A Phase II Trial of Preoperative Proton Therapy in Soft-tissue Sarcomas of the Extremities and Body Wall

NACompletedINTERVENTIONAL
Enrollment

7

Participants

Timeline

Start Date

February 27, 2013

Primary Completion Date

May 19, 2022

Study Completion Date

May 19, 2022

Conditions
Soft Tissue Sarcoma
Interventions
RADIATION

proton radiation

proton radiation: 2 GyE/Day to isocenter, one treatment per day, 5 days per week for 25 treatments (=50 GyE to isocenter/25 fractions)

PROCEDURE

surgery (wide local excision; limb preservation surgery)

In areas with ample soft tissue that can be removed without compromising future function or wound closure, wide margins is the goal of treatment; associated rates of local failure are low in such instances. Margins will be determined by the surgeon; the goal is to achieve at least a 2 mm negative margin resection. However, smaller margins can be acceptable if it allows for limb-sparing surgery with conserved functional outcomes. Every effort will be made to have limb preservation surgery unless there is documented evidence of tumor progression during or after the course of radiation that would require amputation for an appropriate margin resection.

Trial Locations (1)

92354

Loma Linda University Medical Center / James M. Slater Proton Treatment Center, Loma Linda

All Listed Sponsors
lead

Loma Linda University

OTHER

NCT01819831 - A Phase II Trial of Preoperative Proton Therapy in Soft-tissue Sarcomas of the Extremities and Body Wall | Biotech Hunter | Biotech Hunter