Clinical trial NCT03234842: Dose Escalated Proton Beam Therapy or Photon Therapy for Esophageal Cancer
Official title: A Phase II Trial of Dose Escalated Proton Beam Therapy or Photon Therapy for Resectable and Unresectable Esophageal Cancer
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE2
Conditions: Esophageal Cancer
Keywords: Esophagus
Proton
Radiation
Lead sponsor: University of Florida
Sponsor class: OTHER
First posted: 2017-07-31
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

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 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.

Primary outcomes:
measure: 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
timeFrame: Approximately 12 months after radiation therapy
Secondary outcomes:
measure: Compare quality of life
timeFrame: Approximately 12 months after radiation therapy
measure: Compare outcomes for local control
timeFrame: Approximately 12 months after radiation therapy
measure: Compare outcomes for progression free survival
timeFrame: Approximately 12 months after radiation therapy
measure: Compare overall survival rates
timeFrame: Approximately 12 months after radiation therapy
Other outcomes:
Locations:
city: Jacksonville
country: United States
facility: University of Florida Proton Therapy Institute
state: Florida
Study officials:
affiliation: UF Health Proton Therapy Institute
name: Michael Rutenberg, MD, PhD
role: PRINCIPAL_INVESTIGATOR
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