Dose Reduction of Postoperative Radiation for Soft Tissue Sarcoma of the Arms and Legs

Running, not enrolling · Phase 2

Conditions studied: Soft Tissue Sarcoma

In brief

The investigators are doing this study to find out whether lowering the dose of postoperative radiation therapy and targeting a smaller area of tissue for treatment is as effective as the standard dose and volume of radiation therapy to control soft tissue sarcoma after surgery. They also want to find out whether the study approach causes fewer and less severe long-term side effects than the standard approach.

Key facts

Study ID

NCT04288375

Run by

Memorial Sloan Kettering Cancer Center

People needed

65

Starts

2020-02-26

Expected to finish

2027-02-01

Last updated by the study team

2026-02-20

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Patients must be diagnosed with a primary soft tissue sarcoma of the extremity, confirmed by MSKCC pathologic review
• Age at the time of enrollment of ≥18 years
• 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 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).

You may not qualify if…

• 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 MRI16 (see Appendix Figure 1 for reference figure)
• Patients with multifocal disease in the extremity
• Patients who have received prior radiotherapy at or adjacent to the primary tumor bed
• Patients with a differentinvasive 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

Where it is running

• Memorial Sloan Kettering Basking Ridge (All protocol activities) — Basking Ridge, New Jersey, United States
• Memorial Sloan Kettering Monmouth (All protocol activities) — Middletown, New Jersey, United States
• Memorial Sloan Kettering Bergen (All protocol activities) — Montvale, New Jersey, United States
• Memorial Sloan Kettering Commack (All protocol activities) — Commack, New York, United States
• Memorial Sloan Kettering Westchester (All protocol activities) — Harrison, New York, United States
• Memorial Sloan Kettering Cancer Center — New York, New York, United States
• Memorial Sloan Kettering Nassau (All protocol activities) — Uniondale, New York, United States

Full record on ClinicalTrials.gov

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