Radiation Therapy Before Surgery for Localized, Resectable Soft Tissue Sarcoma of the Extremity and Superficial Trunk

Mayo Clinic

Status and phase: Active, not recruiting; Phase 2

Conditions: Stage II Soft Tissue Sarcoma of the Trunk and Extremities AJCC v8; Stage IA Soft Tissue Sarcoma of the Trunk and Extremities AJCC v8; Stage I Soft Tissue Sarcoma of the Trunk and Extremities AJCC v8; Resectable Soft Tissue Sarcoma; Stage IB Soft Tissue Sarcoma of the Trunk and Extremities AJCC v8

Treatments: Procedure: Resection; Radiation: Hypofractionated Radiation Therapy; Other: Questionnaire Administration; Other: Quality-of-Life Assessment

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT04562480

MC1973 (Other Identifier)

NCI-2020-06811 (Registry Identifier)

19-011871 (Other Identifier)

Details and patient eligibility

About

This phase II trial investigates the effects of hypofractionated radiation therapy before surgery on wound complications associated with surgery in treating patients with soft tissue sarcoma of the extremity (arms, hands, legs or feet) and superficial trunk that has not spread to other parts of the body (localized) and can be removed by surgery (resectable). Hypofractionated is a shorter radiation therapy treatment length (fewer radiation treatment days) and administers the total radiation dose as larger daily doses, compared to conventionally fractionated therapy.

Full description

PRIMARY OBJECTIVE:

I. To report the major acute wound complication rate associated with hypofractionated preoperative radiation therapy, 42.75 Gy in 15 fractions.

SECONDARY OBJECTIVES:

I. To report the 5-year local failure rate associated with hypofractionated preoperative radiation therapy, 42.75 Gy in 15 fractions.

II. To report the 5-year disease-free survival rate associated with hypofractionated preoperative radiation therapy, 42.75 Gy in 15 fractions.

III. To report the 5-year overall survival rate associated with hypofractionated preoperative radiation therapy, 42.75 Gy in 15 fractions.

IV. To report long-term toxicity rates associated with hypofractionated preoperative radiation therapy, 42.75 Gy in 15 fractions.

V. To describe patterns of relapse associated with hypofractionated preoperative radiation therapy, 42.75 Gy in 15 fractions.

VI. To describe patient reported outcomes/quality-of-life outcomes with hypofractionated preoperative radiation therapy, 42.75 Gy in 15 fractions.

OUTLINE:

Patients undergo hypofractionated radiation therapy once daily (QD) (except weekends and holidays) over 3 weeks for a total of 15 fractions. Within 3-6 weeks after completion of radiation therapy, patients undergo surgical resection.

After completion of study treatment, patients are followed up at 4-8 weeks, every 3-4 months for years 1-2, and every 6 months for years 3-5.

Enrollment: 120 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 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

• 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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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120 participants in 1 patient group

Treatment (hypofractionated radiation therapy, resection)

Experimental group

Description:

Patients undergo hypofractionated radiation therapy QD (except weekends and holidays) over 3 weeks for a total of 15 fractions. Within 3-6 weeks after completion of radiation therapy, patients undergo surgical resection.

Treatment:

Other: Quality-of-Life Assessment

Other: Questionnaire Administration

Radiation: Hypofractionated Radiation Therapy

Procedure: Resection