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RECRUITING

NCT03801876

PHASE3

Comparing Proton Therapy to Photon Radiation Therapy for Esophageal Cancer

Sponsor: NRG Oncology

View on ClinicalTrials.gov

Summary

This trial studies how well proton beam radiation therapy compared with intensity modulated photon radiotherapy works in treating patients with stage I-IVA esophageal cancer. Proton beam radiation therapy uses a beam of protons (rather than x-rays) to send radiation inside the body to the tumor without damaging much of the healthy tissue around it. Intensity modulated photon radiotherapy uses high-energy x-rays to deliver radiation directly to the tumor without damaging much of the healthy tissue around it. It is not yet known whether proton beam therapy or intensity modulated photon radiotherapy will work better in treating patients with esophageal cancer.

Official title: Phase III Randomized Trial of Proton Beam Therapy (PBT) Versus Intensity Modulated Photon Radiotherapy (IMRT) for the Treatment of Esophageal Cancer

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

300

Start Date

2019-06-26

Completion Date

2031-12-21

Last Updated

2026-04-03

Healthy Volunteers

Conditions

Interventions

PROCEDURE

Biospecimen Collection

Undergo blood sample collection

DRUG

Capecitabine

Oral

DRUG

Carboplatin

Given IV

PROCEDURE

Computed Tomography

Undergo CT or PET/CT

DRUG

Docetaxel

PROCEDURE

Esophagectomy

Undergo esophagectomy

DRUG

Fluorouracil

RADIATION

Intensity-Modulated Radiation Therapy

Undergo IMRT

DRUG

Leucovorin Calcium

Oral

DRUG

Oxaliplatin

DRUG

Paclitaxel

Given IV

PROCEDURE

Positron Emission Tomography

Undergo PET/CT

RADIATION

Proton Beam Radiation Therapy

Undergo PBT

OTHER

Quality-of-Life Assessment

Ancillary studies

OTHER

Questionnaire Administration

Ancillary studies

Inclusion Criteria: * PRIOR TO STEP 1 REGISTRATION: * Histologically proven diagnosis of adenocarcinoma or squamous cell carcinoma of the thoracic esophagus or gastroesophageal junction (Siewert I-II) * Stage I-IVA, excluding T4b, according to the American Joint Committee on Cancer (AJCC) 8th edition based on the following diagnostic workup: * History/physical examination * Whole-body fludeoxyglucose F-18 (FDG)-positron emission tomography (PET)/computed tomography (CT) with or without contrast (preferred) or chest/abdominal (include pelvic if clinically indicated) CT with contrast * For patients who DID NOT receive induction chemotherapy, scan must occur within 30 days prior to Step 1 registration * For patients who DID receive induction chemotherapy, scan must occur: * Within 30 days after final induction chemotherapy dose; OR * Within 30 days prior to Step 1 registration * Note: Patients who had prior endoscopic mucosal resection (EMR) with a diagnosis of AJCC stage I-IVA, excluding T4b, esophageal cancer are eligible * Surgical consultation to determine whether or not the patient is a candidate for resection after completion of chemoradiation * Induction chemotherapy for the current malignancy prior to concurrent chemoradiation allowed if last dose is no more than 90 days and no less than 10 days prior to Step 1 registration; only FOLFOX, CAPOX, durvalumab-fluorouracil, leucovorin, oxaliplatin and docetaxel (FLOT) (D-FLOT) and FLOT will be allowed as the induction chemotherapy regimen * Age ≥ 18 * Zubrod performance status 0, 1, or 2 * Absolute neutrophil count (ANC) (within 30 days prior to Step 1 registration) * For patients who DID NOT receive induction chemotherapy: ANC ≥ 1,500 cells/mm\^3 * For patients who DID receive induction chemotherapy: ANC ≥ 1,000 cells/mm\^3 * Platelets (within 30 days prior to Step 1 registration) * For patients who DID NOT receive induction chemotherapy: Platelets ≥ 100,000/uL * For patients who DID receive induction chemotherapy: Platelets ≥ 75,000/uL * Hemoglobin ≥ 8.0 g/dl (Note: The use of transfusion or other intervention to achieve Hgb ≥ 8.0 g/dl is acceptable) (within 30 days prior to Step 1 registration) * Serum creatinine ≤ 1.5 X upper limit of normal (ULN) or creatinine clearance \> 40 mL/min estimated by Cockcroft-Gault formula (within 30 days prior to Step 1 registration) * Total bilirubin ≤ 1.5 x upper limit of normal (ULN) (within 30 days prior to Step 1 registration) * Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 3 x ULN (within 30 days prior to Step 1 registration) * Negative pregnancy test (serum or urine) within 14 days prior to Step 1 registration for women of child bearing potential * The patient or a legally authorized representative must provide study-specific informed consent prior to study entry Exclusion Criteria: * Cervical esophageal cancers arisen from 15-18 cm from the incisors * Patients with T4b disease according to the AJCC 8th edition * Definitive clinical or radiologic evidence of metastatic disease * Any active malignancy within 2 years of study registration that may alter the course of esophageal cancer treatment * Prior thoracic radiotherapy that would result in overlap of radiation therapy fields * Severe, active co-morbidity defined as follows: * Active uncontrolled infection requiring IV antibiotics at the time of Step 1 registration * Uncontrolled symptomatic congestive heart failure, unstable angina, or cardiac arrhythmia not controlled by any device or medication at the time of Step 1 registration * Myocardial infarction within 3 months prior to Step 1 registration * Pregnant and/or nursing females * Human immunodeficiency virus (HIV) positive with CD4 count \< 200 cells/microliter. Note that patients who are HIV positive are eligible, provided they are under treatment with highly active antiretroviral therapy (HAART) and have a CD4 count ≥ 200 cells/microliter within 30 days prior to registration. Note also that HIV testing is not required for eligibility for this protocol. This exclusion criterion is necessary because the treatments involved in this protocol may be significantly immunosuppressive * PRIOR TO STEP 2 REGISTRATION: * Unable to obtain confirmation of payment coverage (insurance or other) for either possible radiation treatment

Locations (95)

Mayo Clinic Hospital in Arizona

Phoenix, Arizona, United States

Mayo Clinic in Arizona

Scottsdale, Arizona, United States

University of Arkansas for Medical Sciences

Little Rock, Arkansas, United States

UM Sylvester Comprehensive Cancer Center at Coral Gables

Coral Gables, Florida, United States

UM Sylvester Comprehensive Cancer Center at Deerfield Beach

Deerfield Beach, Florida, United States

UM Sylvester Comprehensive Cancer Center at Doral

Doral, Florida, United States

University of Miami Miller School of Medicine-Sylvester Cancer Center

Miami, Florida, United States

Miami Cancer Institute

Miami, Florida, United States

UM Sylvester Comprehensive Cancer Center at Kendall

Miami, Florida, United States

Orlando Health Cancer Institute

Orlando, Florida, United States

UM Sylvester Comprehensive Cancer Center at Plantation

Plantation, Florida, United States

Emory Proton Therapy Center

Atlanta, Georgia, United States

Emory University Hospital Midtown

Atlanta, Georgia, United States

Emory University Hospital/Winship Cancer Institute

Atlanta, Georgia, United States

Emory Saint Joseph's Hospital

Atlanta, Georgia, United States

Alton Memorial Hospital

Alton, Illinois, United States

Northwestern Medicine Cancer Center Kishwaukee

DeKalb, Illinois, United States

Northwestern Medicine Cancer Center Delnor

Geneva, Illinois, United States

Memorial Hospital East

Shiloh, Illinois, United States

Northwestern Medicine Cancer Center Warrenville

Warrenville, Illinois, United States

Maryland Proton Treatment Center

Baltimore, Maryland, United States

University of Maryland/Greenebaum Cancer Center

Baltimore, Maryland, United States

UM Upper Chesapeake Medical Center

Bel Air, Maryland, United States

Massachusetts General Hospital Cancer Center

Boston, Massachusetts, United States

McLaren Cancer Institute-Bay City

Bay City, Michigan, United States

Corewell Health Dearborn Hospital

Dearborn, Michigan, United States

Wayne State University/Karmanos Cancer Institute

Detroit, Michigan, United States

Weisberg Cancer Treatment Center

Farmington Hills, Michigan, United States

McLaren Cancer Institute-Flint

Flint, Michigan, United States

Karmanos Cancer Institute at McLaren Greater Lansing

Lansing, Michigan, United States

McLaren Cancer Institute-Lapeer Region

Lapeer, Michigan, United States

McLaren Cancer Institute-Owosso

Owosso, Michigan, United States

Corewell Health William Beaumont University Hospital

Royal Oak, Michigan, United States

Corewell Health Beaumont Troy Hospital

Troy, Michigan, United States

Mayo Clinic Health System in Albert Lea

Albert Lea, Minnesota, United States

Mercy Hospital

Coon Rapids, Minnesota, United States

Unity Hospital

Fridley, Minnesota, United States

Mayo Clinic Health Systems-Mankato

Mankato, Minnesota, United States

Minnesota Oncology Hematology PA-Maplewood

Maplewood, Minnesota, United States

Hennepin County Medical Center

Minneapolis, Minnesota, United States

Mayo Clinic Radiation Therapy-Northfield

Northfield, Minnesota, United States

Mayo Clinic in Rochester

Rochester, Minnesota, United States

Ridgeview Medical Center

Waconia, Minnesota, United States

Siteman Cancer Center at Saint Peters Hospital

City of Saint Peters, Missouri, United States

Siteman Cancer Center at West County Hospital

Creve Coeur, Missouri, United States

Mercy Hospital Springfield

Springfield, Missouri, United States

Washington University School of Medicine