adjuvant radiotherapy: Patients undergo either external-beam radiotherapy (EBRT) once daily for 8 fractions or brachytherapy. After completion of study treatment, patients are followed at least every 3 months for 2 years, every 6 months for 3 years, and then annually thereafter.
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
CCOP - Christiana Care Health Services, Newark, Delaware, United States
University of Florida Shands Cancer Center, Gainesville, Florida, United States
Mayo Clinic - Jacksonville, Jacksonville, Florida, United States
University of Miami Sylvester Comprehensive Cancer Center - Miami, Miami, Florida, United States
H. Lee Moffitt Cancer Center and Research Institute at University of South Florida, Tampa, Florida, United States
Norton Suburban Hospital, Louisville, Kentucky, United States
Massachusetts General Hospital, Boston, Massachusetts, United States
William Beaumont Hospital - Royal Oak Campus, Royal Oak, Michigan, United States
Mayo Clinic Cancer Center, Rochester, Minnesota, United States
Norris Cotton Cancer Center at Dartmouth-Hitchcock Medical Center, Lebanon, New Hampshire, United States
Roswell Park Cancer Institute, Buffalo, New York, United States
Penn State Hershey Cancer Institute at Milton S. Hershey Medical Center, Hershey, Pennsylvania, United States
Norris Cotton Cancer Center - North, Saint Johnsbury, Vermont, United States
Medical College of Wisconsin Cancer Center, Milwaukee, Wisconsin, United States
Cross Cancer Institute at University of Alberta, Edmonton, Alberta, Canada
London Regional Cancer Program at London Health Sciences Centre, London, Ontario, Canada
McGill Cancer Centre at McGill University, Montreal, Quebec, Canada
Contact Details
Name: Dian Wang, MD, PhD
Affiliation: Medical College of Wisconsin
Role: PRINCIPAL_INVESTIGATOR
Name: Scott Okuno, MD
Affiliation: Mayo Clinic
Role: STUDY_CHAIR
Name: Burton L. Eisenberg, MD
Affiliation: Norris Cotton Cancer Center
Role: STUDY_CHAIR
Name: John M. Kane, MD
Affiliation: Roswell Park Cancer Institute
Role: STUDY_CHAIR
Name: David G. Kirsch, MD, PhD
Affiliation: Duke Cancer Institute
Role: STUDY_CHAIR
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