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

STATUS

Recruiting
participants needed

60
sponsor

Memorial Sloan Kettering Cancer Center

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Updated on 19 February 2024

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serum pregnancy test

sarcoma

primary tumor

soft tissue sarcoma

sarcoma of the extremity

Summary

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.

Details

Condition	Connective and Soft Tissue Neoplasm, Solid Tumors, Sarcoma, Sarcoma, Solid Tumors
Age	18-100 years
Treatment	Intensity-modulated radiation therapy (IMRT)
Clinical Study Identifier	NCT04288375
Sponsor	Memorial Sloan Kettering Cancer Center
Last Modified on	19 February 2024

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Eligibility		Yes	No	Not Sure
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
	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) or <70% myxoid component given the distinct failure pattern in these patients14
	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

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