Comparing Proton Therapy to Photon Radiation Therapy for Esophageal Cancer

Recruiting now · Phase 3

Conditions studied: Clinical Stage I Esophageal Adenocarcinoma AJCC v8, Clinical Stage I Esophageal Squamous Cell Carcinoma AJCC v8, Clinical Stage I Gastroesophageal Junction Adenocarcinoma AJCC v8, Clinical Stage II Esophageal Adenocarcinoma AJCC v8, Clinical Stage II Esophageal Squamous Cell Carcinoma AJCC v8, Clinical Stage II Gastroesophageal Junction Adenocarcinoma AJCC v8, Clinical Stage III Esophageal Adenocarcinoma AJCC v8, Clinical Stage III Esophageal Squamous Cell Carcinoma AJCC v8, Clinical Stage III Gastroesophageal Junction Adenocarcinoma AJCC v8, Clinical Stage IVA Esophageal Adenocarcinoma AJCC v8, Clinical Stage IVA Esophageal Squamous Cell Carcinoma AJCC v8, Clinical Stage IVA Gastroesophageal Junction Adenocarcinoma AJCC v8, Thoracic Esophagus Squamous Cell Carcinoma

In brief

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.

Key facts

Study ID

NCT03801876

Run by

NRG Oncology

People needed

300

Starts

2019-06-26

Expected to finish

2031-12-21

Last updated by the study team

2026-06-25

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Karmanos Cancer Institute at McLaren Greater Lansing — Lansing, Michigan, United States (enrolling)
• Corewell Health William Beaumont University Hospital — Royal Oak, Michigan, United States (enrolling)
• Wayne State University/Karmanos Cancer Institute — Detroit, Michigan, United States (enrolling)
• McLaren Cancer Institute-Flint — Flint, Michigan, United States (enrolling)
• McLaren Cancer Institute-Lapeer Region — Lapeer, Michigan, United States (enrolling)
• McLaren Cancer Institute-Owosso — Owosso, Michigan, United States (enrolling)
• UM Sylvester Comprehensive Cancer Center at Coral Gables — Coral Gables, Florida, United States (enrolling)
• Corewell Health Dearborn Hospital — Dearborn, Michigan, United States (enrolling)
• UM Sylvester Comprehensive Cancer Center at Deerfield Beach — Deerfield Beach, Florida, United States (enrolling)
• Weisberg Cancer Treatment Center — Farmington Hills, Michigan, United States (enrolling)
• UM Sylvester Comprehensive Cancer Center at Doral — Doral, Florida, United States (enrolling)
• University of Arkansas for Medical Sciences — Little Rock, Arkansas, United States (enrolling)
• University of Miami Miller School of Medicine-Sylvester Cancer Center — Miami, Florida, United States (enrolling)
• McLaren Cancer Institute-Central Michigan — Mount Pleasant, Michigan, United States (enrolling)
• Miami Cancer Institute — Miami, Florida, United States (enrolling)
• Northwestern Medicine Cancer Center Kishwaukee — DeKalb, Illinois, United States (enrolling)
• Northwestern Medicine Cancer Center Delnor — Geneva, Illinois, United States (enrolling)
• UM Sylvester Comprehensive Cancer Center at Kendall — Miami, Florida, United States (enrolling)
• Northwestern Medicine Cancer Center Warrenville — Warrenville, Illinois, United States (enrolling)
• Maryland Proton Treatment Center — Baltimore, Maryland, United States (enrolling)
• University of Maryland/Greenebaum Cancer Center — Baltimore, Maryland, United States (enrolling)
• UM Sylvester Comprehensive Cancer Center at Plantation — Plantation, Florida, United States (enrolling)
• Massachusetts General Hospital Cancer Center — Boston, Massachusetts, United States (enrolling)
• McLaren Cancer Institute-Bay City — Bay City, Michigan, United States (enrolling)
• Corewell Health Beaumont Troy Hospital — Troy, Michigan, United States (enrolling)

Full record on ClinicalTrials.gov

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