AI Cure is a research tool showing open data. Not medical advice. Discuss with your doctor. Terms

โ† Trials
๐Ÿงช

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

RecruitingPhase 2Ages 18 Years - anyAllAmsterdam UMC, location VUmc
๐Ÿ’ฌ

In plain words

What the trial is, and whether it could suit you

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.

Sign in to get the eligibility rules as simple questions to take to your doctor.

๐Ÿ“‹ Eligibility rules (as published)
Inclusion 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 โ‰ฅ 18 years). * ECOG performance status 0 or 1 (cf. Appendix A). * Adequate hematological, renal and hepatic functions defined as: * Absolute Neutrophil Count โ‰ฅ 1.5 x 10\^9/L * Platelets โ‰ฅ 100 x 10\^9/L * Hemoglobin โ‰ฅ 5.6 mmol * Total bilirubin โ‰ค 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. Exclusion Criteria: * 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 โ‰ค 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.
๐Ÿ’Š

What it tests

  • Metformin
๐Ÿ“

Where

2 sites
Amsterdam UMC
Amsterdam, Netherlands
Amsterdam UMC
Amsterdam, Netherlands
๐Ÿค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ€” always decide together with your own doctor.
๐Ÿ›ก๏ธ

AI Cure shows public evidence (Open Targets, ClinicalTrials.gov, PubMed, openFDA, DepMap, AlphaFold) with its source, and AI summaries that cite it โ€” not medical advice and not a cure. Treatment decisions belong with your doctor. Research ideas are shared only with approved researchers and labs, who can test them. In an emergency call your local emergency number (112 in India and Europe, 911 in the US). AI Cure Terms of Use ยท Privacy