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

Phase 2

Recruiting

• Conditions: Soft Tissue Sarcomas
• Interventions: Radiation: Ultra-Hypo-fractionation Radiotherapy; Procedure: Resection; Radiation: Moderately-Hypo-fractionation Radiotherapy; Other: Questionnaire Administration

• Registration Number: NCT04506008
• Lead Sponsor: Vanderbilt-Ingram Cancer Center

Brief Summary

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.

Detailed 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.

Study Timeline

• Study First Submitted: 2020-08-05
• Study First Submitted QC: 2020-08-05
• Study First Posted: 2020-08-10
• Study Start: 2021-03-02
• Status Verified: 2025-03
• Last Update Submitted: 2025-03-24
• Last Update Posted: 2025-03-28
• Primary Completion: 2026-06
• Study Completion: 2027-06

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 40

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Group I (UH HRT)	Resection	Patients undergo HRT daily for a total of 5 fractions followed by surgery.
Group I (UH HRT)	Ultra-Hypo-fractionation Radiotherapy	Patients undergo HRT daily for a total of 5 fractions followed by surgery.
Group II (MH HRT)	Resection	Patients undergo HRT daily for a total of 15 fractions followed by surgery.
Group II (MH HRT)	Moderately-Hypo-fractionation Radiotherapy	Patients undergo HRT daily for a total of 15 fractions followed by surgery.
Group I (UH HRT)	Questionnaire Administration	Patients undergo HRT daily for a total of 5 fractions followed by surgery.
Group II (MH HRT)	Questionnaire Administration	Patients undergo HRT daily for a total of 15 fractions followed by surgery.

Primary Outcome Measures

Name	Time	Method
Local control rate	Approximately 2 years	Will be estimated with a Beta-Binomial model with Beta(0.5, 0.5) as the prior distribution. The median and a 95% credible interval of the posterior distribution will be reported.

Secondary Outcome Measures

Name	Time	Method
Complication rate	Approximately 2 years	The complication rate will be modeled with a Beta-Binomial model with Beta(0.5, 0.5) as the prior distribution, and it will be monitored continuously throughout the study. The complication rate will also be modeled with a Beta-Binomial model with Beta(0.5, 0.5) as the prior distribution, and it will be monitored continuously throughout the study.

Trial Locations

Locations (1)

Vanderbilt-Ingram Cancer Center; 🇺🇸 Nashville, Tennessee, United States