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NCT Number: NCT06812052

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

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)

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Brigham and Women's Hospital / Dana Farber Cancer Institute

Boston, Massachusetts, 02446, United States

Location status: Recruiting

Location contact

Miranda Lam

CONTACT

[email protected]

617-732-7948

About this study

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

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

radiation therapy

Radiation

In 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

Radiation

This group is receiving hypofractionated radiation therapy (shorter course of RT)

Primary outcomes

  1. Side effects from radiation therapy

    Time frame: From enrollment to 30-days after the completion of radiation treatment

    Evaluation of acute radiation-related toxicity profile of each participant, specifically nausea, vomiting, diarrhea, and other gastrointestinal (GI) side effects.

Study contacts

Contact information is provided by the study sponsor or research team.

Miranda Lam

CONTACT

[email protected]

617-732-7948

Sponsors and collaborators

Lead sponsor

Brigham and Women's Hospital

Other

Registry information

Official study title

Prospective Phase I Trial of Hypofractionated Radiation Therapy in Retroperitoneal Sarcoma

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Feb 6, 2025
Registry last updated
Oct 14, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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