Phase II Trial of Neoadjuvant Hypofractionated Radiotherapy Versus Conventionally Fractionated Radiotherapy for Soft Tissue Sarcomas

Status: Recruiting
Location: See location...
Intervention Type: Radiation
Study Type: Interventional
Study Phase: Phase 2
SUMMARY

This research study is designed to find out if radiation therapy treatment prior to surgery is safe and effective to treat soft tissue sarcomas. 30 participants with soft tissue sarcoma will be enrolled and can expect to be on study for up to 5 years.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• Biopsy proven soft tissue sarcoma of the extremity, trunk, or head and neck

• No prior sarcoma-directed chemotherapy or radiotherapy

• Age ≥ 18 years

• Karnofsky performance status ≥ 60

• Able to understand and sign an informed consent

• Life expectancy of greater than 12 weeks

• Hypofractionated or conventionally fractionated radiotherapy using Intensity Modulated Radiation Therapy (IMRT) are both deemed feasible and safe neoadjuvant treatments, at the treating physician's discretion

• Operable disease and medically fit for surgery, based on the opinion of the consulting surgeon; surgery within 5-14 days of completion of radiation therapy (RT)

• Adequate bone marrow function as defined by absolute neutrophil count \> 500/mcL, hemoglobin \> 8 g/dL, platelets \> 50,000/mcL; adequate renal function as defined by creatinine clearance \> 30 mL/min

Locations
United States
Wisconsin
University of Wisconsin Hospital and Clinics
RECRUITING
Madison
Contact Information
Primary
Cancer Connect
clinicaltrials@cancer.wisc.edu
800-622-8922
Time Frame
Start Date: 2022-04-06
Estimated Completion Date: 2026-11
Participants
Target number of participants: 30
Treatments
Active_comparator: Conventional Fractionated
radiation treatments will be delivered daily, delivered over a maximum of 7 weeks from the first treatment, surgery will be within 5-14 days of completion of RT
Experimental: Hypofractionated
the maximum frequency of treatment will be every day and the minimum frequency will be every other day, delivered over a maximum of 3 weeks from the first treatment, surgery will be within 5-14 days of completion of RT
Related Therapeutic Areas
Sponsors
Leads: University of Wisconsin, Madison

This content was sourced from clinicaltrials.gov