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

Primary Purpose

Esophageal Cancer

Status
Withdrawn
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Proton Beam Therapy
Photon Radiation Therapy
Chemotherapy
Sponsored by
University of Florida
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Esophageal Cancer focused on measuring Esophagus, Proton, Radiation

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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.

Sites / Locations

  • University of Florida Proton Therapy Institute

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Proton

Photon

Arm 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

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

Outcomes

Primary Outcome Measures

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
Participants with a clinically significant reduction of DLCO approximately 12 months after radiation therapy

Secondary Outcome Measures

Compare quality of life
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
Compare outcomes for local control
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
Compare outcomes for progression free survival
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
Compare overall survival rates
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

Full Information

First Posted
July 21, 2017
Last Updated
December 19, 2018
Sponsor
University of Florida
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1. Study Identification

Unique Protocol Identification Number
NCT03234842
Brief Title
Dose Escalated Proton Beam Therapy or Photon Therapy for Esophageal Cancer
Acronym
ES01
Official Title
A Phase II Trial of Dose Escalated Proton Beam Therapy or Photon Therapy for Resectable and Unresectable Esophageal Cancer
Study Type
Interventional

2. Study Status

Record Verification Date
December 2018
Overall Recruitment Status
Withdrawn
Why Stopped
non-accrual
Study Start Date
October 30, 2017 (Actual)
Primary Completion Date
December 11, 2018 (Actual)
Study Completion Date
December 11, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Florida

4. Oversight

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
Data Monitoring Committee
Yes

5. Study Description

Brief 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Esophageal Cancer
Keywords
Esophagus, Proton, Radiation

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
0 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Proton
Arm Type
Experimental
Arm 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
Arm Title
Photon
Arm Type
Active Comparator
Arm 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
Intervention Type
Radiation
Intervention Name(s)
Proton Beam Therapy
Other Intervention Name(s)
Proton Therapy
Intervention Description
59.4 Gy (RBE) in 1.8 Gy per fraction plus weekly chemotherapy at standard doses
Intervention Type
Radiation
Intervention Name(s)
Photon Radiation Therapy
Other Intervention Name(s)
IMRT
Intervention Description
59.4 Gy (RBE) in 1.8 Gy per fraction plus weekly chemotherapy at standard doses
Intervention Type
Drug
Intervention Name(s)
Chemotherapy
Other Intervention Name(s)
Carboplatin, Paclitaxel
Intervention Description
Concurrent weekly chemotherapy at standard doses
Primary Outcome Measure Information:
Title
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
Description
Participants with a clinically significant reduction of DLCO approximately 12 months after radiation therapy
Time Frame
Approximately 12 months after radiation therapy
Secondary Outcome Measure Information:
Title
Compare quality of life
Description
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
Time Frame
Approximately 12 months after radiation therapy
Title
Compare outcomes for local control
Description
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
Time Frame
Approximately 12 months after radiation therapy
Title
Compare outcomes for progression free survival
Description
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
Time Frame
Approximately 12 months after radiation therapy
Title
Compare overall survival rates
Description
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
Time Frame
Approximately 12 months after radiation therapy

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Michael Rutenberg, MD, PhD
Organizational Affiliation
UF Health Proton Therapy Institute
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Florida Proton Therapy Institute
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32206
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
Undecided
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Dose Escalated Proton Beam Therapy or Photon Therapy for Esophageal Cancer

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