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

December 19, 2018 updated by: University of Florida

A Phase II Trial of Dose Escalated Proton Beam Therapy or Photon Therapy for Resectable and Unresectable Esophageal Cancer

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.

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

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 Type

Interventional

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Florida
      • Jacksonville, Florida, United States, 32206
        • University of Florida Proton Therapy Institute

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Proton
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
Radiation: Proton Beam Therapy
59.4 Gy (RBE) in 1.8 Gy per fraction plus weekly chemotherapy at standard doses
Other Names:
  • Proton Therapy
Drug: Chemotherapy
Concurrent weekly chemotherapy at standard doses
Other Names:
  • Carboplatin
  • Paclitaxel
Active Comparator: Photon
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
Drug: Chemotherapy
Concurrent weekly chemotherapy at standard doses
Other Names:
  • Carboplatin
  • Paclitaxel
Radiation: Photon Radiation Therapy
59.4 Gy (RBE) in 1.8 Gy per fraction plus weekly chemotherapy at standard doses
Other Names:
  • IMRT

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Time Frame: Approximately 12 months after radiation therapy
Participants with a clinically significant reduction of DLCO approximately 12 months after radiation therapy
Approximately 12 months after radiation therapy

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Compare quality of life
Time Frame: 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
Approximately 12 months after radiation therapy
Compare outcomes for local control
Time Frame: 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
Approximately 12 months after radiation therapy
Compare outcomes for progression free survival
Time Frame: 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
Approximately 12 months after radiation therapy
Compare overall survival rates
Time Frame: 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
Approximately 12 months after radiation therapy

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Florida

Investigators

  • Principal Investigator: Michael Rutenberg, MD, PhD, UF Health Proton Therapy Institute

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 30, 2017

Primary Completion (Actual)

December 11, 2018

Study Completion (Actual)

December 11, 2018

Study Registration Dates

First Submitted

July 21, 2017

First Submitted That Met QC Criteria

July 26, 2017

First Posted (Actual)

July 31, 2017

Study Record Updates

Last Update Posted (Actual)

December 21, 2018

Last Update Submitted That Met QC Criteria

December 19, 2018

Last Verified

December 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • UFPTI 1605-ES01

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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