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

NCT06812052 | Recruiting Phase 1 FDA Device

• 1 other identifier: 24-450
• Study Type: interventional
• Target: 6
• Locations: 1 country
• Sites: 1

Brief 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)

Conditions

Retroperitoneal Sarcoma

Outcome Measures

Primary Outcomes (1)

• Side effects from radiation therapy

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

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

Study Arms (1)

Hypofractionated Radiation Therapy

EXPERIMENTAL

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

Radiation: Radiation Therapy; Radiation: Hypofractionationed Radiation Therapy

Interventions

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).

Hypofractionated Radiation Therapy

Hypofractionationed Radiation Therapy RADIATION

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

Hypofractionated Radiation Therapy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Brigham and Women's Hospital: lead

Study Sites (1)

Brigham and Women's Hospital / Dana Farber Cancer Institute

Boston, Massachusetts, 02446, United States

RECRUITING

MeSH Terms

Interventions

Radiotherapy

Intervention Hierarchy (Ancestors)

Therapeutics

Study Officials

• Miranda Lam

  Dana-Farber/Brigham and Women's Cancer Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Miranda Lam

CONTACT

617-732-7948; miranda_lam@dfci.harvard.edu

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Radiation Oncologist

Study Record Dates

• First Submitted: January 27, 2025
• First Posted: February 6, 2025
• Study Start: May 29, 2025
• Primary Completion (Estimated): November 1, 2026
• Study Completion (Estimated): November 1, 2026
• Last Updated: October 14, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: ICF

Locations

US (1)