Neoadjuvant chemoradiotherapy with Metformin for locally advanced pancreatic cancer

JRCT ID: jRCTs011180011

Registered date:12/03/2019

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: pancreatic cancer
• Date of first enrollment: 28/07/2015
• Target sample size: 40
• Study type: Interventional

Intervention(s)

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

Outcome(s)

• Primary Outcome: the ratio of histological remnant cancer cells

Secondary Outcome

1) resection rate
2) prognosis (overall survival on 2 years from starting neoadjuvant chemoradio therapy)

Key inclusion & exclusion criteria

• Age minimum: >= 20age old
• Age maximum: <= 80age old
• Gender: Both

Include 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.

Exclude 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.

Related Information

• Primary Sponsor: Taketomi Akinobu
• Secondary ID(s): UMIN000017694