Proton Beam Therapy for Esophageal Cancer

Recruiting in Palo Alto (17 mi)

Overseen by Shahed Badiyan, M.D.

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Waitlist Available

Sponsor: Washington University School of Medicine

No Placebo Group

Approved in 4 Jurisdictions

Trial Summary

What is the purpose of this trial?

The investigators plan to include both operable and inoperable patients with esophagus cancer in this prospective trial. Since both proton and photon treatments are biologically equivalent, the investigators do not expect a difference in tumor control compared to intensity modulated radiation therapy (IMRT). The investigators have a prospective experience of physician-reported toxicity and patient outcome using IMRT for patients with inoperable esophagus cancer that will serve as a comparison group. For the resectable patients receiving trimodality therapy (chemoradiation followed by surgery), the investigators will carefully track toxicity and patient outcomes prospectively. The central hypothesis is that the biologic efficacy for tumor control should be similar between protons and photons, and therefore survival measures should be similar between the two groups, but that the main difference lies in the total severe toxicities experienced by the patients undergoing therapy.

Eligibility Criteria

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.

Inclusion Criteria

AST(SGOT)/ALT(SGPT) < 3.0 x IULN

Platelets > 75,000/mcl

Total bilirubin < 1.5 x institutional upper limit of normal (IULN)

Exclusion Criteria

Pregnant and/or breastfeeding. Patient must have a negative pregnancy test within 7 days of the start of treatment.

I am scheduled for radiation without chemo or chemo alone.

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

Participant Groups

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.

Group I: Arm 2: Unresectable (proton beam therapy) Experimental Treatment 2 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 Treatment 2 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

Proton Beam Therapy is already approved in United States, European Union, Japan, Canada for the following indications:

🇺🇸 Approved in United States as Proton Beam Therapy for:

• Various cancers including prostate, breast, lung, liver, and head and neck cancers

🇪🇺 Approved in European Union as Proton Therapy for:

• Various cancers including ocular melanoma, chordomas, chondrosarcomas, and certain pediatric cancers

🇯🇵 Approved in Japan as Proton Beam Therapy for:

• Various cancers including prostate, liver, and ocular melanoma

🇨🇦 Approved in Canada as Proton Therapy for:

• Various cancers including ocular melanoma and certain pediatric cancers

Find a Clinic Near You

Research Locations Nearby Select from list below to view details:

Washington University School of Medicine Saint Louis, MO

Who Is Running the Clinical Trial?

Washington University School of Medicine Lead Sponsor

References