Recruiting
Phase 2

Hypofractionated Radiotherapy

Sponsor:

Vanderbilt-Ingram Cancer Center

Code:

NCT04506008

Conditions

Soft Tissue Sarcomas

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Ultra-Hypo-fractionation Radiotherapy

Resection

Questionnaire Administration

Moderately-Hypo-fractionation Radiotherapy

Study Details

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.

Conditions

Soft Tissue Sarcomas

Study ID

NCT04506008

Start date

Mar 2, 2021

Status verified date

Mar, 2025

Completion date

Jun, 2027

Anticipated

Primary completion date

Jun, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

Enrollment

40 participants

Anticipated

Allocation

Non randomized

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Group I (UH HRT)

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

experimental: Group II (MH HRT)

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

Interventions

Ultra-Hypo-fractionation Radiotherapy

Five fractions of pre-operative radiation

Resection

Surgery

Questionnaire Administration

Ancillary studies

Moderately-Hypo-fractionation Radiotherapy

15 fractions of pre-operative radiation

Primary outcome measure

  • Local control rate [ Time Frame: Approximately 2 years ]

Central Contacts and Locations

Central contacts

Vanderbilt-Ingram Service for Timely Access

800-811-8480cip@vumc.org

Locations

Vanderbilt-Ingram Cancer Center

Recruiting

Nashville, Tennessee, United States, 37232

Contacts

Vanderbilt-Ingram Service for Timely Access

800-811-8480cip@vumc.org

Principal Investigator:

Eric Shinohara, MD

More Information

Sponsor

Vanderbilt-Ingram Cancer Center

Last update posted

Mar 28, 2025

Last verified

Mar, 2025

Keywords

  • Hypofractionated Radiotherapy

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Vanderbilt-Ingram Cancer Center on 2025-03-28.