RECRUITING
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Comparing Proton Therapy to Photon Radiation Therapy for Esophageal Cancer
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
More conditions available...
🗓️ Study Start (Actual) 15 March 2019
🗓️ Primary Completion (Estimated) 21 December 2026
✅ Study Completion (Estimated) 21 December 2031
👥 Enrollment (Estimated) 300
🔬 Study Type INTERVENTIONAL
📊 Phase PHASE3
Locations:
📍 Phoenix, Arizona, United States
📍 Scottsdale, Arizona, United States
📍 Coral Gables, Florida, United States
📍 Deerfield Beach, Florida, United States
📍 Miami, Florida, United States
📍 Miami, Florida, United States
📍 Orlando, Florida, United States
📍 Atlanta, Georgia, United States
📍 Atlanta, Georgia, United States
📍 Atlanta, Georgia, United States
📍 Atlanta, Georgia, United States
📍 Alton, Illinois, United States
📍 DeKalb, Illinois, United States
📍 Geneva, Illinois, United States
📍 Shiloh, Illinois, United States
📍 Warrenville, Illinois, United States
📍 Baltimore, Maryland, United States
📍 Baltimore, Maryland, United States
📍 Bel Air, Maryland, United States
📍 Boston, Massachusetts, United States
📍 Bay City, Michigan, United States
📍 Dearborn, Michigan, United States
📍 Detroit, Michigan, United States
📍 Farmington Hills, Michigan, United States
📍 Flint, Michigan, United States
📍 Lansing, Michigan, United States
📍 Lapeer, Michigan, United States
📍 Owosso, Michigan, United States
📍 Royal Oak, Michigan, United States
📍 Troy, Michigan, United States
📍 Albert Lea, Minnesota, United States
📍 Coon Rapids, Minnesota, United States
📍 Fridley, Minnesota, United States
📍 Mankato, Minnesota, United States
📍 Maplewood, Minnesota, United States
📍 Minneapolis, Minnesota, United States
📍 Northfield, Minnesota, United States
📍 Rochester, Minnesota, United States
📍 Creve Coeur, Missouri, United States
📍 Saint Louis, Missouri, United States
📍 Saint Louis, Missouri, United States
📍 Saint Louis, Missouri, United States
📍 Saint Peters, Missouri, United States
📍 Basking Ridge, New Jersey, United States
📍 Middletown, New Jersey, United States
📍 Montvale, New Jersey, United States
📍 Commack, New York, United States
📍 Harrison, New York, United States
📍 New York, New York, United States
📍 New York, New York, United States
📍 Uniondale, New York, United States
📍 Avon, Ohio, United States
📍 Beachwood, Ohio, United States
📍 Chardon, Ohio, United States
📍 Cincinnati, Ohio, United States
📍 Cleveland, Ohio, United States
📍 Elyria, Ohio, United States
📍 Mayfield Heights, Ohio, United States
📍 Mentor, Ohio, United States
📍 Middleburg Heights, Ohio, United States
📍 Parma, Ohio, United States
📍 Ravenna, Ohio, United States
📍 Sandusky, Ohio, United States
📍 Wadsworth, Ohio, United States
📍 West Chester, Ohio, United States
📍 Westlake, Ohio, United States
📍 Westlake, Ohio, United States
📍 Oklahoma City, Oklahoma, United States
📍 Philadelphia, Pennsylvania, United States
📍 Knoxville, Tennessee, United States
📍 Knoxville, Tennessee, United States
📍 Knoxville, Tennessee, United States
📍 Maryville, Tennessee, United States
📍 Oak Ridge, Tennessee, United States
📍 Conroe, Texas, United States
📍 Houston, Texas, United States
📍 Houston, Texas, United States
📍 League City, Texas, United States
📍 Sugar Land, Texas, United States
📍 Salt Lake City, Utah, United States
📍 Alexandria, Virginia, United States
📍 Fairfax, Virginia, United States
📍 Fairfax, Virginia, United States
📍 Leesburg, Virginia, United States
📍 Seattle, Washington, United States
📍 Eau Claire, Wisconsin, United States
More locations available...

📋 Eligibility Criteria

Description

    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 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

    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
Ages Eligible for Study: 18 Years to N/A (ADULT, OLDER_ADULT)
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers: No

🗓️ Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

  • First Submitted 3 January 2019
  • First Submitted that Met QC Criteria 9 January 2019
  • First Posted 14 January 2019

Study Record Updates

  • Last Update Submitted that Met QC Criteria 5 February 2024
  • Last Update Posted 7 February 2024
  • Last Verified February 2024
I'm interested ...!!