Actively Recruiting
Proton-Spatially Fractionated Radiotherapy and Standard Radiation Therapy for the Treatment of Newly Diagnosed Retroperitoneal Soft Tissue Sarcoma
Led by Northwestern University · Updated on 2025-10-20
28
Participants Needed
1
Research Sites
221 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
This phase I/II trial studies the side effects and best dose of proton-spatially fractionated radiotherapy (P-SFRT) and to see how well it works with standard radiation therapy in treating patients with newly diagnosed retroperitoneal soft tissue sarcoma. Radiation therapy uses high energy x-rays, particles, or radioactive seeds to kill cancer cells and shrink tumors. Standard spatially fractionated radiotherapy (SFRT) refers to how the radiation is delivered to the tumor. SFRT means that different parts of the tumor are receiving different doses of radiation (fractionation) through beams that allow areas of higher and lower (peaks and valleys) of doses of the radiation. This spatial fractionation allows an overall high-dose radiation to be given in the peaks and those areas of the tumor may release cells and substances that may help with killing tumor cells, reducing tumor symptoms and shrinking tumors. Proton therapy is a type of radiation therapy that can overcome some of the barriers of standard SFRT. Protons are tiny radioactive particles that can be controlled in a beam to travel up to the tumor and, compared to the particles used in standard radiotherapy, proton therapy can deliver higher doses to the tumor because smaller doses of radiation are delivered to tissues away from the tumor. This allows radiation therapy dose-escalated (continuously increasing the dose of radiation) treatment to tumors even though the tumor is near radiation sensitive organs like the colon. Giving P-SFRT with standard radiation therapy may work better in treating patients with newly diagnosed retroperitoneal soft tissue sarcoma.
CONDITIONS
Official 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, untreated retroperitoneal soft tissue sarcoma confirmed by biopsy
- Tumor size at least 3 cm in diameter
- Measurable disease by RECIST version 1.1 criteria
- Age 18 years or older at consent
- Performance status 0 or 1 on ECOG scale or >70% on Karnofsky scale
- Leukocytes (white blood cells) ≥ 3,000/mcL without growth factor or transfusion before measurement
- Absolute neutrophil count ≥ 1,500/mcL
- Hemoglobin ≥ 9 g/dL
- Platelets ≥ 100,000/mcL
- Total bilirubin less than 1.5 times upper limit of normal (ULN) or direct bilirubin below ULN
- AST (SGOT) ≤ 2.5 times institutional ULN
- ALT (SGPT) ≤ 2.5 times institutional ULN
- Creatinine ≤ 1.5 times ULN
- Creatinine clearance ≥ 50 mL/min
- INR or PT/PTT < 1.5 times ULN unless receiving anticoagulant therapy with therapeutic levels
- Activated partial thromboplastin time (aPTT) < 1.5 times ULN unless receiving anticoagulant therapy with therapeutic levels
- Patients with prior or concurrent malignancy that does not interfere with study
- Patients of child-bearing potential must agree to use contraception during study
- Negative pregnancy test within 72 hours before CT simulation for P-SFRT for those of child-bearing potential
- Patients with sperm-producing reproductive capacity must use contraception during and 120 days after therapy and avoid sperm donation
- Ability to understand and sign informed consent
- Medically fit for surgery
- Plans for neoadjuvant radiation therapy and surgery with curative intent
You will not qualify if you...
- Soft tissue sarcoma subtypes where neoadjuvant chemotherapy is standard of care: extra-skeletal Ewing sarcoma, embryonal rhabdomyosarcoma, alveolar rhabdomyosarcoma, desmoplastic small round cell tumor
- Prior radiation therapy to the affected area
- Chemotherapy, radiotherapy, or antineoplastic agents within 28 days (6 weeks for nitrosureas or mitomycin C) before treatment
- Residual toxicities greater than grade 1 from prior anti-cancer therapy except alopecia
- Steroid or immunosuppressive therapy within 7 days before first dose
- Active tuberculosis
- Active hepatitis B or C infection
- Current or history of distant metastatic disease including brain (except isolated regional oligo-metastasis with curative intent)
- History of pneumonitis requiring steroids or current pneumonitis
- Live vaccine within 30 days before study therapy (seasonal injectable flu vaccine allowed)
- History of allogenic tissue or solid organ transplant
- Inflammatory bowel disease or rheumatologic disorders contraindicating retroperitoneal radiation
- Uncontrolled illness including uncontrolled hypertension, active infection, symptomatic heart failure, unstable angina, arrhythmia, recent major surgery within 30 days, or other conditions interfering with safety or compliance
- Psychiatric or social situations limiting compliance
- Pregnancy or nursing
- Expecting to become pregnant or impregnate a partner during study and for 120 days after
- Participation in another investigational study or device use within 4 weeks before first dose
- Other study-specific or disease-related exclusions such as inability to swallow oral medications if applicable
AI-Screening
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Trial Site Locations
Total: 1 location
1
Northwestern University
Chicago, Illinois, United States, 60611
Actively Recruiting
Research Team
S
Study Coordinator
CONTACT
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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