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Hypofractionated Proton Beam Therapy for Retroperitoneal Sarcoma (PROTONS-RPS Trial)

Phase 2

Waitlist Available

Led By Amol Narang, MD

Research Sponsored by Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

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 every 6 months, up to 2 years

Awards & highlights

PROTONS-RPS Trial Summary

This trial is evaluating the safety and efficacy of using H-PBT in the NA setting for patients with non-metastatic RPS.

Eligible Conditions

Retroperitoneal Sarcoma

PROTONS-RPS Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ every 6 months, up to 2 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~every 6 months, up to 2 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and every 6 months, up to 2 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

Overall serious adverse event rate for patients with primary resectable RPS receiving NA short-course h-PBT followed by surgical resection

Secondary outcome measures

Local recurrence-free survival (LRFS)

Rate of acute post-operative surgical complications in patients receiving NA short-course hypofractionated PBT

Rate of local or distant tumor progression from diagnosis to time of surgery after treatment with PBT

+2 more

PROTONS-RPS Trial Design

1Treatment groups

Experimental Treatment

Group I: Hypofractionated Proton Beam TherapyExperimental Treatment1 Intervention

5 fractions of 5 Gy of PBT to clinical tumor volume +/- an additional simultaneous 1 Gy per fraction to any pre-determined at-risk margin (for a total of 6 Gy per fraction x 5 fractions for at-risk margins as a simultaneous integrated boost (SIB)).

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Find a Location

Who is running the clinical trial?

Sidney Kimmel Comprehensive Cancer Center at Johns HopkinsLead Sponsor

558 Previous Clinical Trials

32,920 Total Patients Enrolled

Robert L. Sloan Fund for Cancer ResearchUNKNOWN

2 Previous Clinical Trials

43 Total Patients Enrolled

Amol Narang, MDPrincipal InvestigatorJohns Hopkins University

3 Previous Clinical Trials

79 Total Patients Enrolled

Frequently Asked Questions

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

Are there long-term risks associated with Hypofractionated Proton Beam Therapy?

"While there is some data backing the safety of Hypofractionated Proton Beam Therapy, it only received a score of 2 because there is no clinical evidence yet demonstrating its efficacy."

Answered by AI

Are people still being enrolled in this experiment?

"According to the information available on clinicaltrials.gov, this particular trial is not looking for any more patients at the moment. The trial was first posted on December 1st 2022 and was last updated on July 15th 2022. There are 460 other trials though that are actively recruiting patients right now."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Neoadjuvant Short-course Hypofractionated PBT for Non-metastatic RPS

2022. "Neoadjuvant Short-course Hypofractionated PBT for Non-metastatic RPS". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05302570.