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| RTOG 0630 |
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| Title: |
A Phase II Trial of Image Guided Preoperative Radiotherapy for Primary Soft Tissue Sarcomas of the Extremity |
| Eligibility: |
For all patients: Histologically proven primary soft tissue sarcoma of the upper extremity (including shoulder) or lower extremity (including hip); extraskeletal myxoid chondoscarcoma is eligible. Patients with sarcomas of the head, neck, intra-abdominal or retroperitoneal region or body wall, hand or feet or with a sarcoma > 32 cm in any direction are ineligible. No histopathology demonstrating rhabdomyosarcoma, extraosseous primitive neuroectodermal tumor (PNET) soft tissue Ewing's sarcoma, osteosarcoma, Kaposi's sarcoma, angiosarcoma, aggressive fibromatosis (desmoid tumor), or dermatofibrosarcoma protuberans or chondrosarcoma. A biopsy must be done within 8 weeks prior to registration. If the patient refuses an incisional biopsy, core biopsies are required for histological diagnosis. No lymph node or distant metastases, based upon the diagnostic workup specified. Evaluation by a surgeon who specializes in soft tissue sarcoma within 8 weeks prior to registration; the patient's tumor must be surgically resectable, and the surgeon must feel that limb preservation surgery alone would not provide adequate local control. Zubrod Performance Status 0-1; Age > 18; For females of childbearing potential, a serum pregnancy test within 2 weeks prior to registration; Patients must provide study-specific informed consent prior to study entry, which includes mandatory submission of tissue for pathology central review. Patients with recurrent tumor following previous potentially curative therapy are excluded. No patients that undergo excisional biopsy in which the majority of the tumor (> 50%) is removed. No prior invasive malignancy. No prior radiotherapy to the region of the study cancer that would result in overlap of radiation therapy fields for current sarcoma. Pregnant females or women of childbearing potential and men who are sexually active and not willing/able to use medically acceptable forms of contraception are ineligible.
For Cohort A patients: Evaluation by a medical oncologist within 8 weeks prior to registration; adequate bone marrow, hepatic, and renal function as defined in the protocol. Left ventricular fraction (LVEF) > 50% (by MUGA or Echo) within 4 weeks prior to registration; patients with severe, active co-morbidity as defined in the protocol are ineligible.
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Preoperative IGRT
(3D-CRT or IMRT)
Surgery
Post-Op RT Boost
| Preoperative IGRT (3D-CRT or IMRT)
Cohort A*
Patients receiving neoadjuvant or adjuvant
chemotherapy or both = 50 Gy in 25 daily fractions
OR
Patients receiving concurrent or interdigitated
chemotherapy = 44 Gy in 22 daily fractions
Cohort B
Patients not receiving chemotherapy =
50 Gy in 25 daily fractions
All patients: Surgery, 4-8 weeks after completion of preoperative RT (and chemo if given)
Postoperative Radiotherapy Boost: For patients with positive margins
*Chemotherapy is allowed for patients with deep, large (> 8 cm in maximum dimension), intermediate-to-high grade (histology grade 3 or 4, AJCC) sarcomas at the discretion of the treating medical oncologist who evaluates the patient for the planned chemotherapy
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| Study Size: | 102 |
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