Proton Radiation for Esophageal Cancer
Recruiting in Palo Alto (17 mi)
Overseen byGary Yang, MD
Age: 18+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Academic
Recruiting
Sponsor: Loma Linda University
Disqualifiers: Cervical esophageal carcinoma, T1N0, T4, others
No Placebo Group
Approved in 4 Jurisdictions
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.
12345Is 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.
24678How 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.
12349Eligibility 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
I have had an endoscopy with a tissue sample taken.
Endoscopic ultrasound
My liver is working well.
+17 more
Exclusion Criteria
My cancer is either very small and not spread to lymph nodes or very large.
I cannot undergo surgery to remove my esophagus due to health reasons.
Severe, active co-morbidity impacting survival
+8 more
Trial Timeline
Screening
Participants are screened for eligibility to participate in the trial
2-4 weeks
Chemotherapy
Participants receive a regimen of carboplatin and paclitaxel, which includes proton radiation therapy
6-8 weeks
Surgery
Definitive surgery is performed following chemotherapy and radiation
Follow-up
Participants are monitored for safety and effectiveness after treatment
12 weeks
Participant Groups
The study tests a treatment combining carboplatin/paclitaxel chemotherapy with proton radiation therapy followed by surgery. It aims to improve outcomes over traditional chemo regimens by reducing toxicity and using proton beam technology for better dose distribution in localized esophageal cancer.
1Treatment groups
Experimental Treatment
Group I: Proton radiationExperimental Treatment1 Intervention
Proton radiation
Proton Radiation is already approved in United States, European Union, Canada, Japan for the following indications:
🇺🇸 Approved in United States as Proton Therapy for:
- Brain tumors
- Breast cancer
- Esophageal cancer
- Eye cancer
- Gynecological cancers
- Head and neck cancer
- Liver cancer
- Lung cancer
- Lymphoma
- Pancreatic cancer
- Prostate cancer
- Rectal cancer
- Sarcomas
- Spinal cord tumors
🇪🇺 Approved in European Union as Proton Therapy for:
- Similar indications as in the United States, with specific approvals varying by country
🇨🇦 Approved in Canada as Proton Therapy for:
- Similar indications as in the United States, with specific approvals varying by province
🇯🇵 Approved in Japan as Proton Therapy for:
- Similar indications as in the United States, with specific approvals varying by region
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
Loma Linda University Medical CenterLoma Linda, CA
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Who Is Running the Clinical Trial?
Loma Linda UniversityLead Sponsor
References
Clinical results of proton beam therapy for cancer of the esophagus. [2018]To present the results of proton beam therapy for patients with esophageal cancer.
[The role of proton therapy in esophageal cancer]. [2022]Because of the physical properties of proton beam radiation therapy (PT), which allows energy to be deposited at a specific depth with a rapid energy fall-off beyond that depth, PT has several theoretical advantages over photon radiation therapy for esophageal cancer (EC). Protons have the potential to reduce the dose to healthy tissue and to more safely allow treatment of tumors near critical organs, dose escalation, trimodal treatment, and re-irradiation. In recent years, larger multicenter retrospective studies have been published showing excellent survival rates, lower than expected toxicities and even better outcomes with PT than with photon radiotherapy even using IMRT or VMAT techniques. Although PT was associated with reduced toxicities, postoperative complications, and hospital stays compared to photon radiation therapy, these studies all had inherent biases in relation with patient selection for PT. These observations were recently confirmed by a randomized phase II study in locally advanced EC that showed significantly reduced toxicities with protons compared with IMRT. Currently, two randomized phase III trials (NRG-GI006 in the US and PROTECT in Europe) are being conducted to confirm whether protons could become the standard of care in locally advanced and resectable esophageal cancers.
A Comparative Analysis of Photon versus Proton Beam Therapy in Neoadjuvant Concurrent Chemoradiotherapy for Intrathoracic Squamous Cell Carcinoma of the Esophagus at a Single Institute. [2022]Proton beam therapy (PBT), as a neoadjuvant chemoradiotherapy (nCRT) modality, is expected to result in better outcomes than photon-based radiotherapy (RT) for esophageal cancer, particularly adenocarcinoma. This study reports the results of nCRT for locally advanced esophageal squamous cell carcinoma (ESCC) using both modalities.
Therapeutic results of proton beam therapy with concurrent chemotherapy for cT1 esophageal cancer and salvage endoscopic therapy for local recurrence. [2021]Proton beam therapy (PBT) with concurrent chemotherapy is promising for esophageal squamous cell carcinoma (ESCC). The aim of study was to evaluate the outcome of concurrent chemo-proton therapy (CCPT), i.e., PBT with concurrent chemotherapy for cT1 ESCC and the salvage endoscopic therapy for local recurrence.
Clinical results of proton-beam therapy for locoregionally advanced esophageal cancer. [2021]To evaluate the efficacy and safety of proton-beam therapy for locoregionally advanced esophageal cancer.
Clinical Results of Proton Beam Therapy for Esophageal Cancer: Multicenter Retrospective Study in Japan. [2020]There are few reports about the clinical results of proton beam therapy for esophageal cancer in a large population. The purpose of this study was to evaluate the clinical results of proton beam therapy for esophageal cancer in a large population using a multicentered database. Between January 2009 and December 2013, patients newly diagnosed with esophageal cancer and who had received proton beam therapy were retrospectively recruited from a database of four proton beam therapy centers in Japan. Two hundred and two patients (including 90 inoperable patients) fulfilled the inclusion criteria, and 100 patients (49.5%) had stage III/IV cancer (Union for International Cancer Control 8th). The 3-year and 5-year overall survival rate was 66.7% and 56.3%, respectively. The five-year local control rate was 64.4%. There were two patients with grade three pericardial effusion (1%) and a patient with grade three pneumonia (0.5%). No grade 4 or higher cardiopulmonary toxicities were observed (Common Terminology Criteria for Adverse Events version 4.0). This study suggests that proton beam therapy for esophageal cancer was not inferior in efficacy and had lower rates of toxicities in comparison to photon radiotherapy. Therefore, proton beam therapy can serve as an alternate treatment for patients with esophageal cancer.
Proton Beam Therapy for Esophageal Cancer. [2022]Early-stage esophageal cancer is often primarily managed surgically, with the addition of radiotherapy for locally advanced disease. However, current photon-based radiotherapy regimens and surgery results in a high incidence of treatment-related cardiac and pulmonary complications due to the involvement of proximal organs at risk. In addition, the anatomic location of the esophagus raises challenges for radiotherapy due to the anatomical changes associated with diaphragmatic motion, weight loss, tumor changes, and set-up variability. These challenges propelled the interest in proton beam therapy (PBT), which theoretically offers a reduction in the radiation exposure to healthy neighboring tissues with improvements in the therapeutic ratio. Several dosimetric studies support the potential advantages of PBT for esophageal cancer treatment however, translation of these results to improved clinical outcomes remains unclear with limited clinical data, especially in large populations. Studies on the effect on quality of life are likewise lacking. Here, we review the existing and emerging role of PBT for esophageal cancer, including treatment planning, early clinical comparisons of PBT with photon-based techniques, recently concluded and ongoing clinical trials, challenges and toxicities, effects on quality of life, and global inequities in the treatment of esophageal cancer.
Proton beam therapy for patients with esophageal carcinoma. [2018]Fifteen patients with esophageal carcinoma (superficial, six cases; advanced, nine cases) were treated with 250 MeV proton beam irradiation with or without external x-ray irradiation (12 MV linear accelerator) from October, 1985, to May, 1991. Eleven patients were initially treated with x-ray at doses of 16.2-50.4 (mean 42.5) Gy, followed by proton beam at doses of 30.0-52.9 (mean 37.6) Gy. The other four patients were treated with proton beams alone at total doses of 75.0-88.5 (mean 81.4) Gy. The mean total dose for the 15 patients was 80.4 Gy. As a result, the primary tumor lesions of all 15 patients disappeared and complete responses were obtained. Approximately four to five months later, nine of the 15 patients developed esophageal ulcer formations at the circumferences of their primary lesions. The ulcerations were healed, however, by conservative management. There was no evidence of local recurrence throughout the observations on six cases of superficial carcinoma. Among nine advanced carcinoma patients, three relapsed into esophageal carcinoma. Recurrences were observed eight, 16 and 44 months, respectively, after the treatment. Ten of the 15 patients died, but eight died of other diseases. Three of four cases at autopsy did not show any cancer cells in irradiated primary lesions. Four of the 15 patients lived for over five years. The results suggest that a high dose of irradiation delivered by a well-defined proton field could result in improved local control and long-term survival in esophageal carcinoma without undue risk of injury to primary and adjacent organs.
Proton beam therapy and concurrent chemotherapy for esophageal cancer. [2022]Proton beam therapy (PBT) is a promising modality for the management of thoracic malignancies. We report our preliminary experience of treating esophageal cancer patients with concurrent chemotherapy (CChT) and PBT (CChT/PBT) at MD Anderson Cancer Center.