Metformin as a Metabolic Intervention in Oesophageal Adenocarcinomas to Improve Response to Neoadjuvant Chemoradiotherapy
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorAmsterdam UMC, location VUmc
About this trial
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 criteria
Qualifiers
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).
Absolute Neutrophil Count ≥ 1.5 x 10^9/L
Disqualifiers
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.
Trial design
Treatments tested in this trial
- Metformin
Treatment groups
14 Participants
are divided into 1 treatment groupSponsors and collaborators
Amsterdam UMC, location VUmc
Lead sponsor
Cancer Center Amsterdam Research Foundation
Collaborator
Source ClinicalTrials.gov