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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 weeks3 visits
Treatment ~ Varies
Follow Up ~ median two year follow up
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~median two year follow up
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 moreAwards & 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
571 Previous Clinical Trials
33,314 Total Patients Enrolled
Curtland Deville, MDPrincipal InvestigatorJohns Hopkins School of Medicine
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I can take care of myself but might not be able to do heavy physical work.My cancer started in the back of my abdomen.I am scheduled for treatments like chemotherapy, targeted therapy, or immunotherapy.I am 18 years old or older.I have had radiation therapy before.I do not have another cancer that could shorten my life, except for certain skin cancers or localized breast or cervical cancers that were completely removed.My cancer is in the limbs or torso and hasn't spread far.
Research Study Groups:
This trial has the following groups:- Group 1: Pre-operative hypofractionated proton therapy
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.