Esophageal Cancer Clinical Trial

Dose Escalated Proton Beam Therapy or Photon Therapy for Esophageal Cancer

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.

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Full 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.

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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.

Study is for people with:

Esophageal Cancer

Phase:

Phase 2

Study ID:

NCT03234842

Recruitment Status:

Withdrawn

Sponsor:

University of Florida

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There is 1 Location for this study

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University of Florida Proton Therapy Institute
Jacksonville Florida, 32206, United States

How clear is this clinincal trial information?

Study is for people with:

Esophageal Cancer

Phase:

Phase 2

Study ID:

NCT03234842

Recruitment Status:

Withdrawn

Sponsor:


University of Florida

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