Hypofractionated Pre-Operative Radiation Therapy for Localized, Resectable Soft Tissue Sarcoma of the Extremity or Superficial Trunk

Overview

About this study

We propose conducting a single arm, prospective study to evaluate the efficacy and safety of a preoperative hypofractionated course, 42.75 Gy in 15 fractions, for localized, extremity and superficial trunk soft tissue sarcomas. The biologic equivalent dose of this regimen is 45.20 Gy10, similar to 43.83 Gy10 associated with conventionally fractionated 50 Gy in 25 fractions, to determine acute wound complications rates, analyze local failure rate, disease-free survival, overall survival, patterns of relapse, late toxicities, quality of life/patient-reported outcomes, and cost differences. We hypothesize a 15 fraction hypofractionated radiation therapy course will be associated with equivalent short term toxicity rates and oncologic outcomes, as compared to historical standards.

Participation eligibility

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.

Inclusion Criteria:

  • Males and females, age ≥ 18 years.
  • 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.
  • No evidence of nodal or distant metastases as determined by clinical examination on any form of imaging.
  • Eastern Cooperative oncology Group (ECOG) Performance Status (PS) ≤ 3.
  • Life expectancy greater than 6 months.
  • Negative pregnancy test done ≤ 7 days prior to registration, for women of childbearing potential only. Patients capable of childbearing must use adequate contraception.
  • Ability to complete questionnaire(s) by themselves or with assistance.
  • Ability to provide written informed consent.
  • Willing to return to enrolling institution for follow-up (during the Active Monitoring Phase of the study).

Exclusion Criteria:

  • 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.
  • Patients with nodal or distant metastases.
  • Rhabdomyosarcoma, soft tissue osteosarcoma, soft tissue Ewing sarcoma, and benign histologies.
  • Any of the following:
      •  
    • Pregnant women;
    • Nursing women;
    • Men or women of childbearing potential who are unwilling to employ adequate contraception.

Participating Mayo Clinic locations

Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.

Mayo Clinic Location Status Contact

Rochester, Minn.

Mayo Clinic principal investigator

Safia Ahmed, M.D.

Open for enrollment

Contact information:

Cancer Center Clinical Trials Referral Office

(855) 776-0015

More information

Publications

Publications are currently not available
.
CLS-20507456

Mayo Clinic Footer