Dose Escalated Proton Beam Therapy or Photon Therapy for Esophageal Cancer

Phase 2

Withdrawn

• Conditions: Esophageal Cancer
• Interventions: Radiation: Proton Beam Therapy; Radiation: Photon Radiation Therapy; Drug: Chemotherapy

• Registration Number: NCT03234842
• Lead Sponsor: University of Florida

Brief Summary

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

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 Timeline

• Study First Submitted: 2017-07-21
• Study First Submitted QC: 2017-07-26
• Study First Posted: 2017-07-31
• Study Start: 2017-10-30
• Status Verified: 2018-12
• Primary Completion: 2018-12-11
• Study Completion: 2018-12-11
• Last Update Submitted: 2018-12-19
• Last Update Posted: 2018-12-21

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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.

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Proton	Proton Beam Therapy	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
Proton	Chemotherapy	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
Photon	Photon Radiation Therapy	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
Photon	Chemotherapy	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

Primary Outcome Measures

Name	Time	Method
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	Approximately 12 months after radiation therapy	Participants with a clinically significant reduction of DLCO approximately 12 months after radiation therapy

Secondary Outcome Measures

Name	Time	Method
Compare quality of life	Approximately 12 months after radiation therapy	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
Compare outcomes for local control	Approximately 12 months after radiation therapy	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
Compare outcomes for progression free survival	Approximately 12 months after radiation therapy	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
Compare overall survival rates	Approximately 12 months after radiation therapy	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

Trial Locations

Locations (1)

University of Florida Proton Therapy Institute; 🇺🇸 Jacksonville, Florida, United States