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New treatment option for Oesophageal Adenocarcinoma
Official title Metformin as a Metabolic Intervention in Oesophageal Adenocarcinomas to Improve Response to Neoadjuvant Chemoradiotherapy
ClinicalTrials.gov ID: NCT06687876
What this study is testing
What is Metformin?
Metformin is an investigational medicine, given as a twice-daily pill taken by mouth, being studied as a potential treatment for oesophageal adenocarcinoma.
Also referred to as Glucient.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Surgical resectable (\<T4b, N0 or N+, M0), and histologically proven adenocarcinoma of the oesophagus or gastro-oesophageal junction planning to...
- Adult patients (age ≥ 18 years).
- ECOG performance status 0 or 1 (cf. Appendix A).
- Adequate hematological, renal and hepatic functions defined as:
- Absolute Neutrophil Count ≥ 1.5 x 10\^9/L
You likely can't join if
- Patients diagnosed with diabetes mellitus type 1 or 2 receiving anti-diabetic drugs.
- Patients prescribed metformin or another anti-diabetic drug for any reason.
- Patients allergic or intolerant to metformin.
- Excessive alcohol consumption.
- Use of OCT1/OCT2 inhibitors (e.g. verapamil, cimetidine, dolutegravir, isavuonazol, trimethoprim, vandetanib, crizotinib and Olaparib).
- Use of OCT1/OCT2 inducers (e.g. rifampicine).
See the full eligibility criteria
- Surgical resectable (\<T4b, N0 or N+, M0), and histologically proven adenocarcinoma of the oesophagus or gastro-oesophageal junction planning to undergo neoadjuvant chemoradiotherapy.
- Adult patients (age ≥ 18 years).
- ECOG performance status 0 or 1 (cf. Appendix A).
- Adequate hematological, renal and hepatic functions defined as:
- Absolute Neutrophil Count ≥ 1.5 x 10\^9/L
- Platelets ≥ 100 x 10\^9/L
- Hemoglobin ≥ 5.6 mmol
- Total bilirubin ≤ 1.5 x upper normal limit
- Creatinine clearance (Cockroft) \> 30 ml/min
- Patients must be willing to undergo two endoscopies for investigational purposes.
- Written, voluntary informed consent.
- Patients must be accessible to follow up and management in the treatment center.
- Patients diagnosed with diabetes mellitus type 1 or 2 receiving anti-diabetic drugs.
- Patients prescribed metformin or another anti-diabetic drug for any reason.
- Patients allergic or intolerant to metformin.
- Excessive alcohol consumption.
- Use of OCT1/OCT2 inhibitors (e.g. verapamil, cimetidine, dolutegravir, isavuonazol, trimethoprim, vandetanib, crizotinib and Olaparib).
- Use of OCT1/OCT2 inducers (e.g. rifampicine).
- Use of immunosuppressive medication (corticosteroids, cyclosporine, tacrolimus, sirolimus, everolimus, cyclophosphamide).
- Previous systemic therapy or radiotherapy on the oesophagus.
- Severe renal impairment (CLcr ≤ 30 ml/min).
- Past (within 5 years) or current history of malignancy other than entry diagnosis interfering with prognosis of oesophageal cancer.
- Previous systemic therapy for other forms of cancer within the last six months.
- Patients with prior allogeneic stem cell or solid organ transplantation
- Pregnancy (positive serum pregnancy test), planning to become pregnant, and lactation.
- Clinically significant cardiovascular disease (including myocardial infarction, unstable angina, symptomatic congestive heart failure, serious uncontrolled cardiac arrhythmia) precluding major surgery.
- Pulmonary fibrosis, active, non-infectious pneumonitis and/or severely impaired lung function precluding major surgery and/or radiation.
- Serious underlying medical condition which would impair the ability of the patient to receive the planned treatment, including prior allergic reactions to drugs containing Cremophor, such as teniposide or cyclosporine.
- Dementia or altered mental status that would prohibit the understanding and giving of informed consent.
The study team makes the final eligibility decision.
Where it's taking place
- Amsterdam, Netherlands
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Amsterdam, Netherlands. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.