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

This study is currently recruiting participants.
Verified November 2017 by University of Florida
Sponsor:
ClinicalTrials.gov Identifier:
NCT03234842
First Posted: July 31, 2017
Last Update Posted: November 6, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Information provided by (Responsible Party):
University of Florida
  Purpose
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.

Condition Intervention Phase
Esophageal Cancer Radiation: Proton Beam Therapy Radiation: Photon Radiation Therapy Drug: Chemotherapy Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase II Trial of Dose Escalated Proton Beam Therapy or Photon Therapy for Resectable and Unresectable Esophageal Cancer

Resource links provided by NLM:


Further study details as provided by University of Florida:

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 [ Time Frame: Approximately 12 months after radiation therapy ]
    Participants with a clinically significant reduction of DLCO approximately 12 months after radiation therapy


Secondary Outcome Measures:
  • 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

  • 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

  • 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

  • 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


Estimated Enrollment: 90
Actual Study Start Date: October 30, 2017
Estimated Study Completion Date: December 17, 2022
Estimated Primary Completion Date: December 17, 2022 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: 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
Radiation: Photon Radiation Therapy
59.4 Gy (RBE) in 1.8 Gy per fraction plus weekly chemotherapy at standard doses
Other Name: IMRT
Drug: Chemotherapy
Concurrent weekly chemotherapy at standard doses
Other Names:
  • Carboplatin
  • Paclitaxel

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.

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03234842


Contacts
Contact: Intake Coordinator 877-686-6009 intake@floridaproton.org
Contact: Lisa Ward 877-686-6009 lward@floridaproton.org

Locations
United States, Florida
University of Florida Proton Therapy Institute Recruiting
Jacksonville, Florida, United States, 32206
Contact: Intake Coordinator    877-686-6009    intake@floridaproton.org   
Principal Investigator: Michael Rutenberg, MD, PhD         
Sponsors and Collaborators
University of Florida
Investigators
Principal Investigator: Michael Rutenberg, MD, PhD UF Health Proton Therapy Institute
  More Information

Publications:
Venkat P, Shridhar R, Naghavi A, et al. Pathologic Complete Response and Dose Escalation with Preoperative Dose Painting IMRT Chemoradiation in Esophageal Cancer. IJROBP. 2015; 93:S219-220
Wang J, Palmer M, Bilton SD, et al. Comparing Proton Beam to Intensity Modulated Radiation Therapy Planning in Esophageal Cancer. Int J Particle Ther. 2015;1:866-877.

Responsible Party: University of Florida
ClinicalTrials.gov Identifier: NCT03234842     History of Changes
Other Study ID Numbers: UFPTI 1605-ES01
First Submitted: July 21, 2017
First Posted: July 31, 2017
Last Update Posted: November 6, 2017
Last Verified: November 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: No
Pediatric Postmarket Surveillance of a Device Product: No
Product Manufactured in and Exported from the U.S.: No

Keywords provided by University of Florida:
Esophagus
Proton
Radiation

Additional relevant MeSH terms:
Esophageal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Head and Neck Neoplasms
Digestive System Diseases
Esophageal Diseases
Gastrointestinal Diseases