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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
Must not have
Patients with T1N0 disease and T4 disease
Medical contraindications to esophagectomy
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 5 years
Awards & highlights
No Placebo-Only Group
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.
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.
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 belowSelect...
I have had an endoscopy with a tissue sample taken.
Select...
I am 18 years old or older.
Select...
My cancer is in an early to mid-stage according to AJCC guidelines.
Select...
My cancer is a specific type found in the middle, lower esophagus, or where it meets the stomach.
Select...
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.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
My cancer is either very small and not spread to lymph nodes or very large.
Select...
I cannot undergo surgery to remove my esophagus due to health reasons.
Select...
My cancer has spread to my windpipe or major airways.
Select...
I am not pregnant, nursing, or able to become pregnant and use effective birth control.
Select...
I have cancer in the upper part of my esophagus.
Select...
I have had radiation therapy for esophageal cancer or in the chest area before.
Select...
I have had chemotherapy for esophageal cancer before.
Select...
I haven't had cancer (other than non-melanoma skin cancer) in the last 2 years.
Select...
I have had radiotherapy where the treated areas overlapped.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 5 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 5 years
Treatment Details
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
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
Find a Location
Who is running the clinical trial?
Loma Linda UniversityLead Sponsor
316 Previous Clinical Trials
266,662 Total Patients Enrolled
Gary Yang, MDPrincipal Investigator - gyang@llu.edu
Loma Linda University
3 Previous Clinical Trials
51 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility 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.I have had an endoscopy with a tissue sample taken.My liver is working well.My cancer has spread to my windpipe or major airways.I am 18 years old or older.I've been evaluated by a surgeon who agrees I can have surgery to remove my cancer after chemotherapy.I have signed the consent form for this study.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.My cancer is in an early to mid-stage according to AJCC guidelines.I can take care of myself and am up and about more than half of my waking hours.I haven't had cancer (other than non-melanoma skin cancer) in the last 2 years.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.I have had radiotherapy where the treated areas overlapped.
Research Study Groups:
This trial has the following groups:- Group 1: Proton radiation
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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