Comparing Proton Therapy to Photon Radiation Therapy for Esophageal Cancer
Clinical Stage I Esophageal Adenocarcinoma AJCC v8, Clinical Stage I Esophageal Squamous Cell Carcinoma AJCC v8, Clinical Stage I Gastroesophageal Junction Adenocarcinoma AJCC v8
About this trial
This is an interventional treatment trial for Clinical Stage I Esophageal Adenocarcinoma AJCC v8
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
Sites / Locations
- Mayo Clinic Hospital in ArizonaRecruiting
- Mayo Clinic in ArizonaRecruiting
- UM Sylvester Comprehensive Cancer Center at Coral GablesRecruiting
- UM Sylvester Comprehensive Cancer Center at Deerfield BeachRecruiting
- University of Miami Miller School of Medicine-Sylvester Cancer CenterRecruiting
- Miami Cancer InstituteRecruiting
- Orlando Health Cancer Institute
- Emory Proton Therapy CenterRecruiting
- Emory University Hospital MidtownRecruiting
- Emory University Hospital/Winship Cancer InstituteRecruiting
- Emory Saint Joseph's HospitalRecruiting
- Alton Memorial HospitalRecruiting
- Northwestern Medicine Cancer Center KishwaukeeRecruiting
- Northwestern Medicine Cancer Center DelnorRecruiting
- Memorial Hospital EastRecruiting
- Northwestern Medicine Cancer Center WarrenvilleRecruiting
- Maryland Proton Treatment CenterRecruiting
- University of Maryland/Greenebaum Cancer CenterRecruiting
- UM Upper Chesapeake Medical CenterRecruiting
- Massachusetts General Hospital Cancer CenterRecruiting
- McLaren Cancer Institute-Bay CityRecruiting
- Beaumont Hospital - DearbornRecruiting
- Wayne State University/Karmanos Cancer InstituteRecruiting
- Weisberg Cancer Treatment CenterRecruiting
- McLaren Cancer Institute-FlintRecruiting
- Karmanos Cancer Institute at McLaren Greater LansingRecruiting
- McLaren Cancer Institute-Lapeer RegionRecruiting
- McLaren Cancer Institute-OwossoRecruiting
- William Beaumont Hospital-Royal OakRecruiting
- William Beaumont Hospital - TroyRecruiting
- Mayo Clinic Health System in Albert Lea
- Unity HospitalRecruiting
- Mayo Clinic Health Systems-Mankato
- Minnesota Oncology Hematology PA-MaplewoodRecruiting
- Hennepin County Medical CenterRecruiting
- Mayo Clinic Radiation Therapy-NorthfieldRecruiting
- Mayo Clinic in RochesterRecruiting
- Siteman Cancer Center at West County HospitalRecruiting
- Washington University School of MedicineRecruiting
- Siteman Cancer Center-South CountyRecruiting
- Siteman Cancer Center at Christian HospitalRecruiting
- Siteman Cancer Center at Saint Peters HospitalRecruiting
- Memorial Sloan Kettering Basking RidgeRecruiting
- Memorial Sloan Kettering MonmouthRecruiting
- Memorial Sloan Kettering BergenRecruiting
- Memorial Sloan Kettering CommackRecruiting
- Memorial Sloan Kettering WestchesterRecruiting
- New York Proton CenterRecruiting
- Memorial Sloan Kettering Cancer CenterRecruiting
- Memorial Sloan Kettering NassauRecruiting
- UHHS-Chagrin Highlands Medical CenterRecruiting
- Geauga HospitalRecruiting
- University of Cincinnati Cancer Center-UC Medical CenterRecruiting
- Case Western Reserve UniversityRecruiting
- Mercy Cancer Center-Elyria
- UH Seidman Cancer Center at Landerbrook Health CenterRecruiting
- UH Seidman Cancer Center at Lake Health Mentor CampusRecruiting
- UH Seidman Cancer Center at Southwest General HospitalRecruiting
- University Hospitals Parma Medical CenterRecruiting
- University Hospitals Portage Medical CenterRecruiting
- UH Seidman Cancer Center at Firelands Regional Medical CenterRecruiting
- University Hospitals Sharon Health CenterRecruiting
- University of Cincinnati Cancer Center-West ChesterRecruiting
- UH Seidman Cancer Center at Saint John Medical CenterRecruiting
- UHHS-Westlake Medical CenterRecruiting
- University of Oklahoma Health Sciences CenterRecruiting
- University of Pennsylvania/Abramson Cancer CenterRecruiting
- Thompson Proton CenterRecruiting
- Thompson Cancer Survival CenterRecruiting
- Thompson Cancer Survival Center - WestRecruiting
- Thompson Oncology Group-MaryvilleRecruiting
- Thompson Oncology Group-Oak RidgeRecruiting
- MD Anderson in The WoodlandsRecruiting
- M D Anderson Cancer CenterRecruiting
- MD Anderson West HoustonRecruiting
- MD Anderson League CityRecruiting
- MD Anderson in Sugar LandRecruiting
- Huntsman Cancer Institute/University of UtahRecruiting
- Inova Alexandria HospitalRecruiting
- Inova Schar Cancer InstituteRecruiting
- Inova Fair Oaks HospitalRecruiting
- Inova Loudoun HospitalRecruiting
- University of Washington Medical Center - Montlake
- Mayo Clinic Health System-Eau Claire ClinicRecruiting
Arms of the Study
Arm 1
Arm 2
Experimental
Active Comparator
Group I (PBT, Chemotherapy, Esophagectomy)
Group II (IMRT, Chemotherapy, Esophagectomy)
Patients undergo PBT over 28 fractions 5 days a week for 5.5 weeks to a total dose of 50.4 Gy. Patients also receive chemotherapy (Choice of 3 regimens: 1. Carboplatin/Paclitaxel, 2. FOLFOX/CAPOX or 3. Docetaxel/5-FU [with capecitabine as an acceptable substitute for 5-FU]) per institutional standards while undergoing PBT. Within 4-8 weeks after completion of chemotherapy and radiation therapy, patients may undergo an esophagectomy per physician discretion.
Patients undergo IMRT over 28 fractions 5 days a week for 5.5 weeks to a total dose of 50.4 Gy. Patients also receive chemotherapy (Choice of 3 regimens: 1. Carboplatin/Paclitaxel, 2. FOLFOX/CAPOX or 3. Docetaxel/5-FU [with capecitabine as an acceptable substitute for 5-FU]) per institutional standards while undergoing IMRT. Within 4-8 weeks after completion of chemotherapy and radiation therapy, patients may undergo an esophagectomy per physician discretion.