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Proton Beam Therapy

Proton + Standard Radiation Therapy for 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

No Placebo-Only Group

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.

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.

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Pathological complete response (Phase II)

Recommended phase II dose (Phase I)

Secondary study objectives

Incidence of adverse events (Phase I)

Overall response rate (ORR) (Phase II)

Overall survival (OS) ( (Phase II)

+1 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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

Biopsy

2014

Completed Phase 4

~1090

Biospecimen Collection

2004

Completed Phase 3

~2020