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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT03801876
Other study ID # NRG-GI006
Secondary ID NCI-2018-03378NR
Status Recruiting
Phase Phase 3
First received
Last updated
Start date March 15, 2019
Est. completion date December 21, 2031

Study information

Verified date February 2024
Source NRG Oncology
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Recruiting
Enrollment 300
Est. completion date December 21, 2031
Est. primary completion date December 21, 2026
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - PRIOR TO STEP 1 REGISTRATION: - Histologically proven diagnosis of adenocarcinoma or squamous cell carcinoma of the thoracic esophagus or gastroesophageal junction (Siewert I-II) - Stage I-IVA, excluding T4b, according to the American Joint Committee on Cancer (AJCC) 8th edition based on the following diagnostic workup: - History/physical examination - Whole-body fludeoxyglucose F-18 (FDG)-positron emission tomography (PET)/computed tomography (CT) with or without (+/-) contrast (preferred) or chest/abdominal (include pelvic if clinically indicated) CT with contrast - For patients who DID NOT receive induction chemotherapy, scan must occur within 30 days prior to Step 1 registration - For patients who DID receive induction chemotherapy, scan must occur: - Within 30 days after final induction chemotherapy dose; OR - Within 30 days prior to Step 1 registration - Note: Patients who had prior endoscopic mucosal resection (EMR) with a diagnosis of AJCC stage I-IVA, excluding T4b, esophageal cancer are eligible - Surgical consultation to determine whether or not the patient is a candidate for resection after completion of chemoradiation - Induction chemotherapy for the current malignancy prior to concurrent chemoradiation allowed if last dose is no more than 90 days and no less than 10 days prior to Step 1 registration. Only FOLFOX will be allowed as the induction chemotherapy regimen. - Zubrod performance status 0, 1, or 2 - Absolute neutrophil count (ANC) (within 30 days prior to Step 1 registration) - For patients who DID NOT receive induction chemotherapy: ANC >= 1,500 cells/mm^3 - For patients who DID receive induction chemotherapy: ANC >= 1,000 cells/mm^3 - Platelets (within 30 days prior to Step 1 registration) - For patients who DID NOT receive induction chemotherapy: Platelets >= 100,000/uL - For patients who DID receive induction chemotherapy: Platelets >= 75,000/uL - Hemoglobin >= 8.0 g/dl (Note: The use of transfusion or other intervention to achieve Hgb >= 8.0 g/dl is acceptable) (within 30 days prior to Step 1 registration) - Serum creatinine = 1.5 x upper limit of normal (ULN) or Creatinine clearance > 40 mL/min estimated by Cockcroft-Gault formula (within 30 days prior to Step 1 registration) - Total bilirubin =< 1.5 x upper limit of normal (ULN) (within 30 days prior to Step 1 registration) - Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) =< 3 x ULN (within 30 days prior to Step 1 registration) - Negative pregnancy test (serum or urine) within 14 days prior to Step 1 registration for women of child bearing potential - The patient or a legally authorized representative must provide study-specific informed consent prior to study entry Exclusion Criteria: - Cervical esophageal cancers arisen from 15-18 cm from the incisors - Patients with T4b disease according to the AJCC 8th edition - Definitive clinical or radiologic evidence of metastatic disease - Any active malignancy within 2 years of study registration that may alter the course of esophageal cancer treatment - Prior thoracic radiotherapy that would result in overlap of radiation therapy fields - Severe, active co-morbidity defined as follows: - Active uncontrolled infection requiring IV antibiotics at the time of Step 1 registration - Uncontrolled symptomatic congestive heart failure, unstable angina, or cardiac arrhythmia not controlled by any device or medication at the time of Step 1 registration - Myocardial infarction within 3 months prior to Step 1 registration - Pregnant and/or nursing females - Human immunodeficiency virus (HIV) positive with CD4 count < 200 cells/microliter. Note that patients who are HIV positive are eligible, provided they are under treatment with highly active antiretroviral therapy (HAART) and have a CD4 count >= 200 cells/microliter within 30 days prior to registration. Note also that HIV testing is not required for eligibility for this protocol. This exclusion criterion is necessary because the treatments involved in this protocol may be significantly immunosuppressive - PRIOR TO STEP 2 REGISTRATION: - Unable to obtain confirmation of payment coverage (insurance or other) for either possible radiation treatment

Study Design


Related Conditions & MeSH terms

  • Adenocarcinoma
  • Carcinoma
  • Carcinoma, Squamous Cell
  • 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
  • Esophageal Neoplasms
  • Esophageal Squamous Cell Carcinoma
  • 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

Intervention

Drug:
Carboplatin
Given IV
Procedure:
Esophagectomy
Undergo esophagectomy
Radiation:
Intensity-Modulated Radiation Therapy
Undergo IMRT
Drug:
Paclitaxel
Given IV
Radiation:
Proton Beam Radiation Therapy
Undergo PBT
Other:
Quality-of-Life Assessment
Ancillary studies
Questionnaire Administration
Ancillary studies
Drug:
FOLFOX regimen
Folinic acid, flurouracil and oxaliplatin
CAPOX regimen
Capecitabine combined with oxaliplatin
Docetaxel
Chemotherapy
5FU
Chemotherapy

Locations

Country Name City State
United States Mayo Clinic Health System in Albert Lea Albert Lea Minnesota
United States Inova Alexandria Hospital Alexandria Virginia
United States Alton Memorial Hospital Alton Illinois
United States Emory Proton Therapy Center Atlanta Georgia
United States Emory Saint Joseph's Hospital Atlanta Georgia
United States Emory University Hospital Midtown Atlanta Georgia
United States Emory University Hospital/Winship Cancer Institute Atlanta Georgia
United States UH Seidman Cancer Center at UH Avon Health Center Avon Ohio
United States Maryland Proton Treatment Center Baltimore Maryland
United States University of Maryland/Greenebaum Cancer Center Baltimore Maryland
United States Memorial Sloan Kettering Basking Ridge Basking Ridge New Jersey
United States McLaren Cancer Institute-Bay City Bay City Michigan
United States UHHS-Chagrin Highlands Medical Center Beachwood Ohio
United States UM Upper Chesapeake Medical Center Bel Air Maryland
United States Massachusetts General Hospital Cancer Center Boston Massachusetts
United States Geauga Hospital Chardon Ohio
United States University of Cincinnati Cancer Center-UC Medical Center Cincinnati Ohio
United States Case Western Reserve University Cleveland Ohio
United States Memorial Sloan Kettering Commack Commack New York
United States MD Anderson in The Woodlands Conroe Texas
United States Mercy Hospital Coon Rapids Minnesota
United States UM Sylvester Comprehensive Cancer Center at Coral Gables Coral Gables Florida
United States Siteman Cancer Center at West County Hospital Creve Coeur Missouri
United States Beaumont Hospital - Dearborn Dearborn Michigan
United States UM Sylvester Comprehensive Cancer Center at Deerfield Beach Deerfield Beach Florida
United States Northwestern Medicine Cancer Center Kishwaukee DeKalb Illinois
United States Wayne State University/Karmanos Cancer Institute Detroit Michigan
United States Mayo Clinic Health System-Eau Claire Clinic Eau Claire Wisconsin
United States Mercy Cancer Center-Elyria Elyria Ohio
United States Inova Fair Oaks Hospital Fairfax Virginia
United States Inova Schar Cancer Institute Fairfax Virginia
United States Weisberg Cancer Treatment Center Farmington Hills Michigan
United States McLaren Cancer Institute-Flint Flint Michigan
United States Unity Hospital Fridley Minnesota
United States Northwestern Medicine Cancer Center Delnor Geneva Illinois
United States Memorial Sloan Kettering Westchester Harrison New York
United States M D Anderson Cancer Center Houston Texas
United States MD Anderson West Houston Houston Texas
United States Thompson Cancer Survival Center Knoxville Tennessee
United States Thompson Cancer Survival Center - West Knoxville Tennessee
United States Thompson Proton Center Knoxville Tennessee
United States Karmanos Cancer Institute at McLaren Greater Lansing Lansing Michigan
United States McLaren Cancer Institute-Lapeer Region Lapeer Michigan
United States MD Anderson League City League City Texas
United States Inova Loudoun Hospital Leesburg Virginia
United States Mayo Clinic Health Systems-Mankato Mankato Minnesota
United States Minnesota Oncology Hematology PA-Maplewood Maplewood Minnesota
United States Thompson Oncology Group-Maryville Maryville Tennessee
United States UH Seidman Cancer Center at Landerbrook Health Center Mayfield Heights Ohio
United States UH Seidman Cancer Center at Lake Health Mentor Campus Mentor Ohio
United States Miami Cancer Institute Miami Florida
United States University of Miami Miller School of Medicine-Sylvester Cancer Center Miami Florida
United States UH Seidman Cancer Center at Southwest General Hospital Middleburg Heights Ohio
United States Memorial Sloan Kettering Monmouth Middletown New Jersey
United States Hennepin County Medical Center Minneapolis Minnesota
United States Memorial Sloan Kettering Bergen Montvale New Jersey
United States Memorial Sloan Kettering Cancer Center New York New York
United States New York Proton Center New York New York
United States Mayo Clinic Radiation Therapy-Northfield Northfield Minnesota
United States Thompson Oncology Group-Oak Ridge Oak Ridge Tennessee
United States University of Oklahoma Health Sciences Center Oklahoma City Oklahoma
United States Orlando Health Cancer Institute Orlando Florida
United States McLaren Cancer Institute-Owosso Owosso Michigan
United States University Hospitals Parma Medical Center Parma Ohio
United States University of Pennsylvania/Abramson Cancer Center Philadelphia Pennsylvania
United States Mayo Clinic Hospital in Arizona Phoenix Arizona
United States University Hospitals Portage Medical Center Ravenna Ohio
United States Mayo Clinic in Rochester Rochester Minnesota
United States William Beaumont Hospital-Royal Oak Royal Oak Michigan
United States Siteman Cancer Center at Christian Hospital Saint Louis Missouri
United States Siteman Cancer Center-South County Saint Louis Missouri
United States Washington University School of Medicine Saint Louis Missouri
United States Siteman Cancer Center at Saint Peters Hospital Saint Peters Missouri
United States Huntsman Cancer Institute/University of Utah Salt Lake City Utah
United States UH Seidman Cancer Center at Firelands Regional Medical Center Sandusky Ohio
United States Mayo Clinic in Arizona Scottsdale Arizona
United States University of Washington Medical Center - Montlake Seattle Washington
United States Memorial Hospital East Shiloh Illinois
United States MD Anderson in Sugar Land Sugar Land Texas
United States William Beaumont Hospital - Troy Troy Michigan
United States Memorial Sloan Kettering Nassau Uniondale New York
United States University Hospitals Sharon Health Center Wadsworth Ohio
United States Northwestern Medicine Cancer Center Warrenville Warrenville Illinois
United States University of Cincinnati Cancer Center-West Chester West Chester Ohio
United States UH Seidman Cancer Center at Saint John Medical Center Westlake Ohio
United States UHHS-Westlake Medical Center Westlake Ohio

Sponsors (2)

Lead Sponsor Collaborator
NRG Oncology National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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. 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
Primary 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. From baseline up to 8 years
Secondary Pathologic response rate A Chi-square test will be used to compare the pathologic response rates between the treatment arms. At time of surgery
Secondary 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. From the start of chemoradiation to the end of chemoradiation treatment assessed up to 31 days
Secondary 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. From the last date of chemoradiation up to 8 weeks post chemoradiation
Secondary 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. 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
Secondary 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. 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
Secondary 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. 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
Secondary Quality-adjusted life years (QALY) Will be evaluated and compared using EuroQol five-dimensional questionnaire (EQ-5D) only if the primary endpoint is met. Assessed up to 8 years
Secondary 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. Assessed up to 8 years
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