← Back to Search

Proton Beam Therapy

Treatment (P-SFRT, IG-IMRT) for Retroperitoneal Sarcoma

Phase 1 & 2
Recruiting
Led By Seth M Pollack, MD
Research Sponsored by Northwestern University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 3 years
Awards & highlights

Study Summary

"This trial is testing a new type of radiation therapy called proton-spatially fractionated radiotherapy (P-SFRT) in combination with standard radiation therapy to treat patients with a specific type of cancer

Who is the study for?
This trial is for individuals with newly diagnosed retroperitoneal soft tissue sarcoma. Participants should be suitable for radiation therapy and surgery to remove the tumor. Specific eligibility criteria are not provided, but typically include factors like overall health status, age range, and having no other medical conditions that could interfere with the treatment or skew results.Check my eligibility
What is being tested?
The study is testing a combination of proton-spatially fractionated radiotherapy (P-SFRT) alongside standard radiation therapy. P-SFRT aims to deliver high doses of radiation directly to the tumor while sparing surrounding healthy tissues. The goal is to determine the best dose and assess how well this approach works compared to traditional methods.See study design
What are the potential side effects?
Potential side effects may include skin reactions at the site of radiation, fatigue, nausea, changes in appetite, and possible damage to nearby organs due to radiation exposure. Proton therapy seeks to minimize these by targeting the tumor more precisely.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 3 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 3 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Pathological complete response (Phase II)
Recommended phase II dose (Phase I)
Secondary outcome measures
Incidence of adverse events (Phase I)
Overall response rate (ORR) (Phase II)
Overall survival (OS) ( (Phase II)
+1 more

Trial Design

1Treatment groups
Experimental Treatment
Group I: Treatment (P-SFRT, IG-IMRT)Experimental Treatment6 Interventions
Patients undergo P-SFRT over 1 fraction and then undergo IG-IMRT over 25-28 fractions for 35 to 42 days. Patients undergo surgical resection 21 to 35 days after radiation therapy. Patients undergo blood sample collection during screening and on study. Patients also undergo biopsy during screening and CT on study and on follow up.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Biospecimen Collection
2004
Completed Phase 2
~1720
Computed Tomography
2017
Completed Phase 2
~2720
Biopsy
2014
Completed Phase 4
~1090
Resection
2023
Completed Phase 2
~420
Intensity-Modulated Radiation Therapy
2010
Completed Phase 3
~2160

Find a Location

Who is running the clinical trial?

Northwestern UniversityLead Sponsor
1,601 Previous Clinical Trials
915,631 Total Patients Enrolled
National Cancer Institute (NCI)NIH
13,718 Previous Clinical Trials
40,963,363 Total Patients Enrolled
3 Trials studying Retroperitoneal Sarcoma
218 Patients Enrolled for Retroperitoneal Sarcoma
Seth M Pollack, MDPrincipal InvestigatorNorthwestern University
~19 spots leftby Jul 2027
Unbiased ResultsWe believe in providing patients with all the options.
Your Data Stays Your DataWe only share your information with the clinical trials you're trying to access.
Verified Trials OnlyAll of our trials are run by licensed doctors, researchers, and healthcare companies.
Back to top