Prospective Phase I Trial of Hypofractionated Radiation Therapy in Retroperitoneal Sarcoma

Status: Recruiting
Location: See location...
Intervention Type: Radiation
Study Type: Interventional
Study Phase: Phase 1
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
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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

Locations
United States
Massachusetts
Brigham and Women's Hospital / Dana Farber Cancer Institute
RECRUITING
Boston
Contact Information
Primary
Miranda Lam
miranda_lam@dfci.harvard.edu
617-732-7948
Time Frame
Start Date: 2025-05-29
Estimated Completion Date: 2026-11
Participants
Target number of participants: 6
Treatments
Experimental: Hypofractionated Radiation Therapy
This group is receiving hypofractionated radiation therapy (shorter course of radiation therapy)
Related Therapeutic Areas
Sponsors
Leads: Brigham and Women's Hospital

This content was sourced from clinicaltrials.gov