Prospective Phase I Trial of Hypofractionated Radiation Therapy in Retroperitoneal Sarcoma
Brigham and Women's Hospital
Summary
To determine the safety of moderately hypofractionated radiation in the treatment of primary and locally recurrent RPS, based on the evaluation of acute radiation-related toxicity profile of each participant (30-day radiation toxicity)
Description
To determine the safety of moderately hypofractionated radiation in the treatment of primary and locally recurrent RPS, based on the evaluation of acute radiation-related toxicity profile of each participant (30-day radiation toxicity)
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: * Participants must have a histologically confirmed STS of the retroperitoneal space or infra-peritoneal spaces of pelvis * Participant must have radiologically measurable disease (RECIST 1.1), as confirmed by abdomino-pelvic CT or MRI * Participant must have primary, locally recurrent, or metastatic disease requiring treatment of the retroperitoneal mass * Tumor must be suitable for radiotherapy and surgery based on pre-treatment CT scan/MRI in multidisciplinary discussion with surgeon and radiation oncologist (anticipated macroscopically complete resection, R0/R1 resecti…
Interventions
- RadiationRadiation Therapy
In this study, patients will receive a hypofractionated course of radiation therapy of 2.85 Gy x 15 fractions (42.75 Gy). If there are 2 or more patients with dose-limiting toxicities, the radiation course will be de-escalated to 2.7 Gy x 15 fractions (40.5 Gy).
- RadiationHypofractionationed Radiation Therapy
This group is receiving hypofractionated radiation therapy (shorter course of RT)
Location
- Brigham and Women's Hospital / Dana Farber Cancer InstituteBoston, Massachusetts