Dose Escalated Proton Beam Therapy or Photon Therapy for Esophageal Cancer

Study Overview
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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.

Official Title
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A Phase II Trial of Dose Escalated Proton Beam Therapy or Photon Therapy for Resectable and Unresectable Esophageal Cancer

Conditions
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Esophageal Cancer

Intervention / Treatment
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* Radiation: Proton Beam Therapy
* Radiation: Photon Radiation Therapy
* Drug: Chemotherapy


Participation Criteria
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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. 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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Proton<br>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 | Radiation: Proton Beam Therapy<br>* 59.4 Gy (RBE) in 1.8 Gy per fraction plus weekly chemotherapy at standard doses<br>* Other names: Proton Therapy;Drug: Chemotherapy<br>* Concurrent weekly chemotherapy at standard doses<br>* Other names: Paclitaxel;|
| Active Comparator: Photon<br>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 | Radiation: Photon Radiation Therapy<br>* 59.4 Gy (RBE) in 1.8 Gy per fraction plus weekly chemotherapy at standard doses<br>* Other names: IMRT;Drug: Chemotherapy<br>* Concurrent weekly chemotherapy at standard doses<br>* Other names: Paclitaxel;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Compare the rate of a clinically significant reduction of DLCO (defined as a decrease of ≥ 10% from baseline) between protons and photons after preoperative or definitive chemoradiation | Participants with a clinically significant reduction of DLCO approximately 12 months after radiation therapy | Approximately 12 months after radiation therapy | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Compare quality of life | Participants quality of life results using EORTC Quality of Life Questionnaire - Oesophageal Cancer Module (OES-18) and EORTC QLQ C-30 conjointly approximately 12 months after radiation therapy | Approximately 12 months after radiation therapy | 
| Compare outcomes for local control | Number of participants with local control for proton and photon radiation and concurrent chemotherapy as part of definitive therapy or trimodality therapy approximately 12 months after radiation therapy | Approximately 12 months after radiation therapy | 
| Compare outcomes for progression free survival | Number of participants with progression free survival for proton and photon radiation and concurrent chemotherapy as part of definitive therapy or trimodality therapy approximately 12 months after radiation therapy | Approximately 12 months after radiation therapy | 
| Compare overall survival rates | Number of participants with overall survival rates for proton and photon radiation and concurrent chemotherapy as part of definitive therapy or trimodality therapy approximately 12 months after radiation therapy | Approximately 12 months after radiation therapy | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Esophagus, Proton, Radiation