Short Course Radiation Treatment for Patients with Primary or Locally Recurrent Retroperitoneal Sarcoma Prior to Surgery
Purpose
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)
Condition
- Retroperitoneal Sarcoma
Eligibility
- Eligible Ages
- Over 18 Years
- Eligible Genders
- All
- Accepts 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 resection) - Age: 18 years or older - ECOG performance status ≤2 - Absence of history of bowel obstruction, mesenteric ischemia, or severe chronic inflammatory bowel disease. - Normal renal function (calculated creatinine clearance ≥50 mL/min) - Normal bone marrow and hepatic function (white blood cell count ≥2·5 × 10⁹ cells per L, platelet count ≥80 × 10⁹ cells per L, and total bilirubin <2 times upper limit of normal) - Women of child-bearing potential must have a negative pregnancy test within 3 weeks prior to the first day of study treatment - Patients capable of childbearing/reproductive potential should use adequate contraception - Ability to understand and the willingness to sign a written informed consent document
Exclusion Criteria
- 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 - Prior different invasive malignancy may be eligible per the discretion of the treating investigator and review by the Principal Investigator (PI) - Prior chemotherapy or immunotherapy within 6 weeks of start of RT - Pregnant women are excluded from this study because RT has the potential for teratogenic or abortifacient effects. - HIV-positive individuals on combination antiretroviral therapy are ineligible because of the potential for increased sensitivity to RT
Study Design
- Phase
- Phase 1
- Study Type
- Interventional
- Allocation
- N/A
- Intervention Model
- Single Group Assignment
- Primary Purpose
- Treatment
- Masking
- None (Open Label)
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
|
Experimental Hypofractionated Radiation Therapy |
This group is receiving hypofractionated radiation therapy (shorter course of radiation therapy) |
|
Recruiting Locations
Brigham and Women's Hospital / Dana Farber Cancer Institute
Boston, Massachusetts 02446
Boston, Massachusetts 02446
More Details
- Status
- Recruiting
- Sponsor
- Brigham and Women's Hospital
Detailed 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)