RecruitingPhase 2NCT06687876

Metformin as a Metabolic Intervention in Oesophageal Adenocarcinomas to Improve Response to Neoadjuvant Chemoradiotherapy

Metformin as a Metabolic Intervention in Oesophageal Adenocarcinomas to Improve Response to Neoadjuvant Chemoradiotherapy.


Sponsor

Amsterdam UMC, location VUmc

Enrollment

14 participants

Start Date

Mar 9, 2025

Study Type

INTERVENTIONAL

Conditions

Summary

The primary objective of this study is to investigate whether two weeks of metformin treatment can activate the tumour microenvironment in patients with stage II and III oesophageal adenocarcinomas.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study tests whether adding metformin — a medication usually used for diabetes — to standard pre-surgery chemoradiation therapy can improve treatment response in patients with operable esophageal or stomach-esophageal junction adenocarcinoma. **You may be eligible if...** - You have been diagnosed with surgically resectable esophageal or gastroesophageal junction adenocarcinoma (confirmed by biopsy) - You are planning to receive chemoradiation before surgery - You are 18 years or older - Your performance status is ECOG 0–1 (you are generally well enough to be active) - Your blood counts and organ function are within acceptable levels - You are willing to undergo two endoscopies for study purposes **You may NOT be eligible if...** - You already have diabetes and are taking anti-diabetic medication - You are allergic or intolerant to metformin - You have severe kidney disease - You drink alcohol excessively - You take certain medications that interact with metformin - You have had prior treatment (radiation or chemotherapy) to the esophagus - You are pregnant or planning to become pregnant Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGMetformin

Twice a day 500mg of metfomrin orally (1000mg/day) during a 2-week period.


Locations(2)

Amsterdam UMC

Amsterdam, Netherlands

Amsterdam UMC

Amsterdam, Netherlands

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NCT06687876


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