MEtformin as a MEtabolic iNTervention in Oesophageal adenocarcinomas to improve response to neoadjuvant chemoradiotherapy

Phase 1

• Conditions: Oesophageal adenocarcinoma; Therapeutic area: Diseases [C] - Neoplasms [C04]

• Registration Number: CTIS2024-511626-30-00
• Lead Sponsor: Amsterdam UMC Stichting

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2024-04-19
• Last Update Posted: 21 August 2024

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 14

Inclusion Criteria

Surgical resectable (, Adult patients (age = 18 years)., ECOG performance status 0 or 1 (cf. Appendix A)., Adequate hematological, renal and hepatic functions defined as: oAbsolute Neutrophil Count = 1.5 x 109/L oplatelets = 100 x 109/L ohaemoglobin = 5.6 mmol ototal bilirubin = 1.5 x upper normal limit ocreatinine 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., 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 func-tion precluding major surgery and/or radiation., Serious underlying medical condition which would impair the ability of the patient to re-ceive the planned treatment, including prior allergic reactions to drugs containing Cremo-phor, such as teniposide or cyclosporine., Dementia or altered mental status that would prohibit the understanding and giving of in-formed consent, Patients prescribed metformin or another anti-diabetic drug for any reason., Patients allergic or intolerant to metformin., 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 esophageal 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.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified