A double-blind randomized phase II study of AHCC for patients with resectable / borderline resectable pancreatic cancer
- Conditions
- Pancreatic cancer
- Registration Number
- JPRN-jRCTs051200029
- Lead Sponsor
- Satoi Sohei
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 230
1.Histologically proven invasive ductal carcinoma of the pancreas (adenocarcinoma, adenosquamous carcinoma), resectable (R) or borderline resectable (BR-A, BR-V) in General Rules for the Study of Pancreatic Cancer (the 7th Edition)
2.Patients who undergo preoperative chemotherapy
3.Eastern Cooperative Oncology Group performance status of 0 or 1
4.Adequate bone marrow, liver, and kidney function in measurements taken within 14 days before registration (leucocyte count >= 3000 cells per mm3 and <= 12 000 cells per mm3; leucocyte count >= 2000 cells per mm3; haemoglobin concentration >= 8.0 g/dL; platelet count >= 100 000 cells per mm3; total bilirubin <= 2.0 mg/dL (3.0 mg/dL for patients with biliary stent); aspartate aminotransferase (AST) and alanine aminotransferase (ALT) concentrations <= 150 IU/L; serum creatinine concentrations <= 1.2 mg/dL; creatinine clearance >= 50mL/min
5.Possibility of adequate oral intake
6.Provide written informed consent
7.Be aged 20 years or older with sufficient judgement
1.Unresectable pancreatic cancer (UP-M) due to distant metastasis (eg, distant lymph nodes, liver, peritoneal dissemination, lung, pleural dissemination, brain, and bone) in General Rules for the Study of Pancreatic Cancer (the 7th Edition)
2.Local advanced unresectable pancreatic cancer (UP-LA) in General Rules for the Study of Pancreatic Cancer (the 7th Edition)
3.Already treated for pancreatic cancer before registration with such as chemotherapy, radiation, or immune therapy
4.Patients who undergo surgery without preoperative chemotherapy (up-front surgery)
5.Serious drug allergy to S-1, gemcitabine, nab-paclitaxel, paclitaxel, oxaliplatin, irinotecan, leucovorin, or fluorouracil
6.Active infectious disease (eg, pyrexia of 38 degrees of body temperature or higher)
7.Had other serious complications (eg, heart failure, kidney failure, pulmonary failure, or liver failure, uncontrollable diabetes)
8.Gastrointestinal bleeding which needs repeated blood transfusion
9.Inadequately controlled watery diarrhea
10.Complicating psychiatric disorder or psychological symptoms
11.Active multiple primary cancers
12.Pregnant, breastfeeding, childbearing potential, or willing to bear children
13.Receiving flucytosine, phenytoin, or warfarin potassium
14.Unable to provide written informed consent
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method