A Phase II Trial of Preoperative Proton Therapy in Soft-tissue Sarcomas of the Extremities and Body Wall
Data support preoperative radiotherapy as one of the standard options in the management of
large or high-grade extremity soft tissue sarcomas (STS). The advantages of preoperative
radiotherapy are lower doses and smaller radiation volumes; these may be used to effect
improvement of long-term side effects and extremity function. Another potential advantage is
assisting surgery through tumor shrinkage and reduction of tumor cell seeding. The
disadvantage of preoperative radiation is the higher likelihood of postoperative wound
complications, but in a prospective phase III trial these complications were found to be
generally temporary and without significant effect on long term function.
Combined conservative surgery and radiotherapy has shown to achieve excellent local control
in sarcoma patients following margin-negative surgery, but late radiation morbidity and
reduced quality of life may result from adjuvant radiation. The dosimetric advantage of
proton radiotherapy may translate into reduced acute and late effects due to improved
normal-tissue sparing in the treatment of extremity and truncal STS. However, these
potential advantages need to be validated in clinical trials. The investigators propose a
phase II study to evaluate the effect of preoperative proton radiotherapy on the reduction
of late radiation morbidity, patterns of failure, and impact of late radiation morbidity on
general quality of life (QOL).
Interventional
Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Late radiation toxicities (>grade 2 lymphedema, subcutaneous fibrosis, and joint stiffness)
at 2 years from the start of radiation treatment
No
Gary Yang, MD
Principal Investigator
Loma Linda University Medical Center
United States: Institutional Review Board
5120263
NCT01819831
March 2013
March 2016
Name | Location |
---|---|
Loma Linda University Medical Center / James M. Slater Proton Treatment Center | Loma Linda, California 92354 |