Dose Escalated Proton Beam Therapy or Photon Therapy for Esophageal Cancer (ES01)
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ClinicalTrials.gov Identifier: NCT03234842 |
Recruitment Status
:
Recruiting
First Posted
: July 31, 2017
Last Update Posted
: November 6, 2017
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Esophageal Cancer | Radiation: Proton Beam Therapy Radiation: Photon Radiation Therapy Drug: Chemotherapy | Phase 2 |
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 (Clinical Trial) |
Estimated Enrollment : | 90 participants |
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 |
Actual Study Start Date : | October 30, 2017 |
Estimated Primary Completion Date : | December 17, 2022 |
Estimated Study Completion Date : | December 17, 2022 |

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
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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:
|
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:
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- 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
- 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

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Ages Eligible for Study: | 18 Years and older (Adult, Senior) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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.

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
Contact: Intake Coordinator | 877-686-6009 | intake@floridaproton.org | |
Contact: Lisa Ward | 877-686-6009 | lward@floridaproton.org |
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 |
Principal Investigator: | Michael Rutenberg, MD, PhD | UF Health Proton Therapy Institute |
Publications:
Responsible Party: | University of Florida |
ClinicalTrials.gov Identifier: | NCT03234842 History of Changes |
Other Study ID Numbers: |
UFPTI 1605-ES01 |
First Posted: | July 31, 2017 Key Record Dates |
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 |