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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 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 3 years

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

Computed Tomography

2017

Completed Phase 2

~2720

Resection

2023

Completed Phase 2

~420

Biopsy

2014

Completed Phase 4

~1090

Intensity-Modulated Radiation Therapy

2010

Completed Phase 3

~2160

Biospecimen Collection

2004

Completed Phase 2

~1700

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

Northwestern UniversityLead Sponsor

1,589 Previous Clinical Trials

917,059 Total Patients Enrolled

National Cancer Institute (NCI)NIH

13,672 Previous Clinical Trials

40,926,413 Total Patients Enrolled

3 Trials studying Retroperitoneal Sarcoma

218 Patients Enrolled for Retroperitoneal Sarcoma

Seth M Pollack, MDPrincipal InvestigatorNorthwestern University

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there any available positions for patients in this ongoing clinical trial?

"Information from clinicaltrials.gov indicates that this specific trial is currently not accepting new participants. Although it was initially listed on March 29, 2024, with the last update made on March 18, 2024. Despite its closure for enrollment, there are a total of 449 alternative studies actively recruiting patients at present."

Answered by AI

What are the main goals being pursued in this research endeavor?

"The primary aim of this investigation, to be evaluated within the initial 30-day treatment period, is achieving a Pathological complete response (Phase II). Secondary endpoints encompass Overall survival (OS) (Phase II), denoting the interval from baseline (day of surgery) till death attributed to any cause among assessable individuals; Incidence of adverse events (Phase I), delineated by frequency and severity according to CTCAE v5.0 criteria, with ≥ grade 3 toxicities analyzed distinctly alongside overall rates; Progression-free survival (PFS) (Phase II), gauged via disease progression manifesting as progressive disease per REC"

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Proton-Spatially Fractionated Radiotherapy and Standard Radiation Therapy for the Treatment of Newly Diagnosed Retroperitoneal Soft Tissue Sarcoma

2024. "Proton-Spatially Fractionated Radiotherapy and Standard Radiation Therapy for the Treatment of Newly Diagnosed Retroperitoneal Soft Tissue Sarcoma". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06327477.

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