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Dose Reduction of Postoperative Radiation for Treatment of Soft Tissue Sarcoma of the Arms and Legs
Trial Status: active
This phase II trial studies how well reduced-dose radiation therapy after surgery (postoperative) works in treating patients with soft tissue sarcoma of the arms and legs. Radiation therapy uses high energy rays to kill tumor cells and shrink tumors. Lowering the dose of postoperative radiation therapy and targeting a smaller area of tissue for treatment may be as effective as the standard dose and volume of radiation therapy to control soft tissue sarcoma after surgery and cause fewer and less severe long-term side effects.
Inclusion Criteria
Patients must be diagnosed with a primary soft tissue sarcoma of the extremity, confirmed by Memorial Sloan Kettering Cancer Center (MSKCC) pathologic review
Patients must have undergone margin-negative oncologic resection of their primary tumor, as confirmed by MSKCC pathologic review
Patients must be able to start radiation within 3 months from time of surgery
* If patient is receiving adjuvant chemotherapy, patient must start RT no longer than 3 months past their chemotherapy (chemo) treatment
Female patients of childbearing potential must have a negative serum pregnancy test within 14 days of radiation start (or if urine test, within 24 hours of radiation start)
Sexually active patients of childbearing potential must agree to use effective contraception
The use of chemotherapy will not be dictated by this trial. Patients are allowed to receive chemotherapy at the discretion of the disease management team (as is standard practice to make individualized decisions for each patient regarding the use of chemotherapy)
Exclusion Criteria
Patients with positive margins after surgical resection as indicated by MSKCC pathologic review
Patients with diagnosis of superficial myxofibrosarcoma with indistinct/infiltrative borders on preoperative magnetic resonance imaging (MRI)
Patients with multifocal disease in the extremity
Patients who have received prior radiotherapy at or adjacent to the primary tumor bed
Patients with a different invasive cancer requiring active treatment at the time of enrollment
Patients with any concurrent medical or psychiatric condition or disease which, in the investigator’s judgment, would make them inappropriate candidates for entry into this study
Additional locations may be listed on ClinicalTrials.gov for NCT04288375.
I. To evaluate local control at 2 years after a reduction in dose and volume for postoperative radiation therapy (RT) for extremity soft tissue sarcoma.
SECONDARY OBJECTIVES:
I. To evaluate late morbidity by 2 years (with late morbidity defined as limb functioning and grade >= 2 of the following toxicities: edema, subcutaneous fibrosis, fracture, or joint stiffness).
II. To evaluate the rate of major wound complications at 4 months post surgical resection (with wound complications defined as the need for a second operation, deep wound packing, prolonged dressing changes, or readmission for wound healing).
III. To evaluate acute toxicity (those toxicities that occur < 3 months of the completion of treatment) as measured via standard of care status checks during radiation.
IV. To estimate overall survival at 2 years.
OUTLINE:
Patients undergo IMRT once daily (QD) for 25 days in a row, except weekends and holidays. Treatment continues in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed up every 3-4 months for 2 years.
Trial PhasePhase II
Trial Typetreatment
Lead OrganizationMemorial Sloan Kettering Cancer Center
