Comparing Proton Therapy to Photon Radiation Therapy for 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

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• Biospecimen Collection — PROCEDURE
  Undergo blood sample collection
• Capecitabine — DRUG
  Oral
• Carboplatin — DRUG
  Given IV
• Computed Tomography — PROCEDURE
  Undergo CT or PET/CT
• Docetaxel — DRUG
  IV
• Esophagectomy — PROCEDURE
  Undergo esophagectomy
• Fluorouracil — DRUG
  IV
• Intensity-Modulated Radiation Therapy — RADIATION
  Undergo IMRT
• Leucovorin Calcium — DRUG
  Oral
• Oxaliplatin — DRUG
  IV
• Paclitaxel — DRUG
  Given IV
• Positron Emission Tomography — PROCEDURE
  Undergo PET/CT
• Proton Beam Radiation Therapy — RADIATION
  Undergo PBT
• Quality-of-Life Assessment — OTHER
  Ancillary studies
• Questionnaire Administration — OTHER
  Ancillary studies

Study Details

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.

Key Dates

Start date

Jun 26, 2019

Status verified

Apr 2026

Primary completion

Dec 21, 2026

Completion

Dec 21, 2031

Study Design

Enrollment

300 participants (estimated)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: Group I (PBT, concurrent chemotherapy, esophagectomy)
  Patients undergo PBT over 28 fractions 5 days a week for 5.5 weeks. Patients also receive chemotherapy consisting of carboplatin/paclitaxel, or FOLFOX/CAPOX, or docetaxel/5-FU (with capecitabine an acceptable substitute for 5-FU) as determined by the patient and their treating physician while undergoing PBT. Additionally, patients undergo blood sample collection, and PET/CT or CT throughout the study.
• Active Comparator: Group II (IMRT, concurrent chemotherapy, esophagectomy)
  Patients undergo IMRT over 28 fractions 5 days a week for 5.5 weeks. Patients also receive chemotherapy consisting of carboplatin/paclitaxel, or FOLFOX/CAPOX, or docetaxel/5-FU (with capecitabine an acceptable substitute for 5-FU) as determined by the patient and their treating physician while undergoing IMRT. Additionally, patients undergo blood sample collection, and PET/CT or CT throughout the study.

Primary Outcome Measure

Overall survival (OS) [ Time Frame: From the date of randomization to the date of death due to any cause or date of last follow-up for patients without an OS event reported. This analysis occurs after 173 deaths; estimated to occur 4 years after accrual completion ]

Locations (95)

Find similar trials in Phoenix, AZ

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