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Comparing Proton Therapy to Photon Radiation Therapy for Esophageal Cancer

Primary Purpose

Clinical Stage I Esophageal Adenocarcinoma AJCC v8, Clinical Stage I Esophageal Squamous Cell Carcinoma AJCC v8, Clinical Stage I Gastroesophageal Junction Adenocarcinoma AJCC v8

Status
Recruiting
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
Carboplatin
Esophagectomy
Intensity-Modulated Radiation Therapy
Paclitaxel
Proton Beam Radiation Therapy
Quality-of-Life Assessment
Questionnaire Administration
FOLFOX regimen
CAPOX regimen
Docetaxel
5FU
Sponsored by
NRG Oncology
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Clinical Stage I Esophageal Adenocarcinoma AJCC v8

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Arm Type

Experimental

Active Comparator

Arm Label

Group I (PBT, Chemotherapy, Esophagectomy)

Group II (IMRT, Chemotherapy, Esophagectomy)

Arm Description

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.

Outcomes

Primary Outcome Measures

Overall survival (OS)
Will be estimated by the Kaplan-Meier method. The distributions of OS between treatment arms will be compared using the log rank test.
Incidence of specific grade 3+ cardiopulmonary adverse events (AEs) that are definitely, probably, or possibly related to protocol treatment
Will be assessed using Common Terminology Criteria for Adverse Events (CTCAE) version (v) 5.0. Difference in proportion of defined cardiopulmonary AEs will be analyzed with a chi-squared test.

Secondary Outcome Measures

Pathologic response rate
A Chi-square test will be used to compare the pathologic response rates between the treatment arms.
Grade 4 lymphopenia during chemoradiation
Will be assessed using Common Terminology Criteria for Adverse Events (CTCAE) version (v) 5.0. The proportion of patients experiencing grade 4 lymphopenia during chemoradiation will be compared between treatment arms using a chi-squared test.
Lymphocyte counts
Mean lymphocyte counts at first post chemoradiation follow-up will be compared between treatment arms using a t-test. If the data do not satisfy the normality assumption, a Wilcoxin test may be used instead.
Locoregional failure (LRF)
Will be defined as local/regional recurrence or progression. Will be estimated by the cumulative incidence method, with death as a competing risk. The distribution of LRF estimates between the two arms will be compared using Gray?s test. The Fine-Gray regression model will be used to analyze the effects of factors, in addition to treatment, which may be associated with LRF.
Distant metastatic-free survival (DMFS)
Will be defined as appearance of distant metastasis or death due to any cause. Will be estimated by the Kaplan-Meier method and estimates between the two treatment arms will be compared using the log rank test. The Cox proportional hazard regression model will be used to analyze the effects of factors, in addition to treatment, which may be associated with DMFS.
Progression-free survival
Will be defined as appearance of local/regional/distant failure or death due to any cause. Will be estimated by the Kaplan-Meier method and estimates between the two treatment arms will be compared using the log rank test. The Cox proportional hazard regression model will be used to analyze the effects of factors, in addition to treatment, which may be associated with PFS.
Quality-adjusted life years (QALY)
Will be evaluated and compared using EuroQol five-dimensional questionnaire (EQ-5D) only if the primary endpoint is met.
Cost-benefit economic analysis of treatment
Will be calculated by the visual analog scale (VAS) and index scores form the EQ-5D-5L only be done if primary endpoint is met. Will be compared between treatment arms using a t-test with a 2-sided significance level of 0.05. If there are significant differences, then a cost analysis will be conducted.

Full Information

First Posted
January 3, 2019
Last Updated
September 18, 2023
Sponsor
NRG Oncology
Collaborators
National Cancer Institute (NCI)
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1. Study Identification

Unique Protocol Identification Number
NCT03801876
Brief Title
Comparing Proton Therapy to Photon Radiation Therapy for Esophageal Cancer
Official Title
Phase III Randomized Trial of Proton Beam Therapy (PBT) Versus Intensity Modulated Photon Radiotherapy (IMRT) for the Treatment of Esophageal Cancer
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Recruiting
Study Start Date
March 15, 2019 (Actual)
Primary Completion Date
December 21, 2026 (Anticipated)
Study Completion Date
December 21, 2031 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
NRG Oncology
Collaborators
National Cancer Institute (NCI)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
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

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
300 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Group I (PBT, Chemotherapy, Esophagectomy)
Arm Type
Experimental
Arm Description
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.
Arm Title
Group II (IMRT, Chemotherapy, Esophagectomy)
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Carboplatin
Other Intervention Name(s)
Blastocarb, Carboplat, Carboplatin Hexal, Carboplatino, Carbosin, Carbosol, Carbotec, CBDCA, Displata, Ercar, JM-8, Nealorin, Novoplatinum, Paraplatin, Paraplatin AQ, Paraplatine, Platinwas, Ribocarbo
Intervention Description
Given IV
Intervention Type
Procedure
Intervention Name(s)
Esophagectomy
Other Intervention Name(s)
excision of the esophagus
Intervention Description
Undergo esophagectomy
Intervention Type
Radiation
Intervention Name(s)
Intensity-Modulated Radiation Therapy
Other Intervention Name(s)
IMRT, Intensity Modulated RT, Intensity-Modulated Radiotherapy
Intervention Description
Undergo IMRT
Intervention Type
Drug
Intervention Name(s)
Paclitaxel
Other Intervention Name(s)
Anzatax, Asotax, Bristaxol, Praxel, Taxol, Taxol Konzentrat
Intervention Description
Given IV
Intervention Type
Radiation
Intervention Name(s)
Proton Beam Radiation Therapy
Other Intervention Name(s)
PBRT, Proton Radiation Therapy
Intervention Description
Undergo PBT
Intervention Type
Other
Intervention Name(s)
Quality-of-Life Assessment
Other Intervention Name(s)
Quality of Life Assessment
Intervention Description
Ancillary studies
Intervention Type
Other
Intervention Name(s)
Questionnaire Administration
Intervention Description
Ancillary studies
Intervention Type
Drug
Intervention Name(s)
FOLFOX regimen
Other Intervention Name(s)
FOLFOX
Intervention Description
Folinic acid, flurouracil and oxaliplatin
Intervention Type
Drug
Intervention Name(s)
CAPOX regimen
Other Intervention Name(s)
CAPE-OX, OxCap
Intervention Description
Capecitabine combined with oxaliplatin
Intervention Type
Drug
Intervention Name(s)
Docetaxel
Other Intervention Name(s)
Taxotere
Intervention Description
Chemotherapy
Intervention Type
Drug
Intervention Name(s)
5FU
Other Intervention Name(s)
5-FU, flurouracil, Tolak, Fluoroplex, Efudex, Carac, Adrucil
Intervention Description
Chemotherapy
Primary Outcome Measure Information:
Title
Overall survival (OS)
Description
Will be estimated by the Kaplan-Meier method. The distributions of OS between treatment arms will be compared using the log rank test.
Time Frame
From the date of randomization to the date of death due to any cause or date of last follow-up for patients without an OS event reported. This analysis occurs after 173 deaths; estimated to occur 4 years after accrual completion
Title
Incidence of specific grade 3+ cardiopulmonary adverse events (AEs) that are definitely, probably, or possibly related to protocol treatment
Description
Will be assessed using Common Terminology Criteria for Adverse Events (CTCAE) version (v) 5.0. Difference in proportion of defined cardiopulmonary AEs will be analyzed with a chi-squared test.
Time Frame
From baseline up to 8 years
Secondary Outcome Measure Information:
Title
Pathologic response rate
Description
A Chi-square test will be used to compare the pathologic response rates between the treatment arms.
Time Frame
At time of surgery
Title
Grade 4 lymphopenia during chemoradiation
Description
Will be assessed using Common Terminology Criteria for Adverse Events (CTCAE) version (v) 5.0. The proportion of patients experiencing grade 4 lymphopenia during chemoradiation will be compared between treatment arms using a chi-squared test.
Time Frame
From the start of chemoradiation to the end of chemoradiation treatment assessed up to 31 days
Title
Lymphocyte counts
Description
Mean lymphocyte counts at first post chemoradiation follow-up will be compared between treatment arms using a t-test. If the data do not satisfy the normality assumption, a Wilcoxin test may be used instead.
Time Frame
From the last date of chemoradiation up to 8 weeks post chemoradiation
Title
Locoregional failure (LRF)
Description
Will be defined as local/regional recurrence or progression. Will be estimated by the cumulative incidence method, with death as a competing risk. The distribution of LRF estimates between the two arms will be compared using Gray?s test. The Fine-Gray regression model will be used to analyze the effects of factors, in addition to treatment, which may be associated with LRF.
Time Frame
From the date of randomization to the date of first LRF or date of last follow-up for patients without an LRF event reported, assessed up to 8 years
Title
Distant metastatic-free survival (DMFS)
Description
Will be defined as appearance of distant metastasis or death due to any cause. Will be estimated by the Kaplan-Meier method and estimates between the two treatment arms will be compared using the log rank test. The Cox proportional hazard regression model will be used to analyze the effects of factors, in addition to treatment, which may be associated with DMFS.
Time Frame
From the date of randomization to the date of first DMFS failure or last follow-up for patients without a reported DMFS event, assessed up to 8 years
Title
Progression-free survival
Description
Will be defined as appearance of local/regional/distant failure or death due to any cause. Will be estimated by the Kaplan-Meier method and estimates between the two treatment arms will be compared using the log rank test. The Cox proportional hazard regression model will be used to analyze the effects of factors, in addition to treatment, which may be associated with PFS.
Time Frame
From the date of randomization to the date of first PFS failure or last follow-up for patients without a reported PFS event, assessed up to 8 years
Title
Quality-adjusted life years (QALY)
Description
Will be evaluated and compared using EuroQol five-dimensional questionnaire (EQ-5D) only if the primary endpoint is met.
Time Frame
Assessed up to 8 years
Title
Cost-benefit economic analysis of treatment
Description
Will be calculated by the visual analog scale (VAS) and index scores form the EQ-5D-5L only be done if primary endpoint is met. Will be compared between treatment arms using a t-test with a 2-sided significance level of 0.05. If there are significant differences, then a cost analysis will be conducted.
Time Frame
Assessed up to 8 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Steven Lin
Organizational Affiliation
NRG Oncology
Official's Role
Principal Investigator
Facility Information:
Facility Name
Mayo Clinic Hospital in Arizona
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85054
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Public Contact
Phone
855-776-0015
First Name & Middle Initial & Last Name & Degree
Christopher L. Hallemeier
Facility Name
Mayo Clinic in Arizona
City
Scottsdale
State/Province
Arizona
ZIP/Postal Code
85259
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Public Contact
Phone
855-776-0015
First Name & Middle Initial & Last Name & Degree
Christopher L. Hallemeier
Facility Name
UM Sylvester Comprehensive Cancer Center at Coral Gables
City
Coral Gables
State/Province
Florida
ZIP/Postal Code
33146
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Public Contact
Phone
305-243-2647
First Name & Middle Initial & Last Name & Degree
Benjamin Spieler
Facility Name
UM Sylvester Comprehensive Cancer Center at Deerfield Beach
City
Deerfield Beach
State/Province
Florida
ZIP/Postal Code
33442
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Public Contact
Phone
305-243-2647
First Name & Middle Initial & Last Name & Degree
Benjamin Spieler
Facility Name
University of Miami Miller School of Medicine-Sylvester Cancer Center
City
Miami
State/Province
Florida
ZIP/Postal Code
33136
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Public Contact
Phone
305-243-2647
First Name & Middle Initial & Last Name & Degree
Benjamin Spieler
Facility Name
Miami Cancer Institute
City
Miami
State/Province
Florida
ZIP/Postal Code
33176
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Public Contact
Phone
786-596-2000
First Name & Middle Initial & Last Name & Degree
Michael D. Chuong
Facility Name
Orlando Health Cancer Institute
City
Orlando
State/Province
Florida
ZIP/Postal Code
32806
Country
United States
Individual Site Status
Active, not recruiting
Facility Name
Emory Proton Therapy Center
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30308
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Public Contact
Phone
404-251-2854
Email
allyson.anderson@emory.edu
First Name & Middle Initial & Last Name & Degree
Mark W. McDonald
Facility Name
Emory University Hospital Midtown
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30308
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Public Contact
Phone
888-946-7447
First Name & Middle Initial & Last Name & Degree
Mark W. McDonald
Facility Name
Emory University Hospital/Winship Cancer Institute
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30322
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Public Contact
Phone
404-778-1868
First Name & Middle Initial & Last Name & Degree
Mark W. McDonald
Facility Name
Emory Saint Joseph's Hospital
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30342
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Public Contact
Phone
404-851-7115
First Name & Middle Initial & Last Name & Degree
Mark W. McDonald
Facility Name
Alton Memorial Hospital
City
Alton
State/Province
Illinois
ZIP/Postal Code
62002
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Public Contact
Phone
618-463-7323
First Name & Middle Initial & Last Name & Degree
Gregory R. Vlacich
Facility Name
Northwestern Medicine Cancer Center Kishwaukee
City
DeKalb
State/Province
Illinois
ZIP/Postal Code
60115
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Public Contact
Phone
630-352-5360
Email
Donald.Smith3@nm.org
First Name & Middle Initial & Last Name & Degree
Stephen A. Mihalcik
Facility Name
Northwestern Medicine Cancer Center Delnor
City
Geneva
State/Province
Illinois
ZIP/Postal Code
60134
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Public Contact
Phone
630-352-5360
Email
Donald.Smith3@nm.org
First Name & Middle Initial & Last Name & Degree
Stephen A. Mihalcik
Facility Name
Memorial Hospital East
City
Shiloh
State/Province
Illinois
ZIP/Postal Code
62269
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Public Contact
Phone
314-747-9912
Email
dschwab@wustl.edu
First Name & Middle Initial & Last Name & Degree
Gregory R. Vlacich
Facility Name
Northwestern Medicine Cancer Center Warrenville
City
Warrenville
State/Province
Illinois
ZIP/Postal Code
60555
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Public Contact
Phone
630-352-5360
Email
Donald.Smith3@nm.org
First Name & Middle Initial & Last Name & Degree
Stephen A. Mihalcik
Facility Name
Maryland Proton Treatment Center
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21201
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Public Contact
Phone
410-369-5226
Email
info@mdproton.com
First Name & Middle Initial & Last Name & Degree
Jason K. Molitoris
Facility Name
University of Maryland/Greenebaum Cancer Center
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21201
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Public Contact
Phone
800-888-8823
First Name & Middle Initial & Last Name & Degree
Jason K. Molitoris
Facility Name
UM Upper Chesapeake Medical Center
City
Bel Air
State/Province
Maryland
ZIP/Postal Code
21014
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Public Contact
Phone
443-643-3010
First Name & Middle Initial & Last Name & Degree
Jack J. Hong
Facility Name
Massachusetts General Hospital Cancer Center
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02114
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Public Contact
Phone
877-726-5130
First Name & Middle Initial & Last Name & Degree
Florence K. Keane
Facility Name
McLaren Cancer Institute-Bay City
City
Bay City
State/Province
Michigan
ZIP/Postal Code
48706
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Public Contact
Phone
313-576-9790
Email
ctoadmin@karmanos.org
First Name & Middle Initial & Last Name & Degree
Christian C. Hyde
Facility Name
Beaumont Hospital - Dearborn
City
Dearborn
State/Province
Michigan
ZIP/Postal Code
48124
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Public Contact
Phone
248-551-7695
First Name & Middle Initial & Last Name & Degree
John M. Robertson
Facility Name
Wayne State University/Karmanos Cancer Institute
City
Detroit
State/Province
Michigan
ZIP/Postal Code
48201
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Public Contact
Phone
313-576-9790
Email
ctoadmin@karmanos.org
First Name & Middle Initial & Last Name & Degree
Christian C. Hyde
Facility Name
Weisberg Cancer Treatment Center
City
Farmington Hills
State/Province
Michigan
ZIP/Postal Code
48334
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Public Contact
Phone
313-576-9790
Email
ctoadmin@karmanos.org
First Name & Middle Initial & Last Name & Degree
Christian C. Hyde
Facility Name
McLaren Cancer Institute-Flint
City
Flint
State/Province
Michigan
ZIP/Postal Code
48532
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Public Contact
Phone
313-576-9790
Email
ctoadmin@karmanos.org
First Name & Middle Initial & Last Name & Degree
Christian C. Hyde
Facility Name
Karmanos Cancer Institute at McLaren Greater Lansing
City
Lansing
State/Province
Michigan
ZIP/Postal Code
48910
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Public Contact
Phone
313-576-9790
Email
ctoadmin@karmanos.org
First Name & Middle Initial & Last Name & Degree
Christian C. Hyde
Facility Name
McLaren Cancer Institute-Lapeer Region
City
Lapeer
State/Province
Michigan
ZIP/Postal Code
48446
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Public Contact
Phone
313-576-9790
Email
ctoadmin@karmanos.org
First Name & Middle Initial & Last Name & Degree
Christian C. Hyde
Facility Name
McLaren Cancer Institute-Owosso
City
Owosso
State/Province
Michigan
ZIP/Postal Code
48867
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Public Contact
Phone
313-576-9790
Email
ctoadmin@karmanos.org
First Name & Middle Initial & Last Name & Degree
Christian C. Hyde
Facility Name
William Beaumont Hospital-Royal Oak
City
Royal Oak
State/Province
Michigan
ZIP/Postal Code
48073
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Public Contact
Phone
248-551-7695
First Name & Middle Initial & Last Name & Degree
John M. Robertson
Facility Name
William Beaumont Hospital - Troy
City
Troy
State/Province
Michigan
ZIP/Postal Code
48085
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Public Contact
Phone
248-551-7695
First Name & Middle Initial & Last Name & Degree
John M. Robertson
Facility Name
Mayo Clinic Health System in Albert Lea
City
Albert Lea
State/Province
Minnesota
ZIP/Postal Code
56007
Country
United States
Individual Site Status
Active, not recruiting
Facility Name
Unity Hospital
City
Fridley
State/Province
Minnesota
ZIP/Postal Code
55432
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Public Contact
Phone
952-993-1517
Email
mmcorc@healthpartners.com
First Name & Middle Initial & Last Name & Degree
Charles Shideman
Facility Name
Mayo Clinic Health Systems-Mankato
City
Mankato
State/Province
Minnesota
ZIP/Postal Code
56001
Country
United States
Individual Site Status
Active, not recruiting
Facility Name
Minnesota Oncology Hematology PA-Maplewood
City
Maplewood
State/Province
Minnesota
ZIP/Postal Code
55109
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Public Contact
Phone
952-993-1517
Email
mmcorc@healthpartners.com
First Name & Middle Initial & Last Name & Degree
Charles Shideman
Facility Name
Hennepin County Medical Center
City
Minneapolis
State/Province
Minnesota
ZIP/Postal Code
55415
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Public Contact
Phone
952-993-1517
Email
mmcorc@healthpartners.com
First Name & Middle Initial & Last Name & Degree
Charles Shideman
Facility Name
Mayo Clinic Radiation Therapy-Northfield
City
Northfield
State/Province
Minnesota
ZIP/Postal Code
55057
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Public Contact
Phone
855-776-0015
First Name & Middle Initial & Last Name & Degree
Christopher L. Hallemeier
Facility Name
Mayo Clinic in Rochester
City
Rochester
State/Province
Minnesota
ZIP/Postal Code
55905
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Public Contact
Phone
855-776-0015
First Name & Middle Initial & Last Name & Degree
Christopher L. Hallemeier
Facility Name
Siteman Cancer Center at West County Hospital
City
Creve Coeur
State/Province
Missouri
ZIP/Postal Code
63141
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Public Contact
Phone
800-600-3606
Email
info@siteman.wustl.edu
First Name & Middle Initial & Last Name & Degree
Gregory R. Vlacich
Facility Name
Washington University School of Medicine
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63110
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Public Contact
Phone
800-600-3606
Email
info@siteman.wustl.edu
First Name & Middle Initial & Last Name & Degree
Gregory R. Vlacich
Facility Name
Siteman Cancer Center-South County
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63129
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Public Contact
Phone
800-600-3606
Email
info@siteman.wustl.edu
First Name & Middle Initial & Last Name & Degree
Gregory R. Vlacich
Facility Name
Siteman Cancer Center at Christian Hospital
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63136
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Public Contact
Phone
800-600-3606
Email
info@siteman.wustl.edu
First Name & Middle Initial & Last Name & Degree
Gregory R. Vlacich
Facility Name
Siteman Cancer Center at Saint Peters Hospital
City
Saint Peters
State/Province
Missouri
ZIP/Postal Code
63376
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Public Contact
Phone
800-600-3606
Email
info@siteman.wustl.edu
First Name & Middle Initial & Last Name & Degree
Gregory R. Vlacich
Facility Name
Memorial Sloan Kettering Basking Ridge
City
Basking Ridge
State/Province
New Jersey
ZIP/Postal Code
07920
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Public Contact
Phone
212-639-7592
First Name & Middle Initial & Last Name & Degree
Abraham J. Wu
Facility Name
Memorial Sloan Kettering Monmouth
City
Middletown
State/Province
New Jersey
ZIP/Postal Code
07748
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Public Contact
Phone
212-639-7592
First Name & Middle Initial & Last Name & Degree
Abraham J. Wu
Facility Name
Memorial Sloan Kettering Bergen
City
Montvale
State/Province
New Jersey
ZIP/Postal Code
07645
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Public Contact
Phone
212-639-7592
First Name & Middle Initial & Last Name & Degree
Abraham J. Wu
Facility Name
Memorial Sloan Kettering Commack
City
Commack
State/Province
New York
ZIP/Postal Code
11725
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Public Contact
Phone
212-639-7592
First Name & Middle Initial & Last Name & Degree
Abraham J. Wu
Facility Name
Memorial Sloan Kettering Westchester
City
Harrison
State/Province
New York
ZIP/Postal Code
10604
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Public Contact
Phone
212-639-7592
First Name & Middle Initial & Last Name & Degree
Abraham J. Wu
Facility Name
New York Proton Center
City
New York
State/Province
New York
ZIP/Postal Code
10035
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Public Contact
Phone
646-968-9031
Email
ichoi@nyproton.com
First Name & Middle Initial & Last Name & Degree
Jehee I. Choi
Facility Name
Memorial Sloan Kettering Cancer Center
City
New York
State/Province
New York
ZIP/Postal Code
10065
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Public Contact
Phone
212-639-7592
First Name & Middle Initial & Last Name & Degree
Abraham J. Wu
Facility Name
Memorial Sloan Kettering Nassau
City
Uniondale
State/Province
New York
ZIP/Postal Code
11553
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Public Contact
Phone
212-639-7592
First Name & Middle Initial & Last Name & Degree
Abraham J. Wu
Facility Name
UHHS-Chagrin Highlands Medical Center
City
Beachwood
State/Province
Ohio
ZIP/Postal Code
44122
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Public Contact
Phone
800-641-2422
Email
CTUReferral@UHhospitals.org
First Name & Middle Initial & Last Name & Degree
Jennifer A. Dorth
Facility Name
Geauga Hospital
City
Chardon
State/Province
Ohio
ZIP/Postal Code
44024
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Public Contact
Phone
800-641-2422
Email
CTUReferral@UHhospitals.org
First Name & Middle Initial & Last Name & Degree
Jennifer A. Dorth
Facility Name
University of Cincinnati Cancer Center-UC Medical Center
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45219
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Public Contact
Phone
513-584-7698
Email
cancer@uchealth.com
First Name & Middle Initial & Last Name & Degree
Jordan Kharofa
Facility Name
Case Western Reserve University
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44106
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Public Contact
Phone
800-641-2422
Email
CTUReferral@UHhospitals.org
First Name & Middle Initial & Last Name & Degree
Jennifer A. Dorth
Facility Name
Mercy Cancer Center-Elyria
City
Elyria
State/Province
Ohio
ZIP/Postal Code
44035
Country
United States
Individual Site Status
Suspended
Facility Name
UH Seidman Cancer Center at Landerbrook Health Center
City
Mayfield Heights
State/Province
Ohio
ZIP/Postal Code
44124
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Public Contact
Phone
800-641-2422
Email
CTUReferral@UHhospitals.org
First Name & Middle Initial & Last Name & Degree
Jennifer A. Dorth
Facility Name
UH Seidman Cancer Center at Lake Health Mentor Campus
City
Mentor
State/Province
Ohio
ZIP/Postal Code
44060
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Public Contact
Phone
800-641-2422
Email
CTUReferral@UHhospitals.org
First Name & Middle Initial & Last Name & Degree
Jennifer A. Dorth
Facility Name
UH Seidman Cancer Center at Southwest General Hospital
City
Middleburg Heights
State/Province
Ohio
ZIP/Postal Code
44130
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Public Contact
Phone
800-641-2422
Email
CTUReferral@UHhospitals.org
First Name & Middle Initial & Last Name & Degree
Jennifer A. Dorth
Facility Name
University Hospitals Parma Medical Center
City
Parma
State/Province
Ohio
ZIP/Postal Code
44129
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Public Contact
Phone
800-641-2422
Email
CTUReferral@UHhospitals.org
First Name & Middle Initial & Last Name & Degree
Jennifer A. Dorth
Facility Name
University Hospitals Portage Medical Center
City
Ravenna
State/Province
Ohio
ZIP/Postal Code
44266
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Public Contact
Phone
800-641-2422
Email
CTUReferral@UHhospitals.org
First Name & Middle Initial & Last Name & Degree
Jennifer A. Dorth
Facility Name
UH Seidman Cancer Center at Firelands Regional Medical Center
City
Sandusky
State/Province
Ohio
ZIP/Postal Code
44870
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Public Contact
Phone
800-641-2422
Email
CTUReferral@UHhospitals.org
First Name & Middle Initial & Last Name & Degree
Jennifer A. Dorth
Facility Name
University Hospitals Sharon Health Center
City
Wadsworth
State/Province
Ohio
ZIP/Postal Code
44281
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Public Contact
Phone
800-641-2422
Email
CTUReferral@UHhospitals.org
First Name & Middle Initial & Last Name & Degree
Jennifer A. Dorth
Facility Name
University of Cincinnati Cancer Center-West Chester
City
West Chester
State/Province
Ohio
ZIP/Postal Code
45069
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Public Contact
Phone
513-584-7698
Email
cancer@uchealth.com
First Name & Middle Initial & Last Name & Degree
Jordan Kharofa
Facility Name
UH Seidman Cancer Center at Saint John Medical Center
City
Westlake
State/Province
Ohio
ZIP/Postal Code
44145
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Public Contact
Phone
800-641-2422
Email
CTUReferral@UHhospitals.org
First Name & Middle Initial & Last Name & Degree
Jennifer A. Dorth
Facility Name
UHHS-Westlake Medical Center
City
Westlake
State/Province
Ohio
ZIP/Postal Code
44145
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Public Contact
Phone
800-641-2422
Email
CTUReferral@UHhospitals.org
First Name & Middle Initial & Last Name & Degree
Jennifer A. Dorth
Facility Name
University of Oklahoma Health Sciences Center
City
Oklahoma City
State/Province
Oklahoma
ZIP/Postal Code
73104
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Public Contact
Phone
405-271-8777
Email
ou-clinical-trials@ouhsc.edu
First Name & Middle Initial & Last Name & Degree
Tyler Gunter
Facility Name
University of Pennsylvania/Abramson Cancer Center
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Public Contact
Phone
800-474-9892
First Name & Middle Initial & Last Name & Degree
John P. Plastaras
Facility Name
Thompson Proton Center
City
Knoxville
State/Province
Tennessee
ZIP/Postal Code
37909
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Public Contact
Phone
865-531-5118
Email
jwilso31@covhlth.com
First Name & Middle Initial & Last Name & Degree
Grant M. Clark
Facility Name
Thompson Cancer Survival Center
City
Knoxville
State/Province
Tennessee
ZIP/Postal Code
37916
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Public Contact
Phone
865-331-1812
First Name & Middle Initial & Last Name & Degree
Grant M. Clark
Facility Name
Thompson Cancer Survival Center - West
City
Knoxville
State/Province
Tennessee
ZIP/Postal Code
37932
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Public Contact
Phone
865-331-1812
First Name & Middle Initial & Last Name & Degree
Grant M. Clark
Facility Name
Thompson Oncology Group-Maryville
City
Maryville
State/Province
Tennessee
ZIP/Postal Code
37804
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Public Contact
Phone
865-331-1812
First Name & Middle Initial & Last Name & Degree
Grant M. Clark
Facility Name
Thompson Oncology Group-Oak Ridge
City
Oak Ridge
State/Province
Tennessee
ZIP/Postal Code
37830
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Public Contact
Phone
865-331-1812
First Name & Middle Initial & Last Name & Degree
Grant M. Clark
Facility Name
MD Anderson in The Woodlands
City
Conroe
State/Province
Texas
ZIP/Postal Code
77384
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Public Contact
Phone
866-632-6789
Email
askmdanderson@mdanderson.org
First Name & Middle Initial & Last Name & Degree
Saumil Gandhi
Facility Name
M D Anderson Cancer Center
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Public Contact
Phone
877-632-6789
Email
askmdanderson@mdanderson.org
First Name & Middle Initial & Last Name & Degree
Saumil Gandhi
Facility Name
MD Anderson West Houston
City
Houston
State/Province
Texas
ZIP/Postal Code
77079
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Public Contact
Phone
877-632-6789
Email
askmdanderson@mdanderson.org
First Name & Middle Initial & Last Name & Degree
Saumil Gandhi
Facility Name
MD Anderson League City
City
League City
State/Province
Texas
ZIP/Postal Code
77573
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Public Contact
Phone
877-632-6789
Email
askmdanderson@mdanderson.org
First Name & Middle Initial & Last Name & Degree
Saumil Gandhi
Facility Name
MD Anderson in Sugar Land
City
Sugar Land
State/Province
Texas
ZIP/Postal Code
77478
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Public Contact
Phone
877-632-6789
Email
askmdanderson@mdanderson.org
First Name & Middle Initial & Last Name & Degree
Saumil Gandhi
Facility Name
Huntsman Cancer Institute/University of Utah
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84112
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Public Contact
Phone
888-424-2100
Email
cancerinfo@hci.utah.edu
First Name & Middle Initial & Last Name & Degree
Shane Lloyd
Facility Name
Inova Alexandria Hospital
City
Alexandria
State/Province
Virginia
ZIP/Postal Code
22304
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Public Contact
Phone
703-776-2580
Email
Stephanie.VanBebber@inova.org
First Name & Middle Initial & Last Name & Degree
Avani D. Rao
Facility Name
Inova Schar Cancer Institute
City
Fairfax
State/Province
Virginia
ZIP/Postal Code
22031
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Public Contact
Phone
703-720-5210
Email
Stephanie.VanBebber@inova.org
First Name & Middle Initial & Last Name & Degree
Avani D. Rao
Facility Name
Inova Fair Oaks Hospital
City
Fairfax
State/Province
Virginia
ZIP/Postal Code
22033
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Public Contact
Phone
703-720-5210
Email
Stephanie.VanBebber@inova.org
First Name & Middle Initial & Last Name & Degree
Avani D. Rao
Facility Name
Inova Loudoun Hospital
City
Leesburg
State/Province
Virginia
ZIP/Postal Code
20176
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Public Contact
Phone
703-858-6000
Email
Keary.janet@inova.org
First Name & Middle Initial & Last Name & Degree
Avani D. Rao
Facility Name
University of Washington Medical Center - Montlake
City
Seattle
State/Province
Washington
ZIP/Postal Code
98195
Country
United States
Individual Site Status
Active, not recruiting
Facility Name
Mayo Clinic Health System-Eau Claire Clinic
City
Eau Claire
State/Province
Wisconsin
ZIP/Postal Code
54701
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Public Contact
Phone
855-776-0015
First Name & Middle Initial & Last Name & Degree
Christopher L. Hallemeier

12. IPD Sharing Statement

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Comparing Proton Therapy to Photon Radiation Therapy for Esophageal Cancer

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