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Proton Beam Therapy
Proton Beam Therapy for Esophageal Cancer
N/A
Waitlist Available
Led By Gregory Vlacich, M.D., Ph.D.
Research Sponsored by Washington University School of Medicine
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Creatinine < 1.5 x IULN OR Creatinine clearance > 50 mL/min/1.73 m2 for patients with creatinine levels above institutional normal
Staged by PET/CT and esophagogastroduodenoscopy (EGD) or endoscopic ultrasound (EUS) OR CT w/contrast and EGD to have stage II or III disease per AJCC 7th edition guidelines
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 12 months following chemoradiation (estimated to be 15 months)
Awards & highlights
Study Summary
This trial will compare proton and photon therapy for esophagus cancer to see if there is a difference in tumor control and patient outcome.
Who is the study for?
This trial is for adults with stage II or III esophageal cancer who can consent in English and have financial coverage for proton therapy. They must not be pregnant, agree to use contraception, and have normal organ function. Excluded are those with recent heart attacks, uncontrolled illnesses, or other cancers within the past 3 years.Check my eligibility
What is being tested?
The study compares the effectiveness of Proton Beam Therapy against Intensity Modulated Radiation Therapy (IMRT) in treating esophageal cancer. It aims to see if there's a difference in severe toxicities between these treatments while tracking tumor control and patient survival.See study design
What are the potential side effects?
While specific side effects aren't listed here, radiation therapies like Proton Beam Therapy may cause skin changes, fatigue, difficulty swallowing, nausea, weight loss due to eating difficulties and potential damage to nearby organs.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My kidney function is within the required range.
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My cancer is stage II or III, confirmed by specific scans and procedures.
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My blood tests for bone marrow and organ function are normal.
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My insurance or funds cover proton therapy.
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My cancer is in the esophagus, gastroesophageal junction, or stomach and has been confirmed by a lab test.
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I can do most of my daily activities without help.
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I had a procedure to remove cancer from my esophagus and it was stage II or III.
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I am 18 years old or older.
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I have had chemotherapy before starting treatment that combines chemotherapy and radiation.
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I had chest radiation before, but my doctor thinks it's safe to do more.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 12 months following chemoradiation (estimated to be 15 months)
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~12 months following chemoradiation (estimated to be 15 months)
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Change from baseline to 6 months following end of chemoradiation in patient-reported outcomes of PBT for esophageal cancer as measured by the MDASI-Plus
Change in baseline to 12 months following end of chemoradiation in patient-reported outcomes of PBT for esophageal cancer as measured by the MDASI-Plus
Patient-reported outcomes of PBT for esophageal cancer as measured by the 4-Item CES-D
+5 moreSecondary outcome measures
Overall survival (OS)of PBT for patients with resectable versus unresectable esophageal
Overall survival (OS)of PBT for patients with resectable versus unresectable esophageal cancer
Progression-free survival (PFS) of proton beam therapy (PBT) for patients with resectable
+1 moreTrial Design
2Treatment groups
Experimental Treatment
Group I: Arm 2: Unresectable (proton beam therapy)Experimental Treatment2 Interventions
Proton beam therapy: total dose of 59.4 or 60 Gy
Standard of care chemotherapy - the clinical trial doesn't dictate anything about the chemotherapy given, it is the treating physician's decision
Patient-reported outcome measures (PROs) performed at several time points
Group II: Arm 1: Resectable (proton beam therapy)Experimental Treatment2 Interventions
Proton beam therapy: total dose of 50 or 50.4 Gy
Standard of care chemotherapy - the clinical trial doesn't dictate anything about the chemotherapy given, it is the treating physician's decision
Surgery should ideally be performed no later than 8 to 10 weeks after completing chemoradiation
Patient-reported outcome measures (PROs) performed at several time points
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Proton beam therapy
2013
N/A
~200
Find a Location
Who is running the clinical trial?
Washington University School of MedicineLead Sponsor
1,931 Previous Clinical Trials
2,299,687 Total Patients Enrolled
Gregory Vlacich, M.D., Ph.D.Principal InvestigatorWashington University School of Medicine
1 Previous Clinical Trials
20 Total Patients Enrolled
Shahed Badiyan, M.D.Principal InvestigatorWashington University School of Medicine
2 Previous Clinical Trials
95 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- My kidney function is within the required range.My cancer is stage II or III, confirmed by specific scans and procedures.My blood tests for bone marrow and organ function are normal.My insurance or funds cover proton therapy.My cancer is in the esophagus, gastroesophageal junction, or stomach and has been confirmed by a lab test.I can do most of my daily activities without help.I am scheduled for radiation without chemo or chemo alone.I do not have any severe illnesses that could interfere with the study.I had a procedure to remove cancer from my esophagus and it was stage II or III.I am 18 years old or older.I have had chemotherapy before starting treatment that combines chemotherapy and radiation.I had chest radiation before, but my doctor thinks it's safe to do more.I haven't had any cancer except for certain low-risk types in the last 3 years, or if I did, it was treated without coming back.
Research Study Groups:
This trial has the following groups:- Group 1: Arm 2: Unresectable (proton beam therapy)
- Group 2: Arm 1: Resectable (proton beam 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.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are there any remaining spots available for enrollment in this experiment?
"According to the clinicaltrials.gov database, this medical trial is not currently seeking participants. This particular study was first listed on April 19th 2018 and its last edit occurred on October 10th 2022; regardless, there are 377 other studies that have open spots for enrolment as of now."
Answered by AI
What risks do Patient-Reported Outcome Measures pose to individuals?
"There is some evidence confirming the safety of Patient-Reported Outcome Measures, therefore it was awarded a score of 2. This Phase 2 trial has yet to generate data validating its efficacy."
Answered by AI
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