Proton Therapy for Esophageal Cancer

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorLoma Linda University

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 volunteers

Qualifiers

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

Design model

Single group

Treatments tested in this trial

  • Proton radiation

    Radiation

Treatment groups

38 Participants
are divided into 1 treatment group
Group A: Proton radiationExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

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

Secondary outcomes

1

Number of participants with adverse events as a measure of safety and tolerability

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

Other outcomes

Sponsors and contacts

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