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Proton Beam Therapy

Proton Beam Therapy for Esophageal Cancer

N/A

Waitlist Available

Led By Shahed Badiyan, M.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

Histologically or cytologically documented adenocarcinoma or squamous cell carcinoma of the cervical or thoracic esophagus or gastroesophageal junction or cardia of stomach

Must not have

Planned treatment with radiation therapy alone without concurrent chemotherapy or chemotherapy alone

Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia not controlled by pacer device, myocardial infarction within 3 months of registration, or psychiatric illness/social situations that would limit compliance with study requirements

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 12 months following chemoradiation (estimated to be 15 months)

Awards & highlights

No Placebo-Only Group

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.

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.

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 below

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My kidney function is within the required range.

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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.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I am scheduled for radiation without chemo or chemo alone.

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I do not have any severe illnesses that could interfere with the study.

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)

This trial's timeline: 3 weeks for screening, Varies for treatment, and 12 months following chemoradiation (estimated to be 15 months) for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

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 more

Secondary study objectives

Progression-free survival (PFS) of proton beam therapy (PBT) for patients with resectable

Progression-free survival (PFS) of proton beam therapy (PBT) for patients with resectable versus unresectable esophageal cancer

Awards & Highlights

No Placebo-Only Group

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

Trial 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

0 / 7Eligibility criteria met