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Search / Trial NCT03801876

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.

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

0 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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