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Proton Beam Therapy

Proton Radiation for Esophageal Cancer

N/A

Recruiting

Led By Gary Yang, MD

Research Sponsored by Loma Linda University

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Endoscopy with biopsy

Age ≥ 18

Timeline

Screening 3 weeks

Treatment Varies

Follow Up the major analysis for reporting the initial results of treatment will be undertaken when each patient has been potentially followed for a minimum of 3 months

Awards & highlights

Study Summary

This trial is a study to see if a new cancer treatment regimen is effective, safe, and feasible.

Who is the study for?

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.Check my eligibility

What is being tested?

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.See study design

What are the potential side effects?

Potential side effects include reactions related to chemotherapy such as nausea, fatigue, blood count changes, kidney function alterations; from radiation like skin irritation, difficulty swallowing; and surgical complications post-treatment.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I have had an endoscopy with a tissue sample taken.

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I am 18 years old or older.

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My cancer is in an early to mid-stage according to AJCC guidelines.

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My cancer is a specific type found in the middle, lower esophagus, or where it meets the stomach.

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I have had a bronchoscopy to check for fistula in my upper lung area.

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My recent blood test shows my bone marrow is working well.

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My cancer has spread to nearby lymph nodes but any enlargement is 2cm or less.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ the major analysis for reporting the initial results of treatment will be undertaken when each patient has been potentially followed for a minimum of 3 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~the major analysis for reporting the initial results of treatment will be undertaken when each patient has been potentially followed for a minimum of 3 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and the major analysis for reporting the initial results of treatment will be undertaken when each patient has been potentially followed for a minimum of 3 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

To assess overall survival of patients treated with proton-chemotherapy (PCT) followed by surgery in patients with resectable primary esophageal or esophagogastric cancer

Secondary outcome measures

Number of participants with adverse events as a measure of safety and tolerability

Trial Design

1Treatment groups

Experimental Treatment

Group I: Proton radiationExperimental Treatment1 Intervention

Proton radiation

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Proton radiation

2011

Completed Phase 2

~20

0 / 7Eligibility criteria met

Find a Location

Who is running the clinical trial?

Loma Linda UniversityLead Sponsor

306 Previous Clinical Trials

260,946 Total Patients Enrolled

Gary Yang, MDPrincipal Investigator - gyang@llu.edu

Loma Linda University

3 Previous Clinical Trials

51 Total Patients Enrolled

Media Library

Proton Radiation (Proton Beam Therapy) Clinical Trial Eligibility Overview. Trial Name: NCT01684904 — N/A

Esophageal Cancer Research Study Groups: Proton radiation

Esophageal Cancer Clinical Trial 2023: Proton Radiation Highlights & Side Effects. Trial Name: NCT01684904 — N/A

Proton Radiation (Proton Beam Therapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT01684904 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is recruitment ongoing for this research initiative?

"Data hosted on clinicaltrials.gov indicates that this medical trial is presently enrolling candidates; the initial posting was made on February 20th 2013 and the most recent edit was done on February 16th 2022."

Answered by AI

What is the current magnitude of participation in this trial?

"Affirmative. Clinicaltrials.gov contains verifiable information confirming that this medical trial is currently seeking candidates, which was initially posted on February 20th 2013 and most recently modified on February 16th 2022. 38 participants are required to be enrolled from a solitary site."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Proton Therapy for Esophageal Cancer

Gary Yang, MD 2013. "Proton Therapy for Esophageal Cancer". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT01684904.

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