NCT06812052 · Brigham and Women's Hospital
Short Course Radiation Treatment for Patients With Primary or Locally Recurrent Retroperitoneal Sarcoma Prior to Surgery
What this study is about
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)
View original scientific 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)
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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
Where
- Boston, Massachusetts
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Oct 14, 2025 · Source of record for eligibility and locations