Dose Escalated Proton Beam Therapy or Photon Therapy for Esophageal Cancer

University of Florida

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Conditions

Esophageal Cancer

Interventions

Proton Beam TherapyRADIATION

59.4 Gy (RBE) in 1.8 Gy per fraction plus weekly chemotherapy at standard doses

Photon Radiation TherapyRADIATION

59.4 Gy (RBE) in 1.8 Gy per fraction plus weekly chemotherapy at standard doses

ChemotherapyDRUG

Concurrent weekly chemotherapy at standard doses

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

Locations (1)

University of Florida Proton Therapy Institute

Jacksonville, Florida, United States

Outcomes

Primary Outcomes

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