Intensity-Modulated Radiation Therapy in Treating Patients Undergoing Surgery for Stage IB, Stage II, or Stage III Soft Tissue Sarcoma

Study Overview
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Brief Summary
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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. Giving radiation therapy before surgery may make the tumor smaller and reduce the amount of normal tissue that needs to be removed. PURPOSE: This phase II trial is studying the side effects of intensity-modulated radiation therapy and to see how well it works in treating patients undergoing surgery for stage IB, stage II, or stage III soft tissue sarcoma.

Detailed Description
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OBJECTIVES: Primary Estimate the wound complication rate in patients with stage IB-III soft tissue sarcoma (STS) treated with neoadjuvant intensity-modulated radiotherapy (IMRT). Secondary Assess local control rate in patients treated with this regimen. Assess metastatic failure rate in patients treated with this regimen. Assess disease-free survival of patients treated with this regimen. Assess overall survival of patients treated with this regimen. Assess function and general health in these patients using the Musculoskeletal Tumor Society rating scale, Toronto Extremity Salvage Score, and the Short-Form 36. Determine changes in STS gene expression after IMRT by microarray analyses. Correlate, preliminarily, changes in STS gene expression with pathological and clinical outcomes. OUTLINE: Patients undergo intensity-modulated radiotherapy (IMRT) once daily 5 days a week for 5 weeks in the absence of disease progression or unacceptable toxicity. Patients then undergo surgery > 1 month after completion of IMRT. Tumor tissue samples are collected at baseline and at the time of surgery for correlative laboratory studies. Samples are analyzed for gene expression by RNA microarray, real-time polymerase chain reaction, and western blotting. After completion of study treatment, patients are followed periodically for 2 years.

Official Title
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Phase II Study of Preoperative Intensity-Modulated Radiation Therapy for Soft-Tissue Sarcomas

Conditions
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Sarcoma

Intervention / Treatment
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* Genetic: gene expression analysis
* Genetic: polymerase chain reaction
* Genetic: western blotting
* Procedure: neoadjuvant therapy
* Procedure: therapeutic conventional surgery
* Radiation: intensity-modulated radiation therapy


Participation Criteria
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Eligibility Criteria
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DISEASE CHARACTERISTICS: Histologically confirmed soft tissue sarcoma (STS) for which neoadjuvant or adjuvant radiotherapy is considered standard care Stage IB-III disease Primary or locally recurrent disease The following chemotherapy-sensitive STS histologies are excluded: Primitive neuroectodermal tumor Desmoplastic small round cell tumor Synovial sarcoma Myxoid round cell liposarcoma Angiosarcoma No sarcomas for which surgical staging and adjuvant radiotherapy are considered standard care (e.g., uterine sarcomas, including leiomyosarcoma, malignant mixed Müllerian tumors, and endometrial stromal sarcoma) No retroperitoneal STS PATIENT CHARACTERISTICS: ECOG performance status 0-2 Able to complete the self-assessment questionnaires (may use translator service) Willing and able to undergo pre-treatment core needle biopsies Negative pregnancy test No known HIV positivity PRIOR CONCURRENT THERAPY: Prior adjuvant chemotherapy for STS allowed provided patient has locally recurrent disease At least 1 year since prior adjuvant chemotherapy No prior radiotherapy to the site of present STS No other concurrent cytotoxic chemotherapy, targeted therapy, or investigational agents

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Arm 1<br>pre-operative radiation + surgery PTV will receive a total dose of 50 Gy in 25 fractions, 2 Gy per fraction, 5 fractions per week, over approximately 5 weeks. Concurrently, the GTV2, if present, will receive 54 Gy in 25 fraction. Dose will be prescribed to the isodose volume that encompasses the PTV. All patients will be treated by 6 MV photon beam. | Genetic: gene expression analysis<br> <br> Genetic: polymerase chain reaction<br> <br> Genetic: western blotting<br> <br> Procedure: neoadjuvant therapy<br> <br> Procedure: therapeutic conventional surgery<br> <br> Radiation: intensity-modulated radiation therapy<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Wound Complication Rate | Major wound complications up to 4 months post surgery include: Complications requiring a secondary operation under general or regional anesthesia for wound care. Seroma aspiration. Drain placement. Minor wound debridement and wound care. Readmission for wound care such as intravenous antibiotics. Persistent wound deep packing or wound vacuum assisted closure for greater than 120 days. | 1 year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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recurrent adult soft tissue sarcoma, stage I adult soft tissue sarcoma, stage II adult soft tissue sarcoma, stage III adult soft tissue sarcoma, adult alveolar soft-part sarcoma, adult epithelioid sarcoma, adult extraskeletal chondrosarcoma, adult extraskeletal osteosarcoma, adult fibrosarcoma, adult malignant fibrous histiocytoma, adult malignant hemangiopericytoma, adult malignant mesenchymoma, adult neurofibrosarcoma, adult rhabdomyosarcoma, dermatofibrosarcoma protuberans