Dose Escalated Proton Beam Therapy or Photon Therapy for Esophageal Cancer



Status:Withdrawn
Conditions:Cancer, Cancer
Therapuetic Areas:Oncology
Healthy:No
Age Range:18 - Any
Updated:12/23/2018
Start Date:October 30, 2017
End Date:December 11, 2018

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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.

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.

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.
We found this trial at
1
site
2015 Jefferson St
Jacksonville, Florida 32206
(904) 588-1800
Principal Investigator: Michael Rutenberg, MD, PhD
Phone: 877-686-6009
University of Florida Proton Therapy Institute When the University of Florida Proton Therapy Institute opened...
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mi
from
Jacksonville, FL
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