Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.
3.1 Inclusion Criteria
3.1.1 Males and females age ≥ 18 years.
3.1.2 Newly diagnosed, histological confirmation of soft tissue sarcoma of the extremities (including limb girdle) or superficial trunk that present as either –
- Deemed a candidate for complete macroscopic resection of the primary sarcoma.
OR
- Having had non-oncologic excisional procedure with positive or uncertain resection margins and still be eligible if the evaluating sarcoma surgeon recommends oncologic re-resection of the surgical bed to obtain negative margins after a course of preoperative radiation therapy.
3.1.3 No evidence of nodal or distant metastases as determined by clinical examination on any form of imaging.
3.1.4 Eastern Cooperative oncology Group (ECOG) Performance Status (PS) ≤ 3 (Appendix I).
3.1.5 Life expectancy greater than 6 months.
3.1.6 Negative pregnancy test done ≤ 7 days prior to registration, for women of childbearing potential only. Patients capable of childbearing must use adequate contraception.
3.1.7 Ability to complete questionnaire(s) by themselves or with assistance.
3.1.8 Ability to provide written informed consent.
3.1.9 Willing to return to enrolling institution for follow-up (during the Active Monitoring Phase of the study).
3.2 Exclusion Criteria
3.2.1 Previous radiation therapy to the site of the sarcoma or area surrounding it such that it would be encompassed by the radiation field needed to treat the current sarcoma. In other words, treatment on this trial would require re-irradiation of tissues.
3.2.2 Patients with nodal or distant metastases.
3.2.3 Rhabdomyosarcoma, soft tissue osteosarcoma, soft tissue Ewing sarcoma, and benign histologies.
3.2.4 Any of the following:
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- Pregnant women
- Nursing women
- Men or women of childbearing potential who are unwilling to employ adequate contraception