Dose Escalated Proton Beam Therapy or Photon Therapy for Esophageal Cancer
NCT ID: NCT03234842
Last Updated: 2018-12-21
Study Results
Results pending
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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Recruitment Status
WITHDRAWN
Clinical Phase
PHASE2
Study Classification
INTERVENTIONAL
Study Start Date
2017-10-30
Study Completion Date
2018-12-11
Brief Summary
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This study will evaluate if proton beam therapy as part of chemoradiation results in a decrease in diffusion lung capacity of carbon monoxide (DLCO) compared to photon radiation therapy for esophageal carcinoma. A secondary objective is to determine effects on cardiac function, quality of life, and compare acute and late toxicities.
Detailed Description
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Radiation Modality: Proton radiotherapy will be offered to all patients that meet trial eligibility. If patients decline proton radiotherapy or are otherwise unable to receive proton therapy they will be included in x-ray cohort (group 2).
Chemotherapy will be delivered at the discretion of the treating Medical Oncologist. Weekly carboplatin and paclitaxel at standard doses is preferred. It is recommended that the weekly chemotherapy regimen be continued throughout the course of radiotherapy. Chemotherapy should begin within 48 hours of beginning radiotherapy.
Chemotherapy will be delivered at the discretion of the treating Medical Oncologist. Weekly carboplatin and paclitaxel at standard doses is preferred. It is recommended that the weekly chemotherapy regimen be continued throughout the course of radiotherapy. Chemotherapy should begin within 48 hours of beginning radiotherapy.
Conditions
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Esophageal Cancer
Keywords
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Esophagus
Proton
Radiation
Study Design
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Allocation Method
NON_RANDOMIZED
Intervention Model
PARALLEL
Primary Study Purpose
TREATMENT
Blinding Strategy
NONE
Study Groups
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Proton
Proton beam therapy of 59.4 Gy in 1.8 Gy fractions (50.4 Gy if unable to meet cardiac/lung- organs at risk (OAR) constraints) plus concurrent standard chemotherapy
Group Type
EXPERIMENTAL
Proton Beam Therapy
Intervention Type
RADIATION
59.4 Gy (RBE) in 1.8 Gy per fraction plus weekly chemotherapy at standard doses
Chemotherapy
Intervention Type
DRUG
Concurrent weekly chemotherapy at standard doses
Photon
Photon Radiation therapy of 59.4 Gy in 1.8Gy fractions ( 50.4 Gy if unable to meet cardiac/lung- organs at risk (OAR) constraints) plus concurrent standard chemotherapy
Group Type
ACTIVE_COMPARATOR
Photon Radiation Therapy
Intervention Type
RADIATION
59.4 Gy (RBE) in 1.8 Gy per fraction plus weekly chemotherapy at standard doses
Chemotherapy
Intervention Type
DRUG
Concurrent weekly chemotherapy at standard doses
Interventions
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Proton Beam Therapy
59.4 Gy (RBE) in 1.8 Gy per fraction plus weekly chemotherapy at standard doses
Intervention Type
RADIATION
Photon Radiation Therapy
59.4 Gy (RBE) in 1.8 Gy per fraction plus weekly chemotherapy at standard doses
Intervention Type
RADIATION
Chemotherapy
Concurrent weekly chemotherapy at standard doses
Intervention Type
DRUG
Other Intervention Names
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Proton Therapy
IMRT
Carboplatin
Paclitaxel
Eligibility Criteria
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Inclusion Criteria
* Patient must be at least 18 years at the time of consent.
* Pathologically confirmed esophageal adenocarcinoma or squamous cell. carcinoma of the thoracic esophagus or esophagogastric junction.
* Patient's preliminary cancer stage, according to the AJCC 7th edition staging, must be cT1b-T4, N0-N3.
* Pathologically confirmed esophageal adenocarcinoma or squamous cell. carcinoma of the thoracic esophagus or esophagogastric junction.
* Patient's preliminary cancer stage, according to the AJCC 7th edition staging, must be cT1b-T4, N0-N3.
Exclusion Criteria
* Patients with cervical esophageal carcinoma.
* Prior radiotherapy with fields overlapping the current esophageal cancer.
* Patients with cT1a disease.
* Patients with evidence of tracheoesophageal fistula must undergo bronchoscopy to exclude fistula.
* Patients with distant metastatic disease.
* Prior radiotherapy with fields overlapping the current esophageal cancer.
* Patients with cT1a disease.
* Patients with evidence of tracheoesophageal fistula must undergo bronchoscopy to exclude fistula.
* Patients with distant metastatic disease.
Minimum Eligible Age
18 Years
Eligible Sex
ALL
Accepts Healthy Volunteers
No
Sponsors
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University of Florida
OTHER
Sponsor Role
lead
Responsible Party
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Responsibility Role
SPONSOR
Principal Investigators
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Michael Rutenberg, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
UF Health Proton Therapy Institute
Locations
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University of Florida Proton Therapy Institute
Jacksonville, Florida, United States
Site Status
Countries
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United States
References
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Other Identifiers
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UFPTI 1605-ES01
Identifier Type: -
Identifier Source: org_study_id