Proton Therapy for Esophageal Cancer

Part of paid clinical trials in Loma Linda, California.

Sponsor
Loma Linda University
Study ID
NCT01684904
Status
Recruiting
Apply to this trial

Conditions

  • Esophagus Cancer

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Proton radiation — RADIATION

Study Details

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.

Key Dates

Start date
Feb 20, 2013
Status verified
Jun 2026
Primary completion
Aug 31, 2027
Completion
Aug 31, 2032

Study Design

Enrollment
38 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Proton radiation
    Proton radiation

Primary Outcome Measure

To assess overall survival of patients treated with proton-chemotherapy (PCT) followed by surgery in patients with resectable primary esophageal or esophagogastric cancer [ Time Frame: The major analysis for reporting the initial results of treatment will be undertaken when each patient has been potentially followed for a minimum of 3 months ]

Central Contacts

  • Proton Referral Office First call: Referral Office intake personnel
    909-558-4288 or 1 800 PROTONS
  • Gary Yang, MD
    909-558-4000
    [email protected]

Locations (1)

FacilityCityStateZIPSite coordinators
Loma Linda University Medical CenterLoma LindaCalifornia92354
Gary Yang, MD
[email protected]
909-558-4280
Gary Yang, MD (PRINCIPAL_INVESTIGATOR)

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