A Phase II Trial of Image Guided Preoperative Radiotherapy for Primary Soft Tissue Sarcomas of the Extremity
- 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.
- 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
- To estimate the rates of local failure, local-regional failure, distant failure,
distant disease-free survival, disease-free survival, overall survival, and second
- 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 (MTRS).
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.
Allocation: Non-Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Late radiation morbidity (≥ grade 2 lymphedema, subcutaneous fibrosis, or joint stiffness) at 2 years from the start of radiotherapy as measured by EORTC/RTOG criteria
Late radiation morbidity (≥ grade 2 lymphedema, subcutaneous fibrosis, or joint stiffness) at 2 years from the start of radiotherapy as measured by European Organization for Research and Treatment of Cancer (EORTC)/Radiation Therapy Oncology Group (RTOG) criteria
From start of treatment to 2 years
Dian Wang, MD, PhD
Medical College of Wisconsin
United States: Federal Government
|Roswell Park Cancer Institute||Buffalo, New York 14263|
|Mayo Clinic - Jacksonville||Jacksonville, Florida 32224|
|Mayo Clinic Cancer Center||Rochester, Minnesota 55905|
|CCOP - Christiana Care Health Services||Wilmington, Delaware 19899|
|Medical College of Wisconsin Cancer Center||Milwaukee, Wisconsin 53226|
|Norris Cotton Cancer Center at Dartmouth-Hitchcock Medical Center||Lebanon, New Hampshire 03756-0002|
|University of Florida Shands Cancer Center||Gainesville, Florida 32610-0232|
|William Beaumont Hospital - Royal Oak Campus||Royal Oak, Michigan 48073|
|Massachusetts General Hospital||Boston, Massachusetts 02114-2617|
|H. Lee Moffitt Cancer Center and Research Institute at University of South Florida||Tampa, Florida 33612|
|University of Miami Sylvester Comprehensive Cancer Center - Miami||Miami, Florida 33136|
|Penn State Hershey Cancer Institute at Milton S. Hershey Medical Center||Hershey, Pennsylvania 17033-0850|
|Norris Cotton Cancer Center - North||Saint Johnsbury, Vermont 05819|
|Norton Suburban Hospital||Louisville, Kentucky 40207|