Comparing Proton Therapy to Photon Radiation Therapy for Esophageal Cancer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.

ClinicalTrials.gov Identifier: NCT03801876

Recruitment Status : Recruiting

First Posted : January 14, 2019

Last Update Posted : March 28, 2023

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View this study on Beta.ClinicalTrials.gov

Sponsor:

Collaborator:

National Cancer Institute (NCI)

Information provided by (Responsible Party):

NRG Oncology

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.

Condition or disease	Intervention/treatment	Phase
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	Drug: Carboplatin Procedure: Esophagectomy Radiation: Intensity-Modulated Radiation Therapy Drug: Paclitaxel Radiation: Proton Beam Radiation Therapy Other: Quality-of-Life Assessment Other: Questionnaire Administration Drug: FOLFOX regimen Drug: CAPOX regimen Drug: Docetaxel Drug: 5FU	Phase 3

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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.

Study Design

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Study Type :	Interventional (Clinical Trial)
Estimated Enrollment :	300 participants
Allocation:	Randomized
Intervention Model:	Parallel Assignment
Masking:	None (Open Label)
Primary Purpose:	Treatment
Official Title:	Phase III Randomized Trial of Proton Beam Therapy (PBT) Versus Intensity Modulated Photon Radiotherapy (IMRT) for the Treatment of Esophageal Cancer
Actual Study Start Date :	March 15, 2019
Estimated Primary Completion Date :	December 21, 2026
Estimated Study Completion Date :	December 21, 2031

Resource links provided by the National Library of Medicine

Genetic and Rare Diseases Information Center resources: Esophageal Cancer

U.S. FDA Resources

Arms and Interventions

Arm	Intervention/treatment
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.	Drug: Carboplatin Given IV Other Names: Blastocarb Carboplat Carboplatin Hexal Carboplatino Carbosin Carbosol Carbotec CBDCA Displata Ercar JM-8 Nealorin Novoplatinum Paraplatin Paraplatin AQ Paraplatine Platinwas Ribocarbo Procedure: Esophagectomy Undergo esophagectomy Other Name: excision of the esophagus Drug: Paclitaxel Given IV Other Names: Anzatax Asotax Bristaxol Praxel Taxol Taxol Konzentrat Radiation: Proton Beam Radiation Therapy Undergo PBT Other Names: PBRT Proton Radiation Therapy Other: Quality-of-Life Assessment Ancillary studies Other Name: Quality of Life Assessment Other: Questionnaire Administration Ancillary studies Drug: FOLFOX regimen Folinic acid, flurouracil and oxaliplatin Other Name: FOLFOX Drug: CAPOX regimen Capecitabine combined with oxaliplatin Other Names: CAPE-OX OxCap Drug: Docetaxel Chemotherapy Other Name: Taxotere Drug: 5FU Chemotherapy Other Names: 5-FU flurouracil Tolak Fluoroplex Efudex Carac Adrucil
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.	Drug: Carboplatin Given IV Other Names: Blastocarb Carboplat Carboplatin Hexal Carboplatino Carbosin Carbosol Carbotec CBDCA Displata Ercar JM-8 Nealorin Novoplatinum Paraplatin Paraplatin AQ Paraplatine Platinwas Ribocarbo Procedure: Esophagectomy Undergo esophagectomy Other Name: excision of the esophagus Radiation: Intensity-Modulated Radiation Therapy Undergo IMRT Other Names: IMRT Intensity Modulated RT Intensity-Modulated Radiotherapy Drug: Paclitaxel Given IV Other Names: Anzatax Asotax Bristaxol Praxel Taxol Taxol Konzentrat Other: Quality-of-Life Assessment Ancillary studies Other Name: Quality of Life Assessment Other: Questionnaire Administration Ancillary studies Drug: FOLFOX regimen Folinic acid, flurouracil and oxaliplatin Other Name: FOLFOX Drug: CAPOX regimen Capecitabine combined with oxaliplatin Other Names: CAPE-OX OxCap Drug: Docetaxel Chemotherapy Other Name: Taxotere Drug: 5FU Chemotherapy Other Names: 5-FU flurouracil Tolak Fluoroplex Efudex Carac Adrucil

Arm

Intervention/treatment

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.

Drug: Carboplatin

Given IV

Other Names:

Blastocarb
Carboplat
Carboplatin Hexal
Carboplatino
Carbosin
Carbosol
Carbotec
CBDCA
Displata
Ercar
JM-8
Nealorin
Novoplatinum
Paraplatin
Paraplatin AQ
Paraplatine
Platinwas
Ribocarbo

Procedure: Esophagectomy

Undergo esophagectomy

Other Name: excision of the esophagus

Drug: Paclitaxel

Given IV

Other Names:

Anzatax
Asotax
Bristaxol
Praxel
Taxol
Taxol Konzentrat

Radiation: Proton Beam Radiation Therapy

Undergo PBT

Other Names:

PBRT
Proton Radiation Therapy

Other: Quality-of-Life Assessment

Ancillary studies

Other Name: Quality of Life Assessment

Other: Questionnaire Administration

Ancillary studies

Drug: FOLFOX regimen

Folinic acid, flurouracil and oxaliplatin

Other Name: FOLFOX

Drug: CAPOX regimen

Capecitabine combined with oxaliplatin

Other Names:

CAPE-OX
OxCap

Drug: Docetaxel

Chemotherapy

Other Name: Taxotere

Drug: 5FU

Chemotherapy

Other Names:

5-FU
flurouracil
Tolak
Fluoroplex
Efudex
Carac
Adrucil

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.

Drug: Carboplatin

Given IV

Other Names:

Blastocarb
Carboplat
Carboplatin Hexal
Carboplatino
Carbosin
Carbosol
Carbotec
CBDCA
Displata
Ercar
JM-8
Nealorin
Novoplatinum
Paraplatin
Paraplatin AQ
Paraplatine
Platinwas
Ribocarbo

Procedure: Esophagectomy

Undergo esophagectomy

Other Name: excision of the esophagus

Radiation: Intensity-Modulated Radiation Therapy

Undergo IMRT

Other Names:

IMRT
Intensity Modulated RT
Intensity-Modulated Radiotherapy

Drug: Paclitaxel

Given IV

Other Names:

Anzatax
Asotax
Bristaxol
Praxel
Taxol
Taxol Konzentrat

Other: Quality-of-Life Assessment

Ancillary studies

Other Name: Quality of Life Assessment

Other: Questionnaire Administration

Ancillary studies

Drug: FOLFOX regimen

Folinic acid, flurouracil and oxaliplatin

Other Name: FOLFOX

Drug: CAPOX regimen

Capecitabine combined with oxaliplatin

Other Names:

CAPE-OX
OxCap

Drug: Docetaxel

Chemotherapy

Other Name: Taxotere

Drug: 5FU

Chemotherapy

Other Names:

5-FU
flurouracil
Tolak
Fluoroplex
Efudex
Carac
Adrucil

Outcome Measures

Primary Outcome Measures :

Overall survival (OS) [ 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 ]
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 [ Time Frame: From baseline up to 8 years ]
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 [ Time Frame: At time of surgery ]
A Chi-square test will be used to compare the pathologic response rates between the treatment arms.
Grade 4 lymphopenia during chemoradiation [ Time Frame: From the start of chemoradiation to the end of chemoradiation treatment assessed up to 31 days ]
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 [ Time Frame: From the last date of chemoradiation up to 8 weeks post chemoradiation ]
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) [ 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 ]
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) [ 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 ]
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 [ 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 ]
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) [ Time Frame: Assessed up to 8 years ]
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 [ Time Frame: Assessed up to 8 years ]
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.

Eligibility Criteria

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Ages Eligible for Study:	18 Years and older (Adult, Older Adult)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03801876

Locations

Show 77 study locations

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United States, Arizona
Mayo Clinic Hospital in Arizona	Recruiting
Phoenix, Arizona, United States, 85054
Contact: Site Public Contact 855-776-0015
Principal Investigator: Christopher L. Hallemeier
Mayo Clinic in Arizona	Recruiting
Scottsdale, Arizona, United States, 85259
Contact: Site Public Contact 855-776-0015
Principal Investigator: Christopher L. Hallemeier
United States, Florida
UM Sylvester Comprehensive Cancer Center at Coral Gables	Recruiting
Coral Gables, Florida, United States, 33146
Contact: Site Public Contact 305-243-2647
Principal Investigator: Benjamin Spieler
UM Sylvester Comprehensive Cancer Center at Deerfield Beach	Recruiting
Deerfield Beach, Florida, United States, 33442
Contact: Site Public Contact 305-243-2647
Principal Investigator: Benjamin Spieler
University of Miami Miller School of Medicine-Sylvester Cancer Center	Recruiting
Miami, Florida, United States, 33136
Contact: Site Public Contact 305-243-2647
Principal Investigator: Benjamin Spieler
Miami Cancer Institute	Recruiting
Miami, Florida, United States, 33176
Contact: Site Public Contact 786-596-2000
Principal Investigator: Michael D. Chuong
Orlando Health Cancer Institute	Recruiting
Orlando, Florida, United States, 32806
Contact: Site Public Contact 321-841-7246 CancerClinicalTrials@orlandohealth.com
Principal Investigator: Patrick Kelly
United States, Georgia
Emory Proton Therapy Center	Recruiting
Atlanta, Georgia, United States, 30308
Contact: Site Public Contact 404-251-2854 allyson.anderson@emory.edu
Principal Investigator: Mark W. McDonald
Emory University Hospital Midtown	Recruiting
Atlanta, Georgia, United States, 30308
Contact: Site Public Contact 888-946-7447
Principal Investigator: Mark W. McDonald
Emory University Hospital/Winship Cancer Institute	Recruiting
Atlanta, Georgia, United States, 30322
Contact: Site Public Contact 404-778-1868
Principal Investigator: Mark W. McDonald
Emory Saint Joseph's Hospital	Recruiting
Atlanta, Georgia, United States, 30342
Contact: Site Public Contact 404-851-7115
Principal Investigator: Mark W. McDonald
United States, Illinois
Northwestern Medicine Cancer Center Kishwaukee	Recruiting
DeKalb, Illinois, United States, 60115
Contact: Site Public Contact 630-352-5360 Donald.Smith3@nm.org
Principal Investigator: Stephen A. Mihalcik
Northwestern Medicine Cancer Center Delnor	Recruiting
Geneva, Illinois, United States, 60134
Contact: Site Public Contact 630-352-5360 Donald.Smith3@nm.org
Principal Investigator: Stephen A. Mihalcik
Northwestern Medicine Cancer Center Warrenville	Recruiting
Warrenville, Illinois, United States, 60555
Contact: Site Public Contact 630-352-5360 Donald.Smith3@nm.org
Principal Investigator: Stephen A. Mihalcik
United States, Maryland
Maryland Proton Treatment Center	Recruiting
Baltimore, Maryland, United States, 21201
Contact: Site Public Contact 410-369-5226 info@mdproton.com
Principal Investigator: Jason K. Molitoris
University of Maryland/Greenebaum Cancer Center	Recruiting
Baltimore, Maryland, United States, 21201
Contact: Site Public Contact 800-888-8823
Principal Investigator: Jason K. Molitoris
UM Upper Chesapeake Medical Center	Recruiting
Bel Air, Maryland, United States, 21014
Contact: Site Public Contact 443-643-3010
Principal Investigator: Jack J. Hong
United States, Massachusetts
Massachusetts General Hospital Cancer Center	Recruiting
Boston, Massachusetts, United States, 02114
Contact: Site Public Contact 877-726-5130
Principal Investigator: Florence K. Keane
United States, Michigan
McLaren Cancer Institute-Bay City	Recruiting
Bay City, Michigan, United States, 48706
Contact: Site Public Contact 313-576-9790 ctoadmin@karmanos.org
Principal Investigator: Christian C. Hyde
Beaumont Hospital - Dearborn	Recruiting
Dearborn, Michigan, United States, 48124
Contact: Site Public Contact 248-551-7695
Principal Investigator: John M. Robertson
Wayne State University/Karmanos Cancer Institute	Recruiting
Detroit, Michigan, United States, 48201
Contact: Site Public Contact 313-576-9790 ctoadmin@karmanos.org
Principal Investigator: Christian C. Hyde
Weisberg Cancer Treatment Center	Recruiting
Farmington Hills, Michigan, United States, 48334
Contact: Site Public Contact 313-576-9790 ctoadmin@karmanos.org
Principal Investigator: Christian C. Hyde
McLaren Cancer Institute-Flint	Recruiting
Flint, Michigan, United States, 48532
Contact: Site Public Contact 313-576-9790 ctoadmin@karmanos.org
Principal Investigator: Christian C. Hyde
Karmanos Cancer Institute at McLaren Greater Lansing	Recruiting
Lansing, Michigan, United States, 48910
Contact: Site Public Contact 313-576-9790 ctoadmin@karmanos.org
Principal Investigator: Christian C. Hyde
McLaren Cancer Institute-Lapeer Region	Recruiting
Lapeer, Michigan, United States, 48446
Contact: Site Public Contact 313-576-9790 ctoadmin@karmanos.org
Principal Investigator: Christian C. Hyde
McLaren Cancer Institute-Owosso	Recruiting
Owosso, Michigan, United States, 48867
Contact: Site Public Contact 313-576-9790 ctoadmin@karmanos.org
Principal Investigator: Christian C. Hyde
William Beaumont Hospital-Royal Oak	Recruiting
Royal Oak, Michigan, United States, 48073
Contact: Site Public Contact 248-551-7695
Principal Investigator: John M. Robertson
William Beaumont Hospital - Troy	Recruiting
Troy, Michigan, United States, 48085
Contact: Site Public Contact 248-551-7695
Principal Investigator: John M. Robertson
United States, Minnesota
Mayo Clinic Health System in Albert Lea	Active, not recruiting
Albert Lea, Minnesota, United States, 56007
Unity Hospital	Recruiting
Fridley, Minnesota, United States, 55432
Contact: Site Public Contact 952-993-1517 mmcorc@healthpartners.com
Principal Investigator: Charles Shideman
Mayo Clinic Health Systems-Mankato	Active, not recruiting
Mankato, Minnesota, United States, 56001
Minnesota Oncology Hematology PA-Maplewood	Recruiting
Maplewood, Minnesota, United States, 55109
Contact: Site Public Contact 952-993-1517 mmcorc@healthpartners.com
Principal Investigator: Charles Shideman
Hennepin County Medical Center	Recruiting
Minneapolis, Minnesota, United States, 55415
Contact: Site Public Contact 952-993-1517 mmcorc@healthpartners.com
Principal Investigator: Charles Shideman
Mayo Clinic Radiation Therapy-Northfield	Recruiting
Northfield, Minnesota, United States, 55057
Contact: Site Public Contact 855-776-0015
Principal Investigator: Christopher L. Hallemeier
Mayo Clinic in Rochester	Recruiting
Rochester, Minnesota, United States, 55905
Contact: Site Public Contact 855-776-0015
Principal Investigator: Christopher L. Hallemeier
United States, Missouri
Siteman Cancer Center at West County Hospital	Recruiting
Creve Coeur, Missouri, United States, 63141
Contact: Site Public Contact 800-600-3606 info@siteman.wustl.edu
Principal Investigator: Shahed N. Badiyan
Washington University School of Medicine	Recruiting
Saint Louis, Missouri, United States, 63110
Contact: Site Public Contact 800-600-3606 info@siteman.wustl.edu
Principal Investigator: Shahed N. Badiyan
Siteman Cancer Center-South County	Recruiting
Saint Louis, Missouri, United States, 63129
Contact: Site Public Contact 800-600-3606 info@siteman.wustl.edu
Principal Investigator: Shahed N. Badiyan
Siteman Cancer Center at Christian Hospital	Recruiting
Saint Louis, Missouri, United States, 63136
Contact: Site Public Contact 800-600-3606 info@siteman.wustl.edu
Principal Investigator: Shahed N. Badiyan
Siteman Cancer Center at Saint Peters Hospital	Recruiting
Saint Peters, Missouri, United States, 63376
Contact: Site Public Contact 800-600-3606 info@siteman.wustl.edu
Principal Investigator: Shahed N. Badiyan
United States, New Jersey
Memorial Sloan Kettering Basking Ridge	Recruiting
Basking Ridge, New Jersey, United States, 07920
Contact: Site Public Contact 212-639-7592
Principal Investigator: Abraham J. Wu
Memorial Sloan Kettering Monmouth	Recruiting
Middletown, New Jersey, United States, 07748
Contact: Site Public Contact 212-639-7592
Principal Investigator: Abraham J. Wu
Memorial Sloan Kettering Bergen	Recruiting
Montvale, New Jersey, United States, 07645
Contact: Site Public Contact 212-639-7592
Principal Investigator: Abraham J. Wu
United States, New York
Memorial Sloan Kettering Commack	Recruiting
Commack, New York, United States, 11725
Contact: Site Public Contact 212-639-7592
Principal Investigator: Abraham J. Wu
Memorial Sloan Kettering Westchester	Recruiting
Harrison, New York, United States, 10604
Contact: Site Public Contact 212-639-7592
Principal Investigator: Abraham J. Wu
New York Proton Center	Recruiting
New York, New York, United States, 10035
Contact: Site Public Contact 646-968-9031 ichoi@nyproton.com
Principal Investigator: Jehee I. Choi
Memorial Sloan Kettering Cancer Center	Recruiting
New York, New York, United States, 10065
Contact: Site Public Contact 212-639-7592
Principal Investigator: Abraham J. Wu
Memorial Sloan Kettering Nassau	Recruiting
Uniondale, New York, United States, 11553
Contact: Site Public Contact 212-639-7592
Principal Investigator: Abraham J. Wu
United States, Ohio
UHHS-Chagrin Highlands Medical Center	Recruiting
Beachwood, Ohio, United States, 44122
Contact: Site Public Contact 800-641-2422 CTUReferral@UHhospitals.org
Principal Investigator: Jennifer A. Dorth
Geauga Hospital	Recruiting
Chardon, Ohio, United States, 44024
Contact: Site Public Contact 800-641-2422 CTUReferral@UHhospitals.org
Principal Investigator: Jennifer A. Dorth
University of Cincinnati Cancer Center-UC Medical Center	Recruiting
Cincinnati, Ohio, United States, 45219
Contact: Site Public Contact 513-584-7698 cancer@uchealth.com
Principal Investigator: Jordan Kharofa
Case Western Reserve University	Recruiting
Cleveland, Ohio, United States, 44106
Contact: Site Public Contact 800-641-2422 CTUReferral@UHhospitals.org
Principal Investigator: Jennifer A. Dorth
Mercy Cancer Center-Elyria	Suspended
Elyria, Ohio, United States, 44035
UH Seidman Cancer Center at Landerbrook Health Center	Recruiting
Mayfield Heights, Ohio, United States, 44124
Contact: Site Public Contact 800-641-2422 CTUReferral@UHhospitals.org
Principal Investigator: Jennifer A. Dorth
UH Seidman Cancer Center at Lake Health Mentor Campus	Recruiting
Mentor, Ohio, United States, 44060
Contact: Site Public Contact 800-641-2422 CTUReferral@UHhospitals.org
Principal Investigator: Jennifer A. Dorth
UH Seidman Cancer Center at Southwest General Hospital	Recruiting
Middleburg Heights, Ohio, United States, 44130
Contact: Site Public Contact 800-641-2422 CTUReferral@UHhospitals.org
Principal Investigator: Jennifer A. Dorth
University Hospitals Parma Medical Center	Recruiting
Parma, Ohio, United States, 44129
Contact: Site Public Contact 800-641-2422 CTUReferral@UHhospitals.org
Principal Investigator: Jennifer A. Dorth
University Hospitals Portage Medical Center	Recruiting
Ravenna, Ohio, United States, 44266
Contact: Site Public Contact 800-641-2422 CTUReferral@UHhospitals.org
Principal Investigator: Jennifer A. Dorth
UH Seidman Cancer Center at Firelands Regional Medical Center	Recruiting
Sandusky, Ohio, United States, 44870
Contact: Site Public Contact 800-641-2422 CTUReferral@UHhospitals.org
Principal Investigator: Jennifer A. Dorth
University Hospitals Sharon Health Center	Recruiting
Wadsworth, Ohio, United States, 44281
Contact: Site Public Contact 800-641-2422 CTUReferral@UHhospitals.org
Principal Investigator: Jennifer A. Dorth
University of Cincinnati Cancer Center-West Chester	Recruiting
West Chester, Ohio, United States, 45069
Contact: Site Public Contact 513-584-7698 cancer@uchealth.com
Principal Investigator: Jordan Kharofa
UH Seidman Cancer Center at Saint John Medical Center	Recruiting
Westlake, Ohio, United States, 44145
Contact: Site Public Contact 800-641-2422 CTUReferral@UHhospitals.org
Principal Investigator: Jennifer A. Dorth
UHHS-Westlake Medical Center	Recruiting
Westlake, Ohio, United States, 44145
Contact: Site Public Contact 800-641-2422 CTUReferral@UHhospitals.org
Principal Investigator: Jennifer A. Dorth
United States, Oklahoma
University of Oklahoma Health Sciences Center	Recruiting
Oklahoma City, Oklahoma, United States, 73104
Contact: Site Public Contact 405-271-8777 ou-clinical-trials@ouhsc.edu
Principal Investigator: Tyler Gunter
United States, Pennsylvania
University of Pennsylvania/Abramson Cancer Center	Recruiting
Philadelphia, Pennsylvania, United States, 19104
Contact: Site Public Contact 800-474-9892
Principal Investigator: John P. Plastaras
United States, Texas
MD Anderson in The Woodlands	Recruiting
Conroe, Texas, United States, 77384
Contact: Site Public Contact 866-632-6789 askmdanderson@mdanderson.org
Principal Investigator: Saumil Gandhi
M D Anderson Cancer Center	Recruiting
Houston, Texas, United States, 77030
Contact: Site Public Contact 877-632-6789 askmdanderson@mdanderson.org
Principal Investigator: Saumil Gandhi
MD Anderson West Houston	Recruiting
Houston, Texas, United States, 77079
Contact: Site Public Contact 877-632-6789 askmdanderson@mdanderson.org
Principal Investigator: Saumil Gandhi
MD Anderson League City	Recruiting
League City, Texas, United States, 77573
Contact: Site Public Contact 877-632-6789 askmdanderson@mdanderson.org
Principal Investigator: Saumil Gandhi
MD Anderson in Sugar Land	Recruiting
Sugar Land, Texas, United States, 77478
Contact: Site Public Contact 877-632-6789 askmdanderson@mdanderson.org
Principal Investigator: Saumil Gandhi
United States, Utah
Huntsman Cancer Institute/University of Utah	Recruiting
Salt Lake City, Utah, United States, 84112
Contact: Site Public Contact 888-424-2100 cancerinfo@hci.utah.edu
Principal Investigator: Shane Lloyd
United States, Virginia
Inova Alexandria Hospital	Recruiting
Alexandria, Virginia, United States, 22304
Contact: Site Public Contact 703-776-2580 Stephanie.VanBebber@inova.org
Principal Investigator: Avani D. Rao
Inova Schar Cancer Institute	Recruiting
Fairfax, Virginia, United States, 22031
Contact: Site Public Contact 703-720-5210 Stephanie.VanBebber@inova.org
Principal Investigator: Avani D. Rao
Inova Fair Oaks Hospital	Recruiting
Fairfax, Virginia, United States, 22033
Contact: Site Public Contact 703-720-5210 Stephanie.VanBebber@inova.org
Principal Investigator: Avani D. Rao
Inova Loudoun Hospital	Recruiting
Leesburg, Virginia, United States, 20176
Contact: Site Public Contact 703-858-6000 Keary.janet@inova.org
Principal Investigator: Avani D. Rao
United States, Washington
University of Washington Medical Center - Montlake	Recruiting
Seattle, Washington, United States, 98195
Contact: Site Public Contact 800-804-8824
Principal Investigator: Smith Apisarnthanarax
United States, Wisconsin
Mayo Clinic Health System-Eau Claire Clinic	Recruiting
Eau Claire, Wisconsin, United States, 54701
Contact: Site Public Contact 855-776-0015
Principal Investigator: Christopher L. Hallemeier

Sponsors and Collaborators

NRG Oncology

National Cancer Institute (NCI)

Investigators

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Principal Investigator:	Steven Lin	NRG Oncology

More Information

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Responsible Party:	NRG Oncology
ClinicalTrials.gov Identifier:	NCT03801876
Other Study ID Numbers:	NRG-GI006 NCI-2018-03378 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) ) NRG-GI006 ( Other Identifier: NRG Oncology ) NRG-GI006 ( Other Identifier: CTEP ) U10CA180822 ( U.S. NIH Grant/Contract ) U10CA180868 ( U.S. NIH Grant/Contract )
First Posted:	January 14, 2019 Key Record Dates
Last Update Posted:	March 28, 2023
Last Verified:	March 2023

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Studies a U.S. FDA-regulated Drug Product:	No
Studies a U.S. FDA-regulated Device Product:	No

Additional relevant MeSH terms:

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Carcinoma Carcinoma, Squamous Cell Adenocarcinoma Esophageal Neoplasms Esophageal Squamous Cell Carcinoma Neoplasms, Glandular and Epithelial Neoplasms by Histologic Type Neoplasms Neoplasms, Squamous Cell Gastrointestinal Neoplasms Digestive System Neoplasms Neoplasms by Site Head and Neck Neoplasms Digestive System Diseases Esophageal Diseases	Gastrointestinal Diseases Paclitaxel Docetaxel Carboplatin Albumin-Bound Paclitaxel Fluorouracil Antineoplastic Agents, Phytogenic Antineoplastic Agents Tubulin Modulators Antimitotic Agents Mitosis Modulators Molecular Mechanisms of Pharmacological Action Antimetabolites Antimetabolites, Antineoplastic Immunosuppressive Agents

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