Protocol Summary

Protocol No.: OCR15673

Sponsor Protocol No.: ES01

Study Title
UFPTI 1605-ES01: A Phase II Trial of Dose Escalated Proton Beam Therapy or Photon Therapy for Resectable and Unresectable Esophageal Cancer

Principal Investigator(s)
Rutenberg, Michael

Objective
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.

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.

Phase: Phase II (Cancer Control)

Age Group: Adult

Scope: Local

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

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

Detailed Eligibility
INCLUSION CRITERIA:
1. Patient must be at least 18 years at the time of consent.
2. Pathologically confirmed esophageal adenocarcinoma or squamous cell. carcinoma of the thoracic esophagus or esophagogastric junction.
3. Patient's preliminary cancer stage, according to the AJCC 7th edition staging, must be cT1b-T4, N0-N3.

EXCLUSION CRITERIA:
1. Patients with cervical esophageal carcinoma.
2. Prior radiotherapy with fields overlapping the current esophageal cancer.
3. Patients with cT1a disease.
4. Patients with evidence of tracheoesophageal fistula must undergo bronchoscopy to exclude fistula.
5. Patients with distant metastatic disease.

Applicable Disease Sites
Gastrointestinal Cancer

Participating Institutions
UF Gainesville : Robin Toton
UF Jacksonville : Robin Toton

Contact
Robin Toton, RN
Phone: +1 904-588-1460

Email: rtoton@floridaproton.org

More Information:
View study listing on ClinicialTrials.gov
http://www.clinicaltrials.gov/ct2/show/
NCT03234842