Short Course Radiation Treatment for Patients With Primary or Locally Recurrent Retroperitoneal Sarcoma Prior to Surgery

Last updated: October 11, 2025
Sponsor: Brigham and Women's Hospital
Overall Status: Active - Recruiting

Phase

1

Condition

Sarcoma

Treatment

Hypofractionationed Radiation Therapy

Radiation Therapy

Clinical Study ID

NCT06812052
24-450
  • Ages > 18
  • All Genders

Study 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)

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Participants must have a histologically confirmed STS of the retroperitoneal spaceor infra-peritoneal spaces of pelvis

  • Participant must have radiologically measurable disease (RECIST 1.1), as confirmedby abdomino-pelvic CT or MRI

  • Participant must have primary, locally recurrent, or metastatic disease requiringtreatment of the retroperitoneal mass

  • Tumor must be suitable for radiotherapy and surgery based on pre-treatment CTscan/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 chronicinflammatory 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 perL, platelet count ≥80 × 10⁹ cells per L, and total bilirubin <2 times upper limit ofnormal)

  • Women of child-bearing potential must have a negative pregnancy test within 3 weeksprior to the first day of study treatment

  • Patients capable of childbearing/reproductive potential should use adequatecontraception

  • Ability to understand and the willingness to sign a written informed consentdocument

Exclusion

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 cellsarcoma, osteosarcoma, chondrosarcoma, aggressive fibromatosis, or sarcomatoid ormetastatic 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 thetreating 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 forteratogenic or abortifacient effects.

  • HIV-positive individuals on combination antiretroviral therapy are ineligiblebecause of the potential for increased sensitivity to RT

Study Design

Total Participants: 6
Treatment Group(s): 2
Primary Treatment: Hypofractionationed Radiation Therapy
Phase: 1
Study Start date:
May 29, 2025
Estimated Completion Date:
November 30, 2026

Study 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)

Connect with a study center

  • Brigham and Women's Hospital / Dana Farber Cancer Institute

    Boston, Massachusetts 02446
    United States

    Site Not Available

  • Brigham and Women's Hospital / Dana Farber Cancer Institute

    Boston 4930956, Massachusetts 6254926 02446
    United States

    Active - Recruiting

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