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Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up from surgery to 90-day post-operative
Awards & highlights
Study Summary
This trial will help determine whether or not it is feasible to place a feeding tube in patients with esophageal cancer that makes it difficult for them to eat.
Who is the study for?
Adults with non-cervical esophageal or gastroesophageal junction cancer, stages Ib to III, who are set for induction therapy followed by surgery. Excluded are those with metastatic disease, swallowing difficulties that prevent pill intake, tumors blocking endoscope passage, early-stage patients opting for immediate surgery or endoscopic resection, and anyone refusing a feeding tube.Check my eligibility
What is being tested?
The trial is examining whether placing a feeding tube in the stomach or small bowel during chemo radiation therapy helps maintain calorie intake without causing delays due to complications like dislodgement or infection versus not using a feeding tube at all.See study design
What are the potential side effects?
Potential side effects from the intervention include complications related to the feeding tube such as dislodgement, infection, blockages which might require emergency visits or additional surgeries and could delay cancer treatment.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ from surgery to 90-day post-operative
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from surgery to 90-day post-operative
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Feasibility of the trial
Secondary outcome measures
Any grade adverse event rate
Interruption or dose-reduction of the induction treatment
Nutritional status
+9 moreTrial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: No percutaneous enteral accessExperimental Treatment1 Intervention
No feeding tube placed.
Group II: Percutaneous enteral accessActive Control1 Intervention
Feeding tube, either gastrostomy (G-) tube or gastrojejunostomy (GJ-) tube (placed by Interventional Radiology) or J-tube (surgically placed)
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Who is running the clinical trial?
Mehdi QiabiLead Sponsor
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You have early-stage disease and are planning to have surgery or a minimally invasive procedure to remove the affected area.You have difficulty swallowing pills.It is not possible to insert a medical tool called an endoscope past the tumor.You cannot eat a regular diet with fluids.
Research Study Groups:
This trial has the following groups:- Group 1: Percutaneous enteral access
- Group 2: No percutaneous enteral access
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.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are volunteers being accepted for this scientific experiment presently?
"Per the information on clinicaltrials.gov, this particular study is not currently enrolling patients, as it was last edited in August 4th 2022 and initially posted September 1st of the same year. However, there are 382 other medical trials actively recruiting participants at present."
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