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