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.
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.
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
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There are 81 Locations for this study
Phoenix Arizona, 85054, United States More Info
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Scottsdale Arizona, 85259, United States More Info
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Coral Gables Florida, 33146, United States More Info
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Deerfield Beach Florida, 33442, United States More Info
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Miami Florida, 33136, United States More Info
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Miami Florida, 33176, United States More Info
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Orlando Florida, 32806, United States
Atlanta Georgia, 30308, United States More Info
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Atlanta Georgia, 30308, United States More Info
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Atlanta Georgia, 30322, United States More Info
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Atlanta Georgia, 30342, United States More Info
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Alton Illinois, 62002, United States More Info
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DeKalb Illinois, 60115, United States More Info
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Geneva Illinois, 60134, United States More Info
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Shiloh Illinois, 62269, United States More Info
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Warrenville Illinois, 60555, United States More Info
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Baltimore Maryland, 21201, United States More Info
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Baltimore Maryland, 21201, United States More Info
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Bel Air Maryland, 21014, United States More Info
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Boston Massachusetts, 02114, United States More Info
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Bay City Michigan, 48706, United States More Info
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Dearborn Michigan, 48124, United States More Info
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Detroit Michigan, 48201, United States More Info
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Farmington Hills Michigan, 48334, United States More Info
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Flint Michigan, 48532, United States More Info
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Lansing Michigan, 48910, United States More Info
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Lapeer Michigan, 48446, United States More Info
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Owosso Michigan, 48867, United States More Info
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Royal Oak Michigan, 48073, United States More Info
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Troy Michigan, 48085, United States More Info
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Albert Lea Minnesota, 56007, United States
Fridley Minnesota, 55432, United States More Info
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Mankato Minnesota, 56001, United States
Maplewood Minnesota, 55109, United States More Info
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Minneapolis Minnesota, 55415, United States More Info
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Northfield Minnesota, 55057, United States More Info
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Rochester Minnesota, 55905, United States More Info
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Creve Coeur Missouri, 63141, United States More Info
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Saint Louis Missouri, 63110, United States More Info
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Saint Louis Missouri, 63129, United States More Info
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Saint Louis Missouri, 63136, United States More Info
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Saint Peters Missouri, 63376, United States More Info
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Basking Ridge New Jersey, 07920, United States More Info
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Middletown New Jersey, 07748, United States More Info
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Montvale New Jersey, 07645, United States More Info
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Commack New York, 11725, United States More Info
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Harrison New York, 10604, United States More Info
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New York New York, 10035, United States More Info
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New York New York, 10065, United States More Info
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Uniondale New York, 11553, United States More Info
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Beachwood Ohio, 44122, United States More Info
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Chardon Ohio, 44024, United States More Info
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Cincinnati Ohio, 45219, United States More Info
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Cleveland Ohio, 44106, United States More Info
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Elyria Ohio, 44035, United States
Mayfield Heights Ohio, 44124, United States More Info
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Mentor Ohio, 44060, United States More Info
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Middleburg Heights Ohio, 44130, United States More Info
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Parma Ohio, 44129, United States More Info
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Ravenna Ohio, 44266, United States More Info
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Sandusky Ohio, 44870, United States More Info
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Wadsworth Ohio, 44281, United States More Info
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West Chester Ohio, 45069, United States More Info
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Westlake Ohio, 44145, United States More Info
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Westlake Ohio, 44145, United States More Info
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Oklahoma City Oklahoma, 73104, United States More Info
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Philadelphia Pennsylvania, 19104, United States More Info
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Knoxville Tennessee, 37909, United States More Info
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Knoxville Tennessee, 37916, United States More Info
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Knoxville Tennessee, 37932, United States More Info
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Maryville Tennessee, 37804, United States More Info
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Oak Ridge Tennessee, 37830, United States More Info
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Conroe Texas, 77384, United States More Info
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Houston Texas, 77030, United States More Info
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Houston Texas, 77079, United States More Info
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League City Texas, 77573, United States More Info
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Sugar Land Texas, 77478, United States More Info
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Salt Lake City Utah, 84112, United States More Info
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Alexandria Virginia, 22304, United States More Info
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Fairfax Virginia, 22031, United States More Info
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Fairfax Virginia, 22033, United States More Info
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Leesburg Virginia, 20176, United States More Info
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Seattle Washington, 98195, United States
Eau Claire Wisconsin, 54701, United States More Info
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