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JAPANESE
国立保健医療科学院
JRCT ID: jRCT1051190099

Registered date:28/01/2020

Neoadjuvant FOLFIRINOX for borderline or locally advanced pancreatic cancer

Basic Information

Recruitment status Recruiting
Health condition(s) or Problem(s) studiedPancreatic ductal adenocarcinoma
Date of first enrollment19/06/2020
Target sample size25
Countries of recruitmentJapan
Study typeInterventional
Intervention(s)Neoadjuvant FOLFIRINOX followed by curative resection

Outcome(s)

Primary OutcomeR0 resectability
Secondary Outcome- Pancreatic resection - Relative dose intensity - Radiographically response rate - Overall Survival - Distant recurrence-free survival - Disease-free survival - Completion rate for 6 courses of FOLFIRINOX

Key inclusion & exclusion criteria

Age minimum>= 20age old
Age maximum<= 75age old
GenderBoth
Include criteria- Histologically diagnosed pancreatic ducatal adenocarcinoma: including suspected case of adenocarcinoma by a cytology. - Anable to undergo dynamic computed tomography. - Radiologically diagnosed borderline resectable or locally advanced unresectable pancreatic ductal adenocarcinoma according to NCCN guideline 2018. - Age 20 - 75 - ECOG performance status 0 or 1 - No treatment history for pancreatic ductal adenocarcinoma. - No more than grade 1 peripheral sensory and motor neuropathy. - Good functional capacities of main organs within two weekes before enrollment. - Expected survival time more than 3 months. - Feasible for pancreatic resection. - With imformed written consent.
Exclude criteria- Homozygous or double heterozygous fot UGT1A1*28, 6. - Bleeding disorders - Administration of steroid or immunosuppressive drug - Severe complication of main organs - Interstitial pneumonia, pulmonary fibrosis, or severe emphysema - Uncontrollable infectious disease - Uncontrollable diarrhea - Pregnancy - Double cancer with disease-free survival less than 5 years: excluding cured cutaneous basal cell cancer and gastrointestinal cancer with endoscopically curative resection. - Investigator judgement that the patient should not participate for any reason

Related Information

Contact

Public contact
Name Hirochika Toyama
Address 7-5-2 Kusunoki-cho, Chuo-ku, Kobe, Hyogo Hyogo Japan 650-0017
Telephone +81-78-382-6302
E-mail toyama@med.kobe-u.ac.jp
Affiliation Kobe University Hospital
Scientific contact
Name Hirochika Toyama
Address 7-5-2 Kusunoki-cho, Chuo-ku, Kobe, Hyogo Hyogo Japan 650-0017
Telephone +81-78-382-6302
E-mail toyama@med.kobe-u.ac.jp
Affiliation Kobe University Hospital