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Back|NCT03801876Recruiting
Official Title

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

Phase
Phase 3
Sponsor
NRG Oncology
Enrollment
300
Timeline
Jun 2019 → Dec 2031
About This Study

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.

Eligibility Criteria

Inclusion Criteria

  • 1PRIOR TO STEP 1 REGISTRATION:
  • 2Histologically proven diagnosis of adenocarcinoma or squamous cell carcinoma of the thoracic esophagus or gastroesophageal junction (Siewert I-II)
  • 3Stage I-IVA, excluding T4b, according to the American Joint Committee on Cancer (AJCC) 8th edition based on the following diagnostic workup:
  • 4History/physical examination
  • 5Whole-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
  • 6For patients who DID NOT receive induction chemotherapy, scan must occur within 30 days prior to Step 1 registration
  • 7For patients who DID receive induction chemotherapy, scan must occur:
  • 8Within 30 days after final induction chemotherapy dose; OR
  • 9Within 30 days prior to Step 1 registration
  • 10Note: Patients who had prior endoscopic mucosal resection (EMR) with a diagnosis of AJCC stage I-IVA, excluding T4b, esophageal cancer are eligible
  • 11Surgical consultation to determine whether or not the patient is a candidate for resection after completion of chemoradiation
  • 12Induction 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
  • 13Age ≥ 18
  • 14Zubrod performance status 0, 1, or 2
  • 15Absolute neutrophil count (ANC) (within 30 days prior to Step 1 registration)
  • 16For patients who DID NOT receive induction chemotherapy: ANC ≥ 1,500 cells/mm\^3
  • 17For patients who DID receive induction chemotherapy: ANC ≥ 1,000 cells/mm\^3
  • 18Platelets (within 30 days prior to Step 1 registration)
  • 19For patients who DID NOT receive induction chemotherapy: Platelets ≥ 100,000/uL
  • 20For patients who DID receive induction chemotherapy: Platelets ≥ 75,000/uL
  • 21Hemoglobin ≥ 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)
  • 22Serum 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)
  • 23Total bilirubin ≤ 1.5 x upper limit of normal (ULN) (within 30 days prior to Step 1 registration)
  • 24Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 3 x ULN (within 30 days prior to Step 1 registration)
  • 25Negative pregnancy test (serum or urine) within 14 days prior to Step 1 registration for women of child bearing potential
  • 26The patient or a legally authorized representative must provide study-specific informed consent prior to study entry

Exclusion Criteria

  • 1Cervical esophageal cancers arisen from 15-18 cm from the incisors
  • 2Patients with T4b disease according to the AJCC 8th edition
  • 3Definitive clinical or radiologic evidence of metastatic disease
  • 4Any active malignancy within 2 years of study registration that may alter the course of esophageal cancer treatment
  • 5Prior thoracic radiotherapy that would result in overlap of radiation therapy fields
  • 6Severe, active co-morbidity defined as follows:
  • 7Active uncontrolled infection requiring IV antibiotics at the time of Step 1 registration
  • 8Uncontrolled symptomatic congestive heart failure, unstable angina, or cardiac arrhythmia not controlled by any device or medication at the time of Step 1 registration
  • 9Myocardial infarction within 3 months prior to Step 1 registration
  • 10Pregnant and/or nursing females
  • 11Human 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
  • 12PRIOR TO STEP 2 REGISTRATION:
  • 13Unable to obtain confirmation of payment coverage (insurance or other) for either possible radiation treatment

Locations

92 sites participating in this study

Emory Proton Therapy Center

Atlanta, Georgia 30308

Active, Not Recruiting

Emory University Hospital Midtown

Atlanta, Georgia 30308

Active, Not Recruiting

Emory University Hospital/Winship Cancer Institute

Atlanta, Georgia 30322

Active, Not Recruiting
Data sourced from ClinicalTrials.govView on ClinicalTrials.gov →