RecruitingNot ApplicableNCT01684904

Proton Therapy for Esophageal Cancer

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


Sponsor

Loma Linda University

Enrollment

38 participants

Start Date

Feb 20, 2013

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study tests whether proton radiation therapy (a precise form of radiation) combined with chemotherapy is an effective treatment for esophageal cancer (cancer of the food pipe) before surgery. **You may be eligible if...** - You have been confirmed to have esophageal cancer (either squamous cell or adenocarcinoma) in the middle or lower part of the esophagus - Your cancer has not spread to distant parts of the body (specific stages only) - You are 18 or older and in reasonably good health - Your blood counts, kidney, and liver function are within acceptable levels - A surgeon has confirmed that surgery to remove the cancer is possible after treatment **You may NOT be eligible if...** - Your cancer is at the very top of the esophagus (cervical) - You have had prior radiation to your chest or previous chemotherapy for this cancer - You have had another cancer in the past 2 years (skin cancers are generally okay) - You are pregnant or breastfeeding, or unwilling to use contraception - You have a severe allergy to paclitaxel or carboplatin (the chemotherapy drugs used) - You have serious medical conditions that would make esophageal surgery unsafe Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

RADIATIONProton radiation

Locations(1)

Loma Linda University Medical Center

Loma Linda, California, United States

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NCT01684904


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