Dose Escalated Proton Beam Therapy or Photon Therapy for Esophageal Cancer (ES01)

University of Florida

Status and phase: Withdrawn; Phase 2

Conditions: Esophageal Cancer

Treatments: Radiation: Photon Radiation Therapy; Drug: Chemotherapy; Radiation: Proton Beam Therapy

Study type: Interventional

Funder types: Other

Identifiers

NCT03234842

UFPTI 1605-ES01

Details and patient eligibility

About

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.

Full 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.

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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0 participants in 2 patient groups

Proton

Experimental group

Description:

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

Treatment:

Radiation: Proton Beam Therapy

Drug: Chemotherapy

Photon

Active Comparator group

Description:

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

Treatment:

Drug: Chemotherapy

Radiation: Photon Radiation Therapy