NCT04506008

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

Prospective Observational Trial of Two Neoadjuvant Hypofractionated Radiotherapy Regimens Followed by Surgical Resection in the Treatment of Soft Tissue Sarcomas

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 40 (estimated)
• Sponsor: Vanderbilt-Ingram Cancer Center · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Soft Tissue Sarcomas

Interventions

Type	Name	Description
RADIATION	Ultra-Hypo-fractionation Radiotherapy	Five fractions of pre-operative radiation
PROCEDURE	Resection	Surgery
OTHER	Questionnaire Administration	Ancillary studies
RADIATION	Moderately-Hypo-fractionation Radiotherapy	15 fractions of pre-operative radiation

Timeline

• Start date: 2021-03-02
• Primary completion: 2026-06-01
• Completion: 2027-06-01
• First posted: 2020-08-10
• Last updated: 2025-03-28

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study