Proton Beam Therapy in the Treatment of Esophageal Cancer

NCT ID: NCT03482791

Last Updated: 2025-04-06

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 22 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-04-19
• Study Completion Date: 2026-08-09

Brief Summary

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.

Conditions

Esophagus Cancer; Esophageal Cancer; Cancer of the Esophagus

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Arm 1: Resectable (proton beam therapy)

• 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

Group Type: EXPERIMENTAL

Proton beam therapy

Intervention Type: RADIATION

• The daily prescription dose will be 1.8 or 2 Gy RBE ("Relative Biologic Equivalence") to be delivered to the periphery of the planning target volume (PTV).
• The Mevion S-250 Proton Radiation Beam Therapy System will be used.

Patient-Reported Outcome Measures

Intervention Type: OTHER

-Prior to start of therapy, end of chemoradiation (day of end of treatment or up to 1 week after), 8 weeks, 4, 6, 9, and 12-months following end of chemoradiation

Arm 2: Unresectable (proton beam therapy)

• 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 Type: EXPERIMENTAL

Proton beam therapy

Intervention Type: RADIATION

• The daily prescription dose will be 1.8 or 2 Gy RBE ("Relative Biologic Equivalence") to be delivered to the periphery of the planning target volume (PTV).
• The Mevion S-250 Proton Radiation Beam Therapy System will be used.

Patient-Reported Outcome Measures

Intervention Type: OTHER

-Prior to start of therapy, end of chemoradiation (day of end of treatment or up to 1 week after), 8 weeks, 4, 6, 9, and 12-months following end of chemoradiation

Interventions

Proton beam therapy

• The daily prescription dose will be 1.8 or 2 Gy RBE ("Relative Biologic Equivalence") to be delivered to the periphery of the planning target volume (PTV).
• The Mevion S-250 Proton Radiation Beam Therapy System will be used.

Intervention Type: RADIATION

Patient-Reported Outcome Measures

-Prior to start of therapy, end of chemoradiation (day of end of treatment or up to 1 week after), 8 weeks, 4, 6, 9, and 12-months following end of chemoradiation

Intervention Type: OTHER

Other Intervention Names

PBT; PROs

Eligibility Criteria

Inclusion Criteria

• Histologically or cytologically documented adenocarcinoma or squamous cell carcinoma of the cervical or thoracic esophagus or gastroesophageal junction or cardia of stomach.
• 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
• Prior endoscopic mucosal resection (EMR) with a diagnosis of stage II or III esophageal cancer (AJCC 7th edition) is eligible, irrespective of margin status.
• Induction chemotherapy prior to concurrent chemoradiation is allowed.
• Prior thoracic radiation is allowable if degree of overlap with the esophageal radiotherapy treatment is deemed to be safe by the treating radiation oncologist.
• At least 18 years of age.
• ECOG performance status < 2
• Normal bone marrow and organ function as defined below:

• WBC > 2,500/mcL
• Platelets > 75,000/mcl
• Total bilirubin < 1.5 x institutional upper limit of normal (IULN)
• AST(SGOT)/ALT(SGPT) < 3.0 x IULN
• Creatinine < 1.5 x IULN OR Creatinine clearance > 50 mL/min/1.73 m2 for patients with creatinine levels above institutional normal
• Women of childbearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control, abstinence) prior to study entry and for the duration of study participation. Should a woman become pregnant or suspect she is pregnant while participating in this study, she must inform her treating physician immediately.
• Ability to understand and willingness to sign an IRB approved written informed consent document.
• English speaker.
• Financial coverage for proton therapy.

Exclusion Criteria

• Planned treatment with radiation therapy alone without concurrent chemotherapy or chemotherapy alone.
• Previous or concomitant cancers within the past 3 years other than curatively treated carcinoma in situ of the cervix, basal cell carcinoma of the skin, curative treatment for transitional cell carcinoma of the bladder, and low risk prostate cancer. Except for prostate cancer (which can be observed if low risk), other cancers listed must have been treated in the past 3 years without evidence of recurrence at the time of registration.
• 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
• Pregnant and/or breastfeeding. Patient must have a negative pregnancy test within 7 days of the start of treatment.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Washington University School of Medicine

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Gregory Vlacich, M.D., Ph.D.

Role: PRINCIPAL_INVESTIGATOR

Washington University School of Medicine

Locations

Washington University School of Medicine

St Louis, Missouri, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Related Links

http://www.siteman.wustl.edu

Alvin J. Siteman Cancer Center at Barnes-Jewish Hospital and Washington University School of Medicine

Other Identifiers

201803092

Identifier Type: -

Identifier Source: org_study_id