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

JRCT ID: jRCTs031180318

Registered date:18/03/2019

Basic Information

• Recruitment status: Complete
• Health condition(s) or Problem(s) studied: Pancreatic cancer
• Date of first enrollment: 10/05/2016
• Target sample size: 40
• Study type: Interventional

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)

Outcome(s)

• Primary Outcome: R0 resection rate
• Secondary Outcome: resection 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
• Gender: Both

Include criteria

1. 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 criteria

1. 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

• Primary Sponsor: Ohtsuka Masayuki
• Source(s) of Monetary Support: Kojin-kai
• Secondary ID(s): UMIN000022241