Esophageal Cancer
Conditions
Keywords
Esophagus, Proton, Radiation
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.
Interventions
RADIATIONProton Beam Therapy
59.4 Gy (RBE) in 1.8 Gy per fraction plus weekly chemotherapy at standard doses
RADIATIONPhoton Radiation Therapy
59.4 Gy (RBE) in 1.8 Gy per fraction plus weekly chemotherapy at standard doses
DRUGChemotherapy
Concurrent weekly chemotherapy at standard doses
Sponsors
University of Florida
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 | Approximately 12 months after radiation therapy | Participants with a clinically significant reduction of DLCO approximately 12 months after radiation therapy |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Compare quality of life | 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 | 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 | 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 | 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 |
Countries
United States
Outcome results
None listed