About this trial
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 criteria
This trial does not accept healthy volunteersQualifiers
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 resection)
Disqualifiers
Sarcoma originating from bone structure, abdominal or gynecological viscera
Any of the following histological subtypes: gastrointestinal stromal tumor, rhabdomyosarcoma, primitive neuroectodermal tumor or other small round blue cell sarcoma, osteosarcoma, chondrosarcoma, aggressive fibromatosis, or sarcomatoid or metastatic carcinoma
Prior RT to the RPS
Prior abdominal or pelvic irradiation for other prior malignancy or other disease
Trial design
Single group
Treatments tested in this trial
Radiation Therapy
RadiationIn 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).
Hypofractionationed Radiation Therapy
RadiationThis group is receiving hypofractionated radiation therapy (shorter course of RT)
Treatment groups
Trial outcomes
Primary outcomes
Side effects from radiation therapy
Evaluation of acute radiation-related toxicity profile of each participant, specifically nausea, vomiting, diarrhea, and other gastrointestinal (GI) side effects.
Sponsors and contacts
Click on the lead sponsor to view all of their trials.