Actively Recruiting
Metformin as a Metabolic Intervention in Oesophageal Adenocarcinomas to Improve Response to Neoadjuvant Chemoradiotherapy
Led by Amsterdam UMC, location VUmc · Updated on 2025-07-10
14
Participants Needed
2
Research Sites
299 weeks
Total Duration
On this page
Sponsors
A
Amsterdam UMC, location VUmc
Lead Sponsor
C
Cancer Center Amsterdam Research Foundation
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Metformin as a Metabolic Intervention in Oesophageal Adenocarcinomas to Improve Response to Neoadjuvant Chemoradiotherapy
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Surgical resectable (<T4b, N0 or N+, M0), histologically confirmed adenocarcinoma of the oesophagus or gastro-oesophageal junction planning neoadjuvant chemoradiotherapy
- Age 18 years or older
- ECOG performance status 0 or 1
- Adequate blood counts: Absolute Neutrophil Count ≥ 1.5 x 10^9/L, Platelets ≥ 100 x 10^9/L, Hemoglobin ≥ 5.6 mmol
- Total bilirubin ≤ 1.5 times upper normal limit
- Creatinine clearance (Cockroft) > 30 ml/min
- Willingness to undergo two endoscopies for research purposes
- Written voluntary informed consent
- Accessible for follow-up and management at the treatment center
You will not qualify if you...
- Diagnosis of diabetes mellitus type 1 or 2 treated with anti-diabetic drugs
- Current use of metformin or other anti-diabetic medications
- Allergy or intolerance to metformin
- Excessive alcohol consumption
- Use of OCT1/OCT2 inhibitors or inducers (specific drugs listed)
- Use of immunosuppressive medications
- Previous systemic therapy or radiotherapy to the oesophagus
- Severe renal impairment (creatinine clearance ≤ 30 ml/min)
- Past or current malignancy within 5 years other than oesophageal cancer affecting prognosis
- Systemic therapy for other cancers within the last six months
- Prior allogeneic stem cell or solid organ transplantation
- Pregnancy, planning pregnancy, or breastfeeding
- Clinically significant cardiovascular disease preventing major surgery
- Pulmonary fibrosis, active non-infectious pneumonitis, or severely impaired lung function preventing surgery or radiation
- Serious medical conditions impairing ability to receive treatment
- Dementia or altered mental status preventing informed consent
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 2 locations
1
Amsterdam UMC
Amsterdam, Netherlands
Not Yet Recruiting
2
Amsterdam UMC
Amsterdam, Netherlands
Actively Recruiting
Research Team
K
Kayla Brugman, Master of Medicine
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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