Prospective Observational Trial of Two Neoadjuvant Hypofractionated Radiotherapy Regimens Followed by Surgical Resection in the Treatment of Soft Tissue Sarcomas
Who is this study for? Adult patients with Soft Tissue Sarcoma
What treatments are being studied? Hypofractionated Radiotherapy
Status: Recruiting
Location: See location...
Intervention Type: Radiation, Other, Procedure
Study Type: Interventional
Study Phase: Phase 2
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
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:
• 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
Locations
United States
Tennessee
Vanderbilt-Ingram Cancer Center
RECRUITING
Nashville
Contact Information
Primary
Vanderbilt-Ingram Service for Timely Access
cip@vumc.org
800-811-8480
Time Frame
Start Date: 2021-03-02
Estimated Completion Date: 2027-06
Participants
Target number of participants: 40
Treatments
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.
Related Therapeutic Areas
Sponsors
Leads: Vanderbilt-Ingram Cancer Center