About this trial
The goal of this phase II study is to investigate the feasibility, toxicity and efficacy of a regimen incorporating a proven systemic regimen, carboplatin /paclitaxel, with conformal proton modality, followed by definitive surgery. In most combined-modality trials to date, chemotherapy regimens have included cisplatin, usually in conjunction with 5-fluorouracil.
In designing the regimen, the investigators attempt to improve on the standard cisplatin/5-fluorouracil regimen in several ways. First, full-dose paclitaxel is added to the regimen. This agent has activity against advanced esophageal cancer and is also a potent radiosensitizer. Second, the substitution of carboplatin for cisplatin has resulted in reduced toxicity of various combination regimens similar to that used by CROSS trial and allows for easier administration in the outpatient setting.4 Third, for localized esophageal cancer, dose distribution patterns achievable with proton beam could potentially offer important clinical advantages relative to those achievable with x-rays (photons).19 Based on this, the investigators believe that this study should be conducted with the radiation modality that offers the best dosimetry achievable at our institution.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Pathologically confirmed primary squamous cell or adenocarcinoma of the esophagus that involves the mid, distal or esophagogastric junction. The cancer may involve the stomach up to 5 cm.
Endoscopy with biopsy
Absolute neutrophil count (ANC) ≥ 1,500 cells/mm3
Platelets ≥ 100,000 cell/mm3
Disqualifiers
None
Trial design
Single group
Treatments tested in this trial
Proton radiation
Radiation
Treatment groups
Trial outcomes
Primary outcomes
To assess overall survival of patients treated with proton-chemotherapy (PCT) followed by surgery in patients with resectable primary esophageal or esophagogastric cancer
Secondary outcomes
Number of participants with adverse events as a measure of safety and tolerability
Sponsors and contacts
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