Actively Recruiting
First-in-Human Phase I and II Study to Determine Safety and Efficacy of Proton-Spatially Fractionated Radiotherapy (P-SFRT) in Retroperitoneal Soft Tissue Sarcoma
Led by Northwestern University · Updated on 2025-10-20
28
Participants Needed
1
Research Sites
52 weeks
Total Duration
On this page
Sponsors
N
Northwestern University
Lead Sponsor
N
National Cancer Institute (NCI)
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are evaluating proton-spatially fractionated radiotherapy (P-SFRT) combined with standard radiation therapy for treating newly diagnosed retroperitoneal soft tissue sarcoma. This phase I/II trial aims to find the best dose of P-SFRT and assess its safety and effectiveness when used before surgery. Proton therapy may allow higher radiation doses to tumors near sensitive organs by delivering radiation more precisely. Participants receive one dose of P-SFRT, followed by image-guided intensity-modulated radiation therapy (IG-IMRT) over 25-28 sessions lasting 35 to 42 days. Surgery to remove the tumor occurs 21 to 35 days after radiation therapy finishes. Blood samples and biopsies are taken before treatment, with CT scans done during the study and follow-up. During the study, patients are monitored closely with lab tests, imaging, and assessments. Researchers measure the highest tolerated P-SFRT dose, tumor response, progression-free survival, and overall survival up to three years. Follow-up visits occur 30 and 90 days after surgery, then regularly for three years to track safety and outcomes.
CONDITIONS
Brief Title
Proton-Spatially Fractionated Radiotherapy and Standard Radiation Therapy for the Treatment of Newly Diagnosed Retroperitoneal Soft Tissue Sarcoma
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Newly diagnosed, histologically or cytologically confirmed, untreated retroperitoneal soft tissue sarcoma
- Tumor size at least 3 cm in diameter
- Measurable disease per RECIST version 1.1
- Age 18 years or older at consent
- ECOG performance status 0 or 1, or Karnofsky score above 70%
- Leukocytes (WBC) count of 3,000/mcL or higher
- Absolute neutrophil count (ANC) of 1,500/mcL or higher
- Hemoglobin level of 9 g/dL or higher
- Platelet count of 100,000/mcL or higher
- Total bilirubin less than 1.5 times upper normal limit
- AST (SGOT) no more than 2.5 times upper normal limit
- ALT (SGPT) no more than 2.5 times upper normal limit
- Creatinine no more than 1.5 times upper normal limit
- Creatinine clearance at least 50 mL/min
- INR, PT, or PTT less than 1.5 times upper normal limit (unless on anticoagulants within therapeutic range)
- Activated partial thromboplastin time (aPTT) less than 1.5 times upper normal limit (unless on anticoagulants within therapeutic range)
- Patients with prior or concurrent malignancies that do not interfere with study
- Agreement to use adequate contraception for patients of child-bearing potential and sperm-producing capacity
- Ability and willingness to sign informed consent
- Medically fit for surgery
- Planned neoadjuvant radiation therapy and surgery with curative intent
You will not qualify if you...
- Certain sarcoma subtypes where neoadjuvant chemotherapy is standard (e.g., extra-skeletal Ewing sarcoma, embryonal rhabdomyosarcoma)
- Prior radiation therapy to the affected area
- Chemotherapy, radiotherapy, or antineoplastic agents within 28 days before treatment start (6 weeks for some drugs)
- Unrecovered adverse events greater than grade 1 from prior anti-cancer therapy (except alopecia)
- Steroid or immunosuppressive therapy within 7 days before trial treatment
- Active tuberculosis or hepatitis B or C infection
- Current or history of distant metastatic disease (except some regional occurrences)
- History of pneumonitis requiring steroids or current pneumonitis
- Live vaccine within 30 days before study therapy
- Allogenic tissue or solid organ transplant
- History of inflammatory bowel or certain rheumatologic disorders contraindicating radiation
- Uncontrolled illnesses like hypertension, infection, heart failure, unstable angina, arrhythmia, recent major surgery
- Psychiatric or social issues limiting compliance
- Pregnant or nursing, or planning pregnancy during the study and 120 days after
- Participation in another investigational study within 4 weeks before treatment
- Other study-specific or disease-related exclusions
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person) including biopsy and blood sample collection
Duration - 35 to 42 days
Participants undergo proton-spatially fractionated radiotherapy (P-SFRT) in 1 fraction followed by image-guided intensity modulated radiation therapy (IG-IMRT) over 25 to 28 fractions.
Daily visits for 25 to 28 radiation therapy sessions
Duration - 1 day
Participants undergo surgical resection of the tumor 21 to 35 days after completing radiation therapy.
1 visit (in-person) for surgery
Duration - Up to 36 months
Participants are followed up after surgery to monitor recovery and treatment outcomes including CT scans and blood sample collection.
Visits at 30 and 90 days after surgery, then periodic visits up to 36 months
Trial Site Locations
Total: 1 location
1
Northwestern University
Chicago, Illinois, United States, 60611
Actively Recruiting
Research Team
S
Study Coordinator
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
1
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