Comparing Proton Therapy to Photon Radiation Therapy for Esophageal Cancer

Description

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.

Conditions

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 IIA Esophageal Adenocarcinoma AJCC v8, Clinical Stage IIA Gastroesophageal Junction Adenocarcinoma AJCC v8, Clinical Stage IIB Esophageal Adenocarcinoma AJCC v8, Clinical Stage IIB 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, Pathologic Stage I Esophageal Adenocarcinoma AJCC v8, Pathologic Stage I Esophageal Squamous Cell Carcinoma AJCC v8, Pathologic Stage I Gastroesophageal Junction Adenocarcinoma AJCC v8, Pathologic Stage IA Esophageal Adenocarcinoma AJCC v8, Pathologic Stage IA Esophageal Squamous Cell Carcinoma AJCC v8, Pathologic Stage IA Gastroesophageal Junction Adenocarcinoma AJCC v8, Pathologic Stage IB Esophageal Adenocarcinoma AJCC v8, Pathologic Stage IB Esophageal Squamous Cell Carcinoma AJCC v8, Pathologic Stage IB Gastroesophageal Junction Adenocarcinoma AJCC v8, Pathologic Stage IC Esophageal Adenocarcinoma AJCC v8, Pathologic Stage IC Gastroesophageal Junction Adenocarcinoma AJCC v8, Pathologic Stage II Esophageal Adenocarcinoma AJCC v8, Pathologic Stage II Esophageal Squamous Cell Carcinoma AJCC v8, Pathologic Stage II Gastroesophageal Junction Adenocarcinoma AJCC v8, Pathologic Stage IIA Esophageal Adenocarcinoma AJCC v8, Pathologic Stage IIA Esophageal Squamous Cell Carcinoma AJCC v8, Pathologic Stage IIA Gastroesophageal Junction Adenocarcinoma AJCC v8, Pathologic Stage IIB Esophageal Adenocarcinoma AJCC v8, Pathologic Stage IIB Esophageal Squamous Cell Carcinoma AJCC v8, Pathologic Stage IIB Gastroesophageal Junction Adenocarcinoma AJCC v8, Pathologic Stage III Esophageal Adenocarcinoma AJCC v8, Pathologic Stage III Esophageal Squamous Cell Carcinoma AJCC v8, Pathologic Stage III Gastroesophageal Junction Adenocarcinoma AJCC v8, Pathologic Stage IIIA Esophageal Adenocarcinoma AJCC v8, Pathologic Stage IIIA Esophageal Squamous Cell Carcinoma AJCC v8, Pathologic Stage IIIA Gastroesophageal Junction Adenocarcinoma AJCC v8, Pathologic Stage IIIB Esophageal Adenocarcinoma AJCC v8, Pathologic Stage IIIB Esophageal Squamous Cell Carcinoma AJCC v8, Pathologic Stage IIIB Gastroesophageal Junction Adenocarcinoma AJCC v8, Pathologic Stage IVA Esophageal Adenocarcinoma AJCC v8, Pathologic Stage IVA Esophageal Squamous Cell Carcinoma AJCC v8, Pathologic Stage IVA Gastroesophageal Junction Adenocarcinoma AJCC v8, Postneoadjuvant Therapy Stage I Esophageal Adenocarcinoma AJCC v8, Postneoadjuvant Therapy Stage I Esophageal Squamous Cell Carcinoma AJCC v8, Postneoadjuvant Therapy Stage I Gastroesophageal Junction Adenocarcinoma AJCC v8, Postneoadjuvant Therapy Stage II Esophageal Adenocarcinoma AJCC v8, Postneoadjuvant Therapy Stage II Esophageal Squamous Cell Carcinoma AJCC v8, Postneoadjuvant Therapy Stage II Gastroesophageal Junction Adenocarcinoma AJCC v8, Postneoadjuvant Therapy Stage III Esophageal Adenocarcinoma AJCC v8, Postneoadjuvant Therapy Stage III Esophageal Squamous Cell Carcinoma AJCC v8, Postneoadjuvant Therapy Stage III Gastroesophageal Junction Adenocarcinoma AJCC v8, Postneoadjuvant Therapy Stage IIIA Esophageal Adenocarcinoma AJCC v8, Postneoadjuvant Therapy Stage IIIA Esophageal Squamous Cell Carcinoma AJCC v8, Postneoadjuvant Therapy Stage IIIA Gastroesophageal Junction Adenocarcinoma AJCC v8, Postneoadjuvant Therapy Stage IIIB Esophageal Adenocarcinoma AJCC v8, Postneoadjuvant Therapy Stage IIIB Esophageal Squamous Cell Carcinoma AJCC v8, Postneoadjuvant Therapy Stage IIIB Gastroesophageal Junction Adenocarcinoma AJCC v8, Postneoadjuvant Therapy Stage IVA Esophageal Adenocarcinoma AJCC v8, Postneoadjuvant Therapy Stage IVA Esophageal Squamous Cell Carcinoma AJCC v8, Postneoadjuvant Therapy Stage IVA Gastroesophageal Junction Adenocarcinoma AJCC v8, Thoracic Esophagus Squamous Cell Carcinoma

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Study Overview

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Study Details

Study overview

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.

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

Comparing Proton Therapy to Photon Radiation Therapy for Esophageal Cancer

Condition
Clinical Stage I Esophageal Adenocarcinoma AJCC v8
Intervention / Treatment

-

Contacts and Locations

Phoenix

Mayo Clinic Hospital in Arizona, Phoenix, Arizona, United States, 85054

Scottsdale

Mayo Clinic in Arizona, Scottsdale, Arizona, United States, 85259

Little Rock

University of Arkansas for Medical Sciences, Little Rock, Arkansas, United States, 72205

Coral Gables

UM Sylvester Comprehensive Cancer Center at Coral Gables, Coral Gables, Florida, United States, 33146

Deerfield Beach

UM Sylvester Comprehensive Cancer Center at Deerfield Beach, Deerfield Beach, Florida, United States, 33442

Miami

University of Miami Miller School of Medicine-Sylvester Cancer Center, Miami, Florida, United States, 33136

Miami

Miami Cancer Institute, Miami, Florida, United States, 33176

Orlando

Orlando Health Cancer Institute, Orlando, Florida, United States, 32806

Atlanta

Emory Proton Therapy Center, Atlanta, Georgia, United States, 30308

Atlanta

Emory University Hospital Midtown, Atlanta, Georgia, United States, 30308

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility 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 will be allowed as the induction chemotherapy regimen.
  • * 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
  • * 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

Ages Eligible for Study

18 Years to

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

NRG Oncology,

Steven Lin, PRINCIPAL_INVESTIGATOR, NRG Oncology

Study Record Dates

2031-12-21