Comparing Proton Therapy to Photon Radiation Therapy for Esophageal Cancer

Summary

This trial studies how well proton beam radiation therapy compared with intensity modulated photon radiotherapy works in treating patients with stage I-IVA esophageal cancer. Proton beam radiation therapy uses a beam of protons (rather than x-rays) to send radiation inside the body to the tumor without damaging much of the healthy tissue around it. Intensity modulated photon radiotherapy uses high-energy x-rays to deliver radiation directly to the tumor without damaging much of the healthy tissue around it. It is not yet known whether proton beam therapy or intensity modulated photon radiotherapy will work better in treating patients with esophageal cancer.

Conditions

• Clinical Stage I Esophageal Adenocarcinoma AJCC v8
• Clinical Stage I Esophageal Squamous Cell Carcinoma AJCC v8
• Clinical Stage I Gastroesophageal Junction Adenocarcinoma AJCC v8
• Clinical Stage II Esophageal Adenocarcinoma AJCC v8
• Clinical Stage II Esophageal Squamous Cell Carcinoma AJCC v8
• Clinical Stage II Gastroesophageal Junction Adenocarcinoma AJCC v8
• Clinical Stage III Esophageal Adenocarcinoma AJCC v8
• Clinical Stage III Esophageal Squamous Cell Carcinoma AJCC v8
• Clinical Stage III Gastroesophageal Junction Adenocarcinoma AJCC v8
• Clinical Stage IVA Esophageal Adenocarcinoma AJCC v8
• Clinical Stage IVA Esophageal Squamous Cell Carcinoma AJCC v8
• Clinical Stage IVA Gastroesophageal Junction Adenocarcinoma AJCC v8
• Thoracic Esophagus Squamous Cell Carcinoma

Interventions

PROCEDURE

Biospecimen Collection

Undergo blood sample collection

DRUG

Capecitabine

Oral

DRUG

Carboplatin

Given IV

PROCEDURE

Computed Tomography

Undergo CT or PET/CT

DRUG

Docetaxel

IV

PROCEDURE

Esophagectomy

Undergo esophagectomy

DRUG

Fluorouracil

IV

RADIATION

Intensity-Modulated Radiation Therapy

Undergo IMRT

DRUG

Leucovorin Calcium

Oral

DRUG

Oxaliplatin

IV

DRUG

Paclitaxel

Given IV

PROCEDURE

Positron Emission Tomography

Undergo PET/CT

RADIATION

Proton Beam Radiation Therapy

Undergo PBT

OTHER

Quality-of-Life Assessment

Ancillary studies

OTHER

Questionnaire Administration

Ancillary studies

Sponsors & Collaborators

• National Cancer Institute (NCI)

  collaborator NIH

• NRG Oncology

  lead OTHER

Principal Investigators

• Steven H Lin · NRG Oncology

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2019-06-26

Primary Completion

2026-12-21

Completion

2031-12-21

Countries

• United States

Study Locations