Sarcoma Clinical Trial
Official title:
A Phase II Trial of Image Guided Preoperative Radiotherapy for Primary Soft Tissue Sarcomas of the Extremity
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.
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.
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