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Efficacy of neoadjuvant chemoradiotherapy with Metformin for locally advanced pancreatic cancer

Efficacy of neoadjuvant chemoradiotherapy with Metformin for locally advanced pancreatic cancer - PK-NACRT-Gmet

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000017694
Enrollment
40
Registered
2015-05-28
Start date
2015-06-18
Completion date
Unknown
Last updated
2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

pancreatic cancer

Interventions

Duration: 3 months Dose Neoadjuvant chemoradiation: Gemcitabine(150mg/m2/w)+RT(50.4G/28f) Metformin: from 5days before starting neoadjuvant chemoradiation until surgery.(1500mg/3x)

Sponsors

Hokkaido University Graduate School of Medicine Gastroenterological Surgery 1
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1) Certification of pancreatic cancer (histological confirmation is desired). 2) Beyond borderline resectable pancreatic cancer (NCCN guideline 2013 ver.1). 3) No prior anti-tumor therapy for pancreatic cancer. 4) Patient age: over 20 years old, 80 years old or less. 5) Performance status (ECOG) is 0 or 1. 6) Essential organ function is preserved. WBC counts: over 3000/mm3 Neutrophil counts: over 2000/mm3 Platelets counts: over10^4/mm3 Hb: over 9 g/dl TBil: below 3.0 mg/dl AST/ALT: 5 times less than the upper limit of normal Serum creatinine: below 1.3mg/dl (male) 1.2mg/dl (female) 7) Patients with type 2 diabetes 8) Written consent has been obtained from the patient himself.

Exclusion criteria

Exclusion criteria: 1) Pulmonary fibrosis or interstitial pneumonia 2) severe infectious disease 3) Patients with uncontrolled heart failure , angina, arrhythmias, and myocardial infarction within 6 months after the onset. 4) uncontrolled diabetes 5) Patients with active infection 6) Patients with pregnant women, the possibility or intention of lactating and pregnant. 7)severe drug allergy 8)peptic ulcer and bleeding 9)obvious neurological disorder or mental disorder 10)active double cancer 11)Patients who are already administered metformin 12)other severe complications 13)The patients who are judged inadequate to the present study by Principal investigator or researcher.

Design outcomes

Primary

MeasureTime frame
the ratio of histological remnant cancer cells

Countries

Japan

Contacts

Public ContactTatsuhiko Kakisaka

Hokkaido University Hospital Gastroenterological Surgery 1

kakisaka@pop.med.hokudai.ac.jp011-706-5927

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026