Esophageal Cancer Clinical Trial

Comparing Proton Therapy to Photon Radiation Therapy for Esophageal Cancer

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.

View Full Description

Full 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.

View Eligibility Criteria

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

Study is for people with:

Esophageal Cancer

Phase:

Phase 3

Estimated Enrollment:

300

Study ID:

NCT03801876

Recruitment Status:

Recruiting

Sponsor:

NRG Oncology

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There are 73 Locations for this study

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

How clear is this clinincal trial information?

Study is for people with:

Esophageal Cancer

Phase:

Phase 3

Estimated Enrollment:

300

Study ID:

NCT03801876

Recruitment Status:

Recruiting

Sponsor:


NRG Oncology

How clear is this clinincal trial information?

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