Short course radiation treatment for retroperitoneal sarcoma before surgery

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This clinical trial aims to evaluate the safety of moderately hypofractionated radiation therapy in patients with primary or locally recurrent retroperitoneal sarcoma. Participants will undergo radiation treatment, and the study will assess the acute radiation-related toxicity experienced within 30 days. The goal is to determine if this approach can be safely integrated into the treatment plan prior to surgical intervention. The study will involve careful monitoring of participants' health and response to the treatment.

Why it matters

Who can join: the full rules

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 it's running

• Brigham and Women's Hospital / Dana Farber Cancer Institute
  Boston, Massachusetts, United States Recruiting

Study contacts

• Principal investigator: Miranda Lam — Dana-Farber/Brigham and Women's Cancer Center
• Study coordinator: Miranda Lam
• Email: miranda_lam@dfci.harvard.edu
• Phone: 617-732-7948

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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• Proton therapy combined with standard radiation for treating retroperitoneal sarcoma

  This study is testing a new type of radiation therapy combined with standard treatment to see if it helps people with newly diagnosed retroperitoneal sarcoma before they have surgery.

  Recruiting Phase 1/2 Northwestern University · Chicago, Illinois · NCT06327477

• Using Abemaciclib and Radiation Therapy Before Surgery for High-Risk Retroperitoneal Sarcoma

  This study is testing if taking a medication called abemaciclib along with radiation therapy before surgery can help shrink tumors in patients with high-risk retroperitoneal sarcoma.

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• Pre-surgery ultra-hypofractionated radiation for retroperitoneal soft tissue sarcoma

  This study tests a very short course of pre-surgery high-dose radiation followed by surgery to see if it is safe and manageable for people with retroperitoneal soft tissue sarcoma.

  Recruiting Cancer Institute and Hospital, Chinese Academy of Medical Sciences · Beijing, Beijing Municipality · NCT05224934

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.