~6 spots leftby Aug 2027

Proton Radiation for Esophageal Cancer

Recruiting in Palo Alto (17 mi)
GY
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.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

GY

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

I have had an endoscopy with a tissue sample taken.
Endoscopic ultrasound
My liver is working well.
See 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
See 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

Treatment Details

Interventions

  • Proton Radiation (Proton Beam Therapy)
Trial OverviewThe 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.
Participant Groups
1Treatment groups
Experimental Treatment
Group I: Proton radiationExperimental Treatment1 Intervention
Proton radiation

Proton Radiation is already approved in Canada, Japan for the following indications:

🇨🇦
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 University

Lead Sponsor

Trials
322
Patients Recruited
267,000+

Findings from Research

Clinical results of proton beam therapy for cancer of the esophagus.Sugahara, S., Tokuuye, K., Okumura, T., et al.[2018]
[The role of proton therapy in esophageal cancer].Créhange, G., Goudjil, F., Krhili, SL., et al.[2022]
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.Choi, JH., Lee, JM., Kim, MS., et al.[2022]
Therapeutic results of proton beam therapy with concurrent chemotherapy for cT1 esophageal cancer and salvage endoscopic therapy for local recurrence.Sato, D., Motegi, A., Kadota, T., et al.[2021]
Proton-beam therapy for locoregionally advanced esophageal cancer showed a high response rate, with 92% of patients (40 out of 51) achieving either a complete or partial response within 4 months of treatment.
The treatment was well-tolerated, with no interruptions due to radiation-induced side effects, and the overall 5-year survival rate was 21.1%, indicating that proton-beam therapy is a promising option for this patient population.
Clinical results of proton-beam therapy for locoregionally advanced esophageal cancer.Mizumoto, M., Sugahara, S., Nakayama, H., et al.[2021]
Clinical Results of Proton Beam Therapy for Esophageal Cancer: Multicenter Retrospective Study in Japan.Ono, T., Wada, H., Ishikawa, H., et al.[2020]
Proton Beam Therapy for Esophageal Cancer.Solidum, JGN., Rojo, RD., Wo, JY., et al.[2022]
Proton beam therapy for patients with esophageal carcinoma.Koyama, S., Tsujii, H., Yokota, H., et al.[2018]
Proton beam therapy and concurrent chemotherapy for esophageal cancer.Lin, SH., Komaki, R., Liao, Z., et al.[2022]

References

Clinical results of proton beam therapy for cancer of the esophagus. [2018]
[The role of proton therapy in esophageal cancer]. [2022]
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]
Therapeutic results of proton beam therapy with concurrent chemotherapy for cT1 esophageal cancer and salvage endoscopic therapy for local recurrence. [2021]
Clinical results of proton-beam therapy for locoregionally advanced esophageal cancer. [2021]
Clinical Results of Proton Beam Therapy for Esophageal Cancer: Multicenter Retrospective Study in Japan. [2020]
Proton Beam Therapy for Esophageal Cancer. [2022]
Proton beam therapy for patients with esophageal carcinoma. [2018]
Proton beam therapy and concurrent chemotherapy for esophageal cancer. [2022]