NCT01684904

Proton Therapy for Esophageal Cancer

A Phase II Trial of Proton Chemotherapy (PCT) for Resectable Esophageal or Esophagogastric Junction Cancer

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 38 (estimated)
• Sponsor: Loma Linda University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Conditions

• Esophagus Cancer

Interventions

Type	Name	Description
RADIATION	Proton radiation

Timeline

• Start date: 2013-02-20
• Primary completion: 2027-08-01
• Completion: 2032-08-01
• First posted: 2012-09-13
• Last updated: 2025-06-04

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study