Proton Radiation for Esophageal Cancer
Trial Summary
What is the purpose of 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.
Will I have to stop taking my current medications?
The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.
What data supports the effectiveness of the treatment Proton Radiation for Esophageal Cancer?
Research shows that proton therapy for esophageal cancer can lead to excellent survival rates and lower side effects compared to traditional photon radiation. Studies have found that it reduces damage to healthy tissues and has fewer postoperative complications, making it a promising treatment option.12345
Is proton radiation therapy safe for treating esophageal cancer?
Proton radiation therapy for esophageal cancer has shown lower rates of serious side effects compared to traditional photon radiation therapy. Studies have reported some mild to moderate side effects, like esophageal ulcers and rare cases of heart or lung issues, but these were generally manageable and less severe than with other treatments.24678
How is proton radiation treatment different for esophageal cancer?
Proton radiation treatment for esophageal cancer is unique because it allows energy to be deposited at a specific depth, reducing damage to healthy tissue and potentially leading to fewer side effects compared to traditional photon radiation therapy. This makes it safer for treating tumors near critical organs and may result in better outcomes and lower toxicities.12349
Research Team
Gary Yang, MD
Principal Investigator
gyang@llu.edu
Eligibility Criteria
This trial is for adults with confirmed primary squamous cell or adenocarcinoma of the esophagus, involving mid to lower regions or junction. They must have adequate organ function, no prior treatments for esophageal cancer, and be fit for surgery post-therapy. Pregnant women and those unable to use contraception are excluded.Inclusion Criteria
Exclusion Criteria
Trial Timeline
Screening
Participants are screened for eligibility to participate in the trial
Chemotherapy
Participants receive a regimen of carboplatin and paclitaxel, which includes proton radiation therapy
Surgery
Definitive surgery is performed following chemotherapy and radiation
Follow-up
Participants are monitored for safety and effectiveness after treatment
Treatment Details
Interventions
- Proton Radiation (Proton Beam Therapy)
Proton Radiation is already approved in Canada, Japan for the following indications:
- Similar indications as in the United States, with specific approvals varying by province
- Similar indications as in the United States, with specific approvals varying by region
Find a Clinic Near You
Who Is Running the Clinical Trial?
Loma Linda University
Lead Sponsor