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

Memorial Sloan Kettering Cancer Center (MSK)

Status and phase: Enrolling; Phase 2

Conditions: Soft Tissue Sarcoma

Treatments: Radiation: Intensity-modulated radiation therapy (IMRT)

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT04288375

20-064

Details and patient eligibility

About

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.

Enrollment: 60 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 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).

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 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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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60 participants in 1 patient group

extremity soft tissue sarcoma (STS)

Experimental group

Description:

Postoperative radiation therapy to the primary site with a reduction in radiation dose and volume. Specifically, the tumor bed plus a margin of 2cm craniocaudally and 1.5cm radially will be utilized to create the clinical target volume. The total dose will consist of 50 Gy in 25 fractions.

Treatment:

Radiation: Intensity-modulated radiation therapy (IMRT)