RecruitingPhase 2NCT04506008

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


Sponsor

Vanderbilt-Ingram Cancer Center

Enrollment

40 participants

Start Date

Mar 2, 2021

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 18 Years

Inclusion Criteria3

  • 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 Criteria3

  • 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

Interventions

RADIATIONUltra-Hypo-fractionation Radiotherapy

Five fractions of pre-operative radiation

PROCEDUREResection

Surgery

OTHERQuestionnaire Administration

Ancillary studies

RADIATIONModerately-Hypo-fractionation Radiotherapy

15 fractions of pre-operative radiation


Locations(1)

Vanderbilt-Ingram Cancer Center

Nashville, Tennessee, United States

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

Visit

NCT04506008


Related Trials