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
SWOG Cancer Research Network
Summary
This clinical trial compares the effect of short-course ultrahypofractionated radiation therapy over 5 days (UHRT-5) to standard-course radiation therapy over 25 days (RT-25) in treating patients with soft tissue sarcomas of the extremities that may be primary or that may have come back to nearby tissue or lymph nodes after a period of improvement (locally recurrent) and that can be removed by surgery (resectable). Radiation therapy uses high energy x-rays, particles, or radioactive seeds to kill tumor cells and shrink tumors. 3-dimensional (3D) conformal radiation therapy (CRT) uses a computer to create a 3D picture of the tumor. This allows doctors to give the highest possible dose of radiation to the tumor, while sparing the normal tissue as much as possible. Intensity-modulated radiation therapy (IMRT) is a type of 3D radiation therapy that uses computer-generated images to show the size and shape of the tumor. Thin beams of radiation of different intensities are aimed at the tumor from many angles. This type of radiation therapy reduces the damage to healthy tissue near the tumor. Standard-course (fractionated) radiation divides the total dose of radiation therapy into several smaller, equal doses delivered over a period of several days. Ultrahypofractionated radiation therapy delivers higher doses of radiation therapy over a shorter period of time and may kill more tumor cells and have fewer side effects. Giving UHRT-5 may be as effective as RT-25 in treating patients with primary or locally recurrent soft tissue sarcomas of the extremities that are resectable. It may also improve quality of life by requiring fewer treatments.
Description
PRIMARY OBJECTIVE: I. To evaluate whether the incidence of local tumor recurrence at 2-years after randomization with short-course radiation is non-inferior to standard-course radiation among participants with high-risk, resectable soft tissue sarcoma. SECONDARY OBJECTIVES: I. To estimate and compare between arms the incidence of acute wound complications. II. To estimate and compare between arms the incidence of late-term complications associated with radiation at 2-years post-surgery. III. To estimate and compare between arms changes in physician-assessed functional outcome from pre-ran…
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: * Participants must have histological evidence of a soft tissue sarcoma from core or incisional biopsy. Participants must have a primary or locally recurrent tumor. Stage II-IIIB (by American Joint Committee on Cancer \[AJCC\] 8th edition) soft tissue sarcoma is required * Prior partial excision or partial excisional biopsy of the tumor, with imaging evidence of gross residual disease \> 1cm in longest dimension (stage II-IIIB) * Participants must have a primary site of disease in the extremity, including the shoulder girdle and hip girdle but excluding the hands and fe…
Interventions
- Radiation3-Dimensional Conformal Radiation Therapy
Undergo RT-25 with 3D-CRT
- Radiation3-Dimensional Conformal Radiation Therapy
Undergo UHRT-5 with 3D CRT
- ProcedureBiospecimen Collection
Undergo blood sample collection
- ProcedureComputed Tomography
Undergo CT
- RadiationIntensity-Modulated Radiation Therapy
Undergo RT-25 with IMRT
- RadiationIntensity-Modulated Radiation Therapy
Undergo UHRT-5 with IMRT
- ProcedureMagnetic Resonance Imaging
Undergo MRI
- ProcedureSurgical Procedure
Undergo surgical resection
Locations (67)
- University of Alabama at Birmingham Cancer CenterBirmingham, Alabama
- Kaiser Permanente-AnaheimAnaheim, California
- Kaiser Permanente-Deer Valley Medical CenterAntioch, California
- Kaiser Permanente-BellflowerBellflower, California
- Kaiser Permanente DublinDublin, California
- Kaiser Permanente-FremontFremont, California