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Proton Beam Therapy

Proton Therapy for Sarcoma (PRONTO Trial)

N/A
Recruiting
Led By Curtland Deville, 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 through study conclusion (estimated 5 years from opening)
Awards & highlights
No Placebo-Only Group

Summary

This trial studies proton therapy as a possible safe and effective treatment for certain sarcomas, with patients evaluated on wound healing and quality of life.

Who is the study for?
This trial is for adults (18+) with primary or locally recurrent sarcoma in the limbs or trunk. Participants should be able to perform daily activities with minimal assistance (WHO/ECOG status ≤2).
What is being tested?
The study tests if a short course of proton therapy, given in five sessions before surgery, is safe and effective for soft tissue sarcomas of the extremity and trunk. It will assess wound healing and life quality post-treatment.
What are the potential side effects?
Potential side effects may include skin reactions at the treatment site, fatigue, muscle stiffness, and changes in skin sensation. Long-term effects are monitored through questionnaires.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~median two year follow up
This trial's timeline: 3 weeks for screening, Varies for treatment, and median two year follow up for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Rate of major wound complications
Secondary study objectives
Functional Assessment of Cancer Therapy-General (FACT-G) scores
Incidence of acute grade ≥3 adverse events
Musculoskeletal Tumor Rating Scale scores
+5 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: Pre-operative hypofractionated proton therapyExperimental Treatment1 Intervention
Patients will have 5 fractions of proton therapy prior to surgical resection of their sarcoma.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
hypofractionation
2013
Completed Phase 2
~350

Find a Location

Who is running the clinical trial?

Robert L. Sloan Fund for Cancer ResearchUNKNOWN
4 Previous Clinical Trials
27 Total Patients Enrolled
Sidney Kimmel Comprehensive Cancer Center at Johns HopkinsLead Sponsor
570 Previous Clinical Trials
33,190 Total Patients Enrolled
Curtland Deville, MDPrincipal InvestigatorJohns Hopkins School of Medicine

Media Library

Hypofractionated Proton Therapy (Proton Beam Therapy) Clinical Trial Eligibility Overview. Trial Name: NCT05917301 — N/A
Soft Tissue Sarcoma Research Study Groups: Pre-operative hypofractionated proton therapy
Soft Tissue Sarcoma Clinical Trial 2023: Hypofractionated Proton Therapy Highlights & Side Effects. Trial Name: NCT05917301 — N/A
Hypofractionated Proton Therapy (Proton Beam Therapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05917301 — N/A
~27 spots leftby Dec 2030
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