Hypofractionated Radiotherapy Followed by Surgical Resection in the Treatment of Soft Tissue Sarcomas

Vanderbilt University Medical Center

Status and phase: Enrolling; Phase 2

Conditions: Soft Tissue Sarcomas

Treatments: Radiation: Moderately-Hypo-fractionation Radiotherapy; Other: Questionnaire Administration; Procedure: Resection; Radiation: Ultra-Hypo-fractionation Radiotherapy

Study type: Interventional

Funder types: Other

Identifiers

NCT04506008

VICC SAR 2062

Details and patient eligibility

About

The trial will use neoadjuvant hypofractionated radiotherapy followed by surgical resection in the treatment for soft tissue sarcoma. It will allow patients to be treated over a shorter course (5 or 15 days of radiation) compared to the traditional 5 week regimen. It is proposed that this will be possible without increasing the risk of wound complication or local recurrence compared with a traditional 5 week course of pre-operative radiation.

Full description

Study Objectives:

Primary:

• To investigate the efficacy of neoadjuvant hypo-fractionated radiotherapy (HRT) followed by surgical resection in the treatment of soft tissue sarcoma (STS) as measured by local control
• Examine the side effect profile using Radiation Therapy Oncology Group (RTOG) and Common Terminology Criteria for Adverse Events (CTCAE) acute and late side effects criteria and major and minor post-operative complication rates.

OUTLINE: Patients are assigned to 1 of 2 groups by the radiation oncologist.

GROUP I (ULTRA-HYPOFRACTIONATION [UH]): Patients undergo HRT daily for a total of 5 fractions followed by surgery.

GROUP II (MODERATE HYPOFRACTIONATION [MH]): Patients undergo HRT daily for a total of 15 fractions followed by surgery.

After completion of study treatment, patients are followed up within 3 months, then every 3-6 months for a minimum of 2 years.

Enrollment: 40 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Histologic diagnosis of a soft tissue sarcoma of extremity, pelvis, chest wall or trunk/abdominal wall (non-retroperitoneal location)
• ECOG performance status 0-2
• Patient must be deemed able to comply with radiation treatment and surgery

Exclusion criteria

• History of prior radiation to the same area to be irradiated
• Pregnancy
• Active collagen vascular disease or patients genetically predisposed to increased radiation related side effects

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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40 participants in 2 patient groups

Group I (UH HRT)

Experimental group

Description:

Patients undergo HRT daily for a total of 5 fractions followed by surgery.

Treatment:

Radiation: Ultra-Hypo-fractionation Radiotherapy

Procedure: Resection

Other: Questionnaire Administration

Group II (MH HRT)

Experimental group

Description:

Patients undergo HRT daily for a total of 15 fractions followed by surgery.

Treatment:

Procedure: Resection

Other: Questionnaire Administration

Radiation: Moderately-Hypo-fractionation Radiotherapy