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Dose Escalated Proton Beam Therapy or Photon Therapy for Esophageal Cancer

NCT03234842 · Status: WITHDRAWN · Phase: PHASE2 · Type: INTERVENTIONAL

Last updated 2018-12-21

No results posted yet for this study

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.

Conditions

  • Esophageal Cancer

Interventions

RADIATION

Proton Beam Therapy

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

RADIATION

Photon Radiation Therapy

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

DRUG

Chemotherapy

Concurrent weekly chemotherapy at standard doses

Sponsors & Collaborators

  • University of Florida

    lead OTHER

Principal Investigators

  • Michael Rutenberg, MD, PhD · UF Health Proton Therapy Institute

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-10-30
Primary Completion
2018-12-11
Completion
2018-12-11
FDA Device
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03234842 on ClinicalTrials.gov