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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 randomization to 90-day post-operative
Awards & highlights
No Placebo-Only Group
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.
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.
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 randomization to 90-day post-operative
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from randomization to 90-day post-operative
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Feasibility of the trial
Secondary study objectives
Nutritional status
Quality of life using the EuroQOL 5 Dimensions 3 Levels (EQ-5D-3L) questionnaire
Quality of life using the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Oesophago-gastric 25 (EORTC QLQ-OG25) questionnaire
+3 moreAwards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial 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
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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.
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