Clinical trial Recruiting at 1 site Phase 2 Interventional Ages 18 and up

Shorter radiation treatment followed by surgery for soft tissue sarcomas

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

Run by Vanderbilt-Ingram Cancer Center · NCT04506008 · Data updated 2026-11-12

This study is testing if a shorter radiation treatment followed by surgery can help people with soft tissue sarcomas while causing fewer side effects.

More Soft Tissue Sarcomas trials

Quick facts

PhasePhase 2
Study typeInterventional
Ages18 Years and up
SexAll
Enrollment40 (estimated)
SponsorVanderbilt-Ingram Cancer Center
Academic / other
Drugs / interventionsradiation
Locations1 site (Nashville, Tennessee)
StatusRecruiting
StartedMarch 2, 2021
Main results expectedJune 2026
Study endsJune 2027
Registry record updatedMarch 28, 2025
Trial IDNCT04506008 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a good fit

Ideal candidates include individuals with a histologic diagnosis of soft tissue sarcoma located in the extremities, pelvis, chest wall, or trunk/abdominal wall, who have an ECOG performance status of 0-2.

Probably not a fit

Patients with a history of prior radiation to the treatment area, pregnancy, or active collagen vascular disease may not benefit from this study.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This trial investigates the use of neoadjuvant hypofractionated radiotherapy followed by surgical resection in patients with soft tissue sarcomas. Participants will receive either ultra-hypofractionated radiotherapy over 5 days or moderately hypofractionated radiotherapy over 15 days, aiming to reduce the overall treatment duration compared to traditional methods. The study will assess the efficacy of these approaches in achieving local control of the disease and evaluate the side effects and complication rates associated with the treatments. Patients will be monitored for a minimum of two years post-treatment to gather comprehensive data on outcomes.

Why it matters

Potential benefit: If successful, this approach could significantly reduce treatment time for patients with soft tissue sarcomas without compromising safety or effectiveness.

How similar studies have gone: Other studies have shown promise with hypofractionated radiotherapy approaches, suggesting potential for success in this novel application.

Who can join: the full rules

Show full inclusion / exclusion criteria
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

Where it's running

  • Vanderbilt-Ingram Cancer Center
    Nashville, Tennessee, United States
    Recruiting

Study contacts

  • Principal investigator: Eric Shinohara, MD — Vanderbilt Medical Center
  • Study coordinator: Vanderbilt-Ingram Service for Timely Access
  • Email: cip@vumc.org
  • Phone: 800-811-8480

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.