Proton Radiation for Esophageal Cancer
Palo Alto (17 mi)Overseen byGary Yang, MD
Age: 18+
Sex: Any
Travel: May be covered
Time Reimbursement: Varies
Trial Phase: N/A
Recruiting
Sponsor: Loma Linda University
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.
Is Proton Radiation a promising treatment for Esophageal Cancer?Yes, Proton Radiation is a promising treatment for Esophageal Cancer. It can target tumors more precisely, reducing damage to healthy tissues and potentially leading to better outcomes and fewer side effects compared to traditional radiation therapies.23567
What safety data exists for proton therapy in esophageal cancer treatment?Proton therapy for esophageal cancer has been studied in various clinical settings, showing promising safety profiles. A multicenter retrospective study in Japan reported low rates of severe toxicities, with only 1% experiencing grade three pericardial effusion and 0.5% grade three pneumonia, and no grade 4 or higher cardiopulmonary toxicities. Another study highlighted the potential of proton therapy to reduce radiation exposure to healthy tissues, although more clinical data is needed to confirm these benefits. A study from 1985 to 1991 showed that proton therapy could achieve complete tumor responses with manageable side effects like esophageal ulcerations, which healed with conservative management. Recent studies suggest proton therapy may result in lower toxicities and better outcomes compared to photon radiotherapy, with ongoing trials aiming to confirm these findings.14568
What data supports the idea that Proton Radiation for Esophageal Cancer is an effective treatment?The available research shows that Proton Radiation, or Proton Beam Therapy, is effective for treating esophageal cancer. Studies have found that it results in excellent survival rates and fewer side effects compared to traditional photon radiation therapy. Proton therapy is especially beneficial because it targets the cancer more precisely, reducing damage to healthy tissues and critical organs. This means patients experience fewer complications and shorter hospital stays. Additionally, a recent study confirmed that proton therapy leads to significantly fewer side effects than another advanced form of radiation therapy called IMRT. Ongoing trials are investigating if proton therapy could become the standard treatment for certain types of esophageal cancer.23567
Do I have to stop taking my current medications for the trial?The trial protocol does not specify if you need to stop taking your current medications. However, since the trial involves chemotherapy and radiation, it's important to discuss your current medications with the trial doctors to ensure there are no interactions.
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
I have had an endoscopy with a tissue sample taken.
I am 18 years old or older.
My cancer is in an early to mid-stage according to AJCC guidelines.
My cancer is a specific type found in the middle, lower esophagus, or where it meets the stomach.
I have had a bronchoscopy to check for fistula in my upper lung area.
My recent blood test shows my bone marrow is working well.
My cancer has spread to nearby lymph nodes but any enlargement is 2cm or less.
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.
My cancer has spread to my windpipe or major airways.
I am not pregnant, nursing, or able to become pregnant and use effective birth control.
I have cancer in the upper part of my esophagus.
I have had radiation therapy for esophageal cancer or in the chest area before.
I have had chemotherapy for esophageal cancer before.
I haven't had cancer (other than non-melanoma skin cancer) in the last 2 years.
I have had radiotherapy where the treated areas overlapped.
Treatment Details
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
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.
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.
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.
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.
[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.
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.