Purpose of this Study
Participants will be randomly assigned to receive either standard radiation therapy given over 25 days or a shorter course of radiation therapy given over 5 days before surgery. Researchers will compare the two approaches to learn if the shorter treatment works as well as the standard treatment for this type of cancer.
Who Can Participate?
Eligibility
Participants may be able to join if they are adults with a newly diagnosed or locally recurring soft tissue sarcoma that has not spread to other parts of the body. They must be candidates for surgery to remove the tumor while preserving the affected limb. Participants cannot have had a prior surgery or biopsy that completely or partially removed the tumor, and they cannot have a fungating tumor.
Contact Julia Hurrelbrink
julia.hurrelbrink@duke.edu
(919) 681-7460
Age Range
18-110
Sex/Genders
Male (cisgender)
Female (cisgender)
Non-binary or gender fluid
Transgender male
Transgender female
Looking for Healthy Participants
No
What is Involved?
Description
This study is comparing the usual longer course of radiation therapy with a shorter course of radiation therapy given before surgery. Researchers want to learn if the shorter treatment can provide similar cancer control, reduce the risk of the cancer returning, and improve quality of life by requiring fewer radiation treatments.
Locations
Duke University Hospital
Visit Timing
Weekdays
Compensation
No
Spanish Materials Available
Yes
Study Details
Full Title
S2505, Phase III Randomized Study Testing Non-Inferiority of Short-Course Ultra-Hypofractionated Radiation (UHRT-5) Versus Standard Fractionation (RT-25) for Stage II-IIIB Extremity, Resectable Soft Tissue Sarcoma
Principal Investigator
Nicole
Larrier
Protocol Number
PRO00121366
NCT ID
NCT07615049
Phase
III
Enrollment Status
Pending Open to Enrollment