Comparing Proton Therapy to Photon Radiation Therapy for Esophageal Cancer
Purpose
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.
Conditions
- Clinical Stage I Esophageal Adenocarcinoma AJCC v8
- Clinical Stage I Esophageal Squamous Cell Carcinoma AJCC v8
- Clinical Stage I Gastroesophageal Junction Adenocarcinoma AJCC v8
- Clinical Stage II Esophageal Adenocarcinoma AJCC v8
- Clinical Stage II Esophageal Squamous Cell Carcinoma AJCC v8
- Clinical Stage II Gastroesophageal Junction Adenocarcinoma AJCC v8
- Clinical Stage IIA Esophageal Adenocarcinoma AJCC v8
- Clinical Stage IIA Gastroesophageal Junction Adenocarcinoma AJCC v8
- Clinical Stage IIB Esophageal Adenocarcinoma AJCC v8
- Clinical Stage IIB Gastroesophageal Junction Adenocarcinoma AJCC v8
- Clinical Stage III Esophageal Adenocarcinoma AJCC v8
- Clinical Stage III Esophageal Squamous Cell Carcinoma AJCC v8
- Clinical Stage III Gastroesophageal Junction Adenocarcinoma AJCC v8
- Clinical Stage IVA Esophageal Adenocarcinoma AJCC v8
- Clinical Stage IVA Esophageal Squamous Cell Carcinoma AJCC v8
- Clinical Stage IVA Gastroesophageal Junction Adenocarcinoma AJCC v8
- Pathologic Stage I Esophageal Adenocarcinoma AJCC v8
- Pathologic Stage I Esophageal Squamous Cell Carcinoma AJCC v8
- Pathologic Stage I Gastroesophageal Junction Adenocarcinoma AJCC v8
- Pathologic Stage IA Esophageal Adenocarcinoma AJCC v8
- Pathologic Stage IA Esophageal Squamous Cell Carcinoma AJCC v8
- Pathologic Stage IA Gastroesophageal Junction Adenocarcinoma AJCC v8
- Pathologic Stage IB Esophageal Adenocarcinoma AJCC v8
- Pathologic Stage IB Esophageal Squamous Cell Carcinoma AJCC v8
- Pathologic Stage IB Gastroesophageal Junction Adenocarcinoma AJCC v8
- Pathologic Stage IC Esophageal Adenocarcinoma AJCC v8
- Pathologic Stage IC Gastroesophageal Junction Adenocarcinoma AJCC v8
- Pathologic Stage II Esophageal Adenocarcinoma AJCC v8
- Pathologic Stage II Esophageal Squamous Cell Carcinoma AJCC v8
- Pathologic Stage II Gastroesophageal Junction Adenocarcinoma AJCC v8
- Pathologic Stage IIA Esophageal Adenocarcinoma AJCC v8
- Pathologic Stage IIA Esophageal Squamous Cell Carcinoma AJCC v8
- Pathologic Stage IIA Gastroesophageal Junction Adenocarcinoma AJCC v8
- Pathologic Stage IIB Esophageal Adenocarcinoma AJCC v8
- Pathologic Stage IIB Esophageal Squamous Cell Carcinoma AJCC v8
- Pathologic Stage IIB Gastroesophageal Junction Adenocarcinoma AJCC v8
- Pathologic Stage III Esophageal Adenocarcinoma AJCC v8
- Pathologic Stage III Esophageal Squamous Cell Carcinoma AJCC v8
- Pathologic Stage III Gastroesophageal Junction Adenocarcinoma AJCC v8
- Pathologic Stage IIIA Esophageal Adenocarcinoma AJCC v8
- Pathologic Stage IIIA Esophageal Squamous Cell Carcinoma AJCC v8
- Pathologic Stage IIIA Gastroesophageal Junction Adenocarcinoma AJCC v8
- Pathologic Stage IIIB Esophageal Adenocarcinoma AJCC v8
- Pathologic Stage IIIB Esophageal Squamous Cell Carcinoma AJCC v8
- Pathologic Stage IIIB Gastroesophageal Junction Adenocarcinoma AJCC v8
- Pathologic Stage IVA Esophageal Adenocarcinoma AJCC v8
- Pathologic Stage IVA Esophageal Squamous Cell Carcinoma AJCC v8
- Pathologic Stage IVA Gastroesophageal Junction Adenocarcinoma AJCC v8
- Postneoadjuvant Therapy Stage I Esophageal Adenocarcinoma AJCC v8
- Postneoadjuvant Therapy Stage I Esophageal Squamous Cell Carcinoma AJCC v8
- Postneoadjuvant Therapy Stage I Gastroesophageal Junction Adenocarcinoma AJCC v8
- Postneoadjuvant Therapy Stage II Esophageal Adenocarcinoma AJCC v8
- Postneoadjuvant Therapy Stage II Esophageal Squamous Cell Carcinoma AJCC v8
- Postneoadjuvant Therapy Stage II Gastroesophageal Junction Adenocarcinoma AJCC v8
- Postneoadjuvant Therapy Stage III Esophageal Adenocarcinoma AJCC v8
- Postneoadjuvant Therapy Stage III Esophageal Squamous Cell Carcinoma AJCC v8
- Postneoadjuvant Therapy Stage III Gastroesophageal Junction Adenocarcinoma AJCC v8
- Postneoadjuvant Therapy Stage IIIA Esophageal Adenocarcinoma AJCC v8
- Postneoadjuvant Therapy Stage IIIA Esophageal Squamous Cell Carcinoma AJCC v8
- Postneoadjuvant Therapy Stage IIIA Gastroesophageal Junction Adenocarcinoma AJCC v8
- Postneoadjuvant Therapy Stage IIIB Esophageal Adenocarcinoma AJCC v8
- Postneoadjuvant Therapy Stage IIIB Esophageal Squamous Cell Carcinoma AJCC v8
- Postneoadjuvant Therapy Stage IIIB Gastroesophageal Junction Adenocarcinoma AJCC v8
- Postneoadjuvant Therapy Stage IVA Esophageal Adenocarcinoma AJCC v8
- Postneoadjuvant Therapy Stage IVA Esophageal Squamous Cell Carcinoma AJCC v8
- Postneoadjuvant Therapy Stage IVA Gastroesophageal Junction Adenocarcinoma AJCC v8
- Thoracic Esophagus Squamous Cell Carcinoma
Eligibility
- Eligible Ages
- Over 18 Years
- Eligible Sex
- All
- Accepts Healthy Volunteers
- No
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
Study Design
- Phase
- Phase 3
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel Assignment
- Primary Purpose
- Treatment
- Masking
- None (Open Label)
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
|
Experimental Group I (PBT, 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. |
|
|
Active Comparator Group II (IMRT, Chemotherapy, Esophagectomy) |
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. |
|
Recruiting Locations
Mayo Clinic Hospital in Arizona
Phoenix 5308655, Arizona 5551752 85054
Phoenix 5308655, Arizona 5551752 85054
Contact:
Site Public Contact
855-776-0015
Site Public Contact
855-776-0015
University of Arkansas for Medical Sciences
Little Rock 4119403, Arkansas 4099753 72205
Little Rock 4119403, Arkansas 4099753 72205
Contact:
Site Public Contact
501-686-8274
Site Public Contact
501-686-8274
UM Sylvester Comprehensive Cancer Center at Coral Gables
Coral Gables 4151871, Florida 4155751 33146
Coral Gables 4151871, Florida 4155751 33146
Contact:
Site Public Contact
305-243-2647
Site Public Contact
305-243-2647
UM Sylvester Comprehensive Cancer Center at Deerfield Beach
Deerfield Beach 4153071, Florida 4155751 33442
Deerfield Beach 4153071, Florida 4155751 33442
Contact:
Site Public Contact
305-243-2647
Site Public Contact
305-243-2647
University of Miami Miller School of Medicine-Sylvester Cancer Center
Miami 4164138, Florida 4155751 33136
Miami 4164138, Florida 4155751 33136
Contact:
Site Public Contact
305-243-2647
Site Public Contact
305-243-2647
Miami Cancer Institute
Miami 4164138, Florida 4155751 33176
Miami 4164138, Florida 4155751 33176
Contact:
Site Public Contact
786-596-2000
Site Public Contact
786-596-2000
Alton Memorial Hospital
Alton 4232679, Illinois 4896861 62002
Alton 4232679, Illinois 4896861 62002
Contact:
Site Public Contact
618-463-7323
Site Public Contact
618-463-7323
Northwestern Medicine Cancer Center Kishwaukee
DeKalb 4889553, Illinois 4896861 60115
DeKalb 4889553, Illinois 4896861 60115
Northwestern Medicine Cancer Center Delnor
Geneva 4893591, Illinois 4896861 60134
Geneva 4893591, Illinois 4896861 60134
Memorial Hospital East
Shiloh 4249910, Illinois 4896861 62269
Shiloh 4249910, Illinois 4896861 62269
Northwestern Medicine Cancer Center Warrenville
Warrenville 4915525, Illinois 4896861 60555
Warrenville 4915525, Illinois 4896861 60555
Maryland Proton Treatment Center
Baltimore 4347778, Maryland 4361885 21201
Baltimore 4347778, Maryland 4361885 21201
University of Maryland/Greenebaum Cancer Center
Baltimore 4347778, Maryland 4361885 21201
Baltimore 4347778, Maryland 4361885 21201
Contact:
Site Public Contact
800-888-8823
Site Public Contact
800-888-8823
UM Upper Chesapeake Medical Center
Bel Air 4348240, Maryland 4361885 21014
Bel Air 4348240, Maryland 4361885 21014
Contact:
Site Public Contact
443-643-3010
Site Public Contact
443-643-3010
Massachusetts General Hospital Cancer Center
Boston 4930956, Massachusetts 6254926 02114
Boston 4930956, Massachusetts 6254926 02114
Contact:
Site Public Contact
877-726-5130
Site Public Contact
877-726-5130
McLaren Cancer Institute-Bay City
Bay City 4985180, Michigan 5001836 48706
Bay City 4985180, Michigan 5001836 48706
Corewell Health Dearborn Hospital
Dearborn 4990510, Michigan 5001836 48124
Dearborn 4990510, Michigan 5001836 48124
Contact:
Site Public Contact
248-551-7695
Site Public Contact
248-551-7695
Wayne State University/Karmanos Cancer Institute
Detroit 4990729, Michigan 5001836 48201
Detroit 4990729, Michigan 5001836 48201
Weisberg Cancer Treatment Center
Farmington Hills 4992523, Michigan 5001836 48334
Farmington Hills 4992523, Michigan 5001836 48334
McLaren Cancer Institute-Flint
Flint 4992982, Michigan 5001836 48532
Flint 4992982, Michigan 5001836 48532
Karmanos Cancer Institute at McLaren Greater Lansing
Lansing 4998830, Michigan 5001836 48910
Lansing 4998830, Michigan 5001836 48910
McLaren Cancer Institute-Lapeer Region
Lapeer 4998842, Michigan 5001836 48446
Lapeer 4998842, Michigan 5001836 48446
McLaren Cancer Institute-Owosso
Owosso 5004792, Michigan 5001836 48867
Owosso 5004792, Michigan 5001836 48867
Corewell Health William Beaumont University Hospital
Royal Oak 5007804, Michigan 5001836 48073
Royal Oak 5007804, Michigan 5001836 48073
Contact:
Site Public Contact
248-551-7695
Site Public Contact
248-551-7695
Corewell Health Beaumont Troy Hospital
Troy 5012639, Michigan 5001836 48085
Troy 5012639, Michigan 5001836 48085
Contact:
Site Public Contact
248-551-7695
Site Public Contact
248-551-7695
Mercy Hospital
Coon Rapids 5022025, Minnesota 5037779 55433
Coon Rapids 5022025, Minnesota 5037779 55433
Minnesota Oncology Hematology PA-Maplewood
Maplewood 5036588, Minnesota 5037779 55109
Maplewood 5036588, Minnesota 5037779 55109
Hennepin County Medical Center
Minneapolis 5037649, Minnesota 5037779 55415
Minneapolis 5037649, Minnesota 5037779 55415
Mayo Clinic Radiation Therapy-Northfield
Northfield 5039675, Minnesota 5037779 55057
Northfield 5039675, Minnesota 5037779 55057
Contact:
Site Public Contact
855-776-0015
Site Public Contact
855-776-0015
Ridgeview Medical Center
Waconia 5051640, Minnesota 5037779 55387
Waconia 5051640, Minnesota 5037779 55387
Siteman Cancer Center at Saint Peters Hospital
City of Saint Peters 4407237, Missouri 4398678 63376
City of Saint Peters 4407237, Missouri 4398678 63376
Siteman Cancer Center at West County Hospital
Creve Coeur 4382837, Missouri 4398678 63141
Creve Coeur 4382837, Missouri 4398678 63141
Mercy Hospital Springfield
Springfield 4409896, Missouri 4398678 65804
Springfield 4409896, Missouri 4398678 65804
Contact:
Site Public Contact
417-269-4520
Site Public Contact
417-269-4520
Washington University School of Medicine
St Louis 4407066, Missouri 4398678 63110
St Louis 4407066, Missouri 4398678 63110
Siteman Cancer Center-South County
St Louis 4407066, Missouri 4398678 63129
St Louis 4407066, Missouri 4398678 63129
Siteman Cancer Center at Christian Hospital
St Louis 4407066, Missouri 4398678 63136
St Louis 4407066, Missouri 4398678 63136
Mercy Hospital Saint Louis
St Louis 4407066, Missouri 4398678 63141
St Louis 4407066, Missouri 4398678 63141
Contact:
Site Public Contact
314-251-7066
Site Public Contact
314-251-7066
Memorial Sloan Kettering Basking Ridge
Basking Ridge 5095409, New Jersey 5101760 07920
Basking Ridge 5095409, New Jersey 5101760 07920
Contact:
Site Public Contact
212-639-7592
Site Public Contact
212-639-7592
Memorial Sloan Kettering Monmouth
Middletown 5101170, New Jersey 5101760 07748
Middletown 5101170, New Jersey 5101760 07748
Contact:
Site Public Contact
212-639-7592
Site Public Contact
212-639-7592
Memorial Sloan Kettering Bergen
Montvale 5101361, New Jersey 5101760 07645
Montvale 5101361, New Jersey 5101760 07645
Contact:
Site Public Contact
212-639-7592
Site Public Contact
212-639-7592
Memorial Sloan Kettering Commack
Commack 5113412, New York 5128638 11725
Commack 5113412, New York 5128638 11725
Contact:
Site Public Contact
212-639-7592
Site Public Contact
212-639-7592
Memorial Sloan Kettering Westchester
Harrison 5120095, New York 5128638 10604
Harrison 5120095, New York 5128638 10604
Contact:
Site Public Contact
212-639-7592
Site Public Contact
212-639-7592
New York Proton Center
New York 5128581, New York 5128638 10035
New York 5128581, New York 5128638 10035
Memorial Sloan Kettering Cancer Center
New York 5128581, New York 5128638 10065
New York 5128581, New York 5128638 10065
Contact:
Site Public Contact
212-639-7592
Site Public Contact
212-639-7592
Memorial Sloan Kettering Nassau
Uniondale 5141927, New York 5128638 11553
Uniondale 5141927, New York 5128638 11553
Contact:
Site Public Contact
212-639-7592
Site Public Contact
212-639-7592
UH Seidman Cancer Center at UH Avon Health Center
Avon 5146277, Ohio 5165418 44011
Avon 5146277, Ohio 5165418 44011
Contact:
Site Public Contact
800-641-2422
Site Public Contact
800-641-2422
UHHS-Chagrin Highlands Medical Center
Beachwood 5146711, Ohio 5165418 44122
Beachwood 5146711, Ohio 5165418 44122
Geauga Hospital
Chardon 5149818, Ohio 5165418 44024
Chardon 5149818, Ohio 5165418 44024
University of Cincinnati Cancer Center-UC Medical Center
Cincinnati 4508722, Ohio 5165418 45219
Cincinnati 4508722, Ohio 5165418 45219
Case Western Reserve University
Cleveland 5150529, Ohio 5165418 44106
Cleveland 5150529, Ohio 5165418 44106
UH Seidman Cancer Center at Landerbrook Health Center
Mayfield Heights 5162188, Ohio 5165418 44124
Mayfield Heights 5162188, Ohio 5165418 44124
UH Seidman Cancer Center at Lake Health Mentor Campus
Mentor 5162645, Ohio 5165418 44060
Mentor 5162645, Ohio 5165418 44060
UH Seidman Cancer Center at Southwest General Hospital
Middleburg Heights 5162851, Ohio 5165418 44130
Middleburg Heights 5162851, Ohio 5165418 44130
University Hospitals Parma Medical Center
Parma 5166177, Ohio 5165418 44129
Parma 5166177, Ohio 5165418 44129
University Hospitals Portage Medical Center
Ravenna 5167737, Ohio 5165418 44266
Ravenna 5167737, Ohio 5165418 44266
UH Seidman Cancer Center at Firelands Regional Medical Center
Sandusky 5170691, Ohio 5165418 44870
Sandusky 5170691, Ohio 5165418 44870
University Hospitals Sharon Health Center
Wadsworth 5175496, Ohio 5165418 44281
Wadsworth 5175496, Ohio 5165418 44281
University of Cincinnati Cancer Center-West Chester
West Chester 4520522, Ohio 5165418 45069
West Chester 4520522, Ohio 5165418 45069
UHHS-Westlake Medical Center
Westlake 5176517, Ohio 5165418 44145
Westlake 5176517, Ohio 5165418 44145
University of Oklahoma Health Sciences Center
Oklahoma City 4544349, Oklahoma 4544379 73104
Oklahoma City 4544349, Oklahoma 4544379 73104
University of Pennsylvania/Abramson Cancer Center
Philadelphia 4560349, Pennsylvania 6254927 19104
Philadelphia 4560349, Pennsylvania 6254927 19104
Thompson Proton Center
Knoxville 4634946, Tennessee 4662168 37909
Knoxville 4634946, Tennessee 4662168 37909
Thompson Cancer Survival Center
Knoxville 4634946, Tennessee 4662168 37916
Knoxville 4634946, Tennessee 4662168 37916
Contact:
Site Public Contact
865-331-1812
Site Public Contact
865-331-1812
Thompson Cancer Survival Center - West
Knoxville 4634946, Tennessee 4662168 37932
Knoxville 4634946, Tennessee 4662168 37932
Contact:
Site Public Contact
865-331-1812
Site Public Contact
865-331-1812
Thompson Oncology Group-Oak Ridge
Oak Ridge 4646571, Tennessee 4662168 37830
Oak Ridge 4646571, Tennessee 4662168 37830
Contact:
Site Public Contact
865-331-1812
Site Public Contact
865-331-1812
MD Anderson in The Woodlands
Conroe 4682991, Texas 4736286 77384
Conroe 4682991, Texas 4736286 77384
M D Anderson Cancer Center
Houston 4699066, Texas 4736286 77030
Houston 4699066, Texas 4736286 77030
MD Anderson West Houston
Houston 4699066, Texas 4736286 77079
Houston 4699066, Texas 4736286 77079
MD Anderson League City
League City 4705692, Texas 4736286 77573
League City 4705692, Texas 4736286 77573
MD Anderson in Sugar Land
Sugar Land 4734825, Texas 4736286 77478
Sugar Land 4734825, Texas 4736286 77478
Huntsman Cancer Institute/University of Utah
Salt Lake City 5780993, Utah 5549030 84112
Salt Lake City 5780993, Utah 5549030 84112
More Details
- NCT ID
- NCT03801876
- Status
- Recruiting
- Sponsor
- NRG Oncology
Detailed Description
PRIMARY OBJECTIVES: I. To determine if overall survival (OS) is improved with proton beam radiation therapy (PBT) treatment as compared to intensity modulated photon radiation therapy (IMRT) as part of planned protocol treatment for patients with esophageal cancer. II. To determine if OS with PBT is non-inferior to IMRT as part of planned protocol treatment and that there will be less grade 3+ cardiopulmonary toxicity with PBT than with IMRT. SECONDARY OBJECTIVES: I. To compare the symptom burden and impact on functioning of patients between treatment modalities based on Patient Reported Outcome (PRO) measures of symptoms using MD Anderson Symptom Inventory (MDASI) and Patient-Reported Outcomes Measurement Information System (PROMIS)-Fatigue. II. To compare the Quality-Adjusted Life Years (QALY) using EuroQol five-dimensional questionnaire (EQ5D) as a health outcome between PBT and IMRT, if the protocol primary endpoint is met. III. To assess the pathologic response rate between PBT and IMRT. IV. To assess the cost-benefit economic analysis of treatment between radiation modalities. V. To compare the length of hospitalization after protocol surgery between PBT and IMRT. VI. To compare the incidence of grade 4 lymphopenia during chemoradiation between PBT and IMRT. VII. To compare lymphocyte nadir at first follow-up visit after completion of chemoradiation between PBT & IMRT. VIII. To estimate the locoregional failure, distant metastatic free survival, and progression-free survival of patients treated with PBT versus IMRT. IX. To compare incidence of both early (< 90 days from treatment start) and late (≥ 90 days from treatment start) cardiovascular and pulmonary events between PBT versus IMRT. X. To compare the Total Toxicity Burden (TTB) of IMRT versus PBT based on a composite index of 9 individual cardiopulmonary toxicities. EXPLORATORY OBJECTIVES: I. To collect biospecimens for future analyses, for example to assess cardiac and inflammatory biomarkers in association with treatment complications. OUTLINE: Patients are randomized to 1 of 2 groups. GROUP I: Patients undergo PBT over 28 fractions 5 days a week for 5.5 weeks. Patients also receive paclitaxel intravenously (IV) and carboplatin IV on days 1, 8, 15, 22, 29, and 36 while undergoing PBT. GROUP II: Patients undergo IMRT over 28 fractions 5 days a week for 5.5 weeks. Patients also receive paclitaxel IV and carboplatin IV on days 1, 8, 15, 22, 29, and 36 while undergoing IMRT. In both groups, within 4-8 weeks after completion of chemotherapy and radiation therapy, patients may undergo an esophagectomy per physician discretion. After completion of study treatment, patients are followed up every 3-6 months for 3 years and then annually thereafter.