Comparing Proton Therapy to Photon Radiation Therapy for Esophageal Cancer
Launched by NRG ONCOLOGY · Jan 9, 2019
Trial Information
Current as of July 01, 2025
Recruiting
Keywords
ClinConnect Summary
This clinical trial is investigating two different types of radiation therapy for patients with esophageal cancer, specifically comparing proton therapy to photon radiation therapy. Proton therapy uses protons, which are particles that can deliver targeted radiation to the tumor while sparing more healthy tissue around it. On the other hand, photon therapy uses high-energy x-rays to achieve a similar goal. Researchers want to find out which treatment works better for patients with stage I to IVA esophageal cancer, which includes specific types like adenocarcinoma and squamous cell carcinoma.
To participate in the trial, patients must have a confirmed diagnosis of these specific types of esophageal cancer and be in stages I to IVA, but not have advanced disease (T4b). They should also be in reasonably good health, with specific blood tests showing their body can handle treatment. Participants can expect to receive either type of radiation therapy and will be closely monitored throughout the study. This trial is currently recruiting patients, so if you or a loved one is interested, it's a great opportunity to explore potential treatment options that could improve outcomes for esophageal cancer.
Gender
ALL
Eligibility criteria
- 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
About Nrg Oncology
NRG Oncology is a prominent clinical trial sponsor dedicated to advancing cancer research through innovative multi-institutional studies. Comprising a collaborative network of leading academic institutions and community hospitals, NRG Oncology focuses on enhancing patient outcomes by conducting rigorous clinical trials that evaluate new treatment strategies and improve existing therapies. With a commitment to scientific excellence and patient-centered care, the organization plays a vital role in shaping the future of oncology by integrating cutting-edge research with clinical practice, ultimately striving to translate findings into meaningful improvements in cancer care.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Cleveland, Ohio, United States
Saint Louis, Missouri, United States
Waconia, Minnesota, United States
Boston, Massachusetts, United States
Little Rock, Arkansas, United States
Oklahoma City, Oklahoma, United States
Knoxville, Tennessee, United States
New York, New York, United States
Houston, Texas, United States
Coon Rapids, Minnesota, United States
Fairfax, Virginia, United States
Troy, Michigan, United States
Minneapolis, Minnesota, United States
Salt Lake City, Utah, United States
Scottsdale, Arizona, United States
Atlanta, Georgia, United States
Baltimore, Maryland, United States
Detroit, Michigan, United States
Philadelphia, Pennsylvania, United States
Fridley, Minnesota, United States
Miami, Florida, United States
Royal Oak, Michigan, United States
Miami, Florida, United States
Orlando, Florida, United States
Rochester, Minnesota, United States
Saint Louis, Missouri, United States
Maplewood, Minnesota, United States
Elyria, Ohio, United States
Alexandria, Virginia, United States
Atlanta, Georgia, United States
Dearborn, Michigan, United States
Springfield, Missouri, United States
Cincinnati, Ohio, United States
Mentor, Ohio, United States
Seattle, Washington, United States
Westlake, Ohio, United States
Warrenville, Illinois, United States
Geneva, Illinois, United States
Bay City, Michigan, United States
Flint, Michigan, United States
Lansing, Michigan, United States
Mankato, Minnesota, United States
Saint Louis, Missouri, United States
Atlanta, Georgia, United States
Bel Air, Maryland, United States
Lapeer, Michigan, United States
Beachwood, Ohio, United States
Chardon, Ohio, United States
Middleburg Heights, Ohio, United States
Parma, Ohio, United States
Sandusky, Ohio, United States
Eau Claire, Wisconsin, United States
Saint Peters, Missouri, United States
Knoxville, Tennessee, United States
Fairfax, Virginia, United States
Sugar Land, Texas, United States
Farmington Hills, Michigan, United States
Mayfield Heights, Ohio, United States
Wadsworth, Ohio, United States
West Chester, Ohio, United States
Commack, New York, United States
Conroe, Texas, United States
Houston, Texas, United States
League City, Texas, United States
Montvale, New Jersey, United States
Harrison, New York, United States
Uniondale, New York, United States
Middletown, New Jersey, United States
Basking Ridge, New Jersey, United States
Creve Coeur, Missouri, United States
Saint Louis, Missouri, United States
Ravenna, Ohio, United States
Atlanta, Georgia, United States
Owosso, Michigan, United States
Albert Lea, Minnesota, United States
Westlake, Ohio, United States
Phoenix, Arizona, United States
Coral Gables, Florida, United States
Deerfield Beach, Florida, United States
Leesburg, Virginia, United States
Baltimore, Maryland, United States
New York, New York, United States
Dekalb, Illinois, United States
Oak Ridge, Tennessee, United States
Northfield, Minnesota, United States
Maryville, Tennessee, United States
Alton, Illinois, United States
Shiloh, Illinois, United States
Knoxville, Tennessee, United States
Avon, Ohio, United States
Royal Oak, Michigan, United States
Dearborn, Michigan, United States
Troy, Michigan, United States
Patients applied
Trial Officials
Steven Lin
Principal Investigator
NRG Oncology
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported
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