NIPH Clinical Trials Search

JRCT ID: jRCTs031180318

Registered date:18/03/2019

A phase II trial of GnP down staging chemotherapy for patients with locally advanced pancreatic cancer(CAP-005)

Basic Information

Recruitment status Complete
Health condition(s) or Problem(s) studiedPancreatic cancer
Date of first enrollment10/05/2016
Target sample size40
Countries of recruitment
Study typeInterventional
Intervention(s)1)Down staging chemotherapy: 3 course of gemcitabine and nab-PTX combination therapy (21days for one course:day1, day8 nab-PTX:125mg/m2/day+GEM:1000mg/m2/day) or total six times administration 2)Surgical resection 3)Adjuvant therapy: 4 course of S-1 monotherapy (42days for one course:day1-28 S-1 80mg/m2)


Primary OutcomeR0 resection rate
Secondary Outcomeresection rate (R0+1), overall survival, disease free survival, pathological chemotherapy effect, adverse events, complication rate, tumor marker, tumor response rate, relative dose intensity, rate of protocol achievement, recurrence type, positive rate of lymph node metastasis

Key inclusion & exclusion criteria

Age minimum>= 20age old
Age maximum<= 80age old
Include criteria1. Invasive ductal carcinoma or invasive intraductal papillary-mucinous carcinoma proved by radiological examination (enhanced CT or MRI) 2. No distant metastasis 3. Borderline or unresectable locally advanced pancreatic cancer tumor abutment of the SMA,CHA,CEA tumor involving PV or SMV diameter of encased PV or SMV are less than 50% of adjacent normal PV or SMV diameter. 4. patients who can tolerate the pancreatic surgery. 5. Age more than 20 or less than 80 6. No history of primary chemotherapy and/or radiation therapy. 7. ECOG performance status 0-1 8. Adequate organ function 9. Without problems for oral medication 10. Written informed consent
Exclude criteria1. History of severe allergic reaction with gemcitabine, nab-paclitaxel or S-1 2. Pregnant females, possibly pregnant females, females wishing to become pregnant, and females feeding babies. 3. Pulmonary fibrosis or interstitial pneumonia 4. History of breast or lung radiation 5. Active infection 6. Patients with pleural effusion 7. Active double cancer 8. Patients with positive for HBs antigen 9. Patients under treatment with phenytoin or walfarin 10. Uncontrolled heart diseases such as angina, myocardial infarction within three months,and cardiac dysfunction 11. Uncontrolled diabetes or hypertension 12. Sever mental disorder 13. Inadequate physical condition, as diagnosed by primary physician

Related Information


Public contact
Name Shigetsugu Takano
Address 1-8-1, Inohana, Cyuoku, Chiba Chiba Japan 260-8670
Telephone +81-43-222-7171
Affiliation Chiba University Hospital
Scientific contact
Name Masayuki Ohtsuka
Address 1-8-1, Inohana, Cyuoku, Chiba Chiba Japan 260-8670
Telephone +81-43-222-7171
Affiliation Chiba University Hospital