Recruiting
Phase 1

Short Course Radiation

Sponsor:

Brigham and Women's Hospital

Code:

NCT06812052

Conditions

Retroperitoneal Sarcoma

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Radiation Therapy

Hypofractionationed Radiation Therapy

Study Details

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

Study ID

NCT06812052

Start date

May 29, 2025

Status verified date

May, 2025

Completion date

Nov, 2026

Anticipated

Primary completion date

Nov, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

6 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Hypofractionated Radiation Therapy

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

Interventions

Radiation Therapy

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

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

Primary outcome measure

  • Side effects from radiation therapy [ Time Frame: From enrollment to 30-days after the completion of radiation treatment ]

Central Contacts and Locations

Central contacts

Miranda Lam

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

Locations

Brigham and Women's Hospital / Dana Farber Cancer Institute

Recruiting

Boston, Massachusetts, United States, 02446

Contacts

Miranda Lam

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

More Information

Sponsor

Brigham and Women's Hospital

Last update posted

Oct 14, 2025

Last verified

May, 2025

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Brigham and Women's Hospital on 2025-10-14.