PDAC-GS/GA-rP2

JRCT ID: jRCTs051180122

Registered date:13/03/2019

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: Pancreatic ductal adenocarcinoma
• Date of first enrollment: 26/04/2016
• Target sample size: 100
• Study type: Interventional

Intervention(s)

Group GS
GEM:1000mg/m2-day1and8
TS-1:80mg/m2-day1-day14
Group GA
GEM:1000mg/m2-day1and8and15
nab-PTX:125mg/m2-day1and8and15

Outcome(s)

• Primary Outcome: Progression free survival time
• Secondary Outcome: Rate of curative resection, Completion rate of protocol therapy, Recurrence type, overall survival time, and safety

Key inclusion & exclusion criteria

• Age minimum: >= 20age old
• Age maximum: Not applicable
• Gender: Both

Include criteria

1. Histologically or cytologically confirmed adenocarcinoma, adenocarcinoma squamous carcinoma of pancreatic cancer.
2. Patients of age =>20
3. Performance Status:0-1(ECOG)
4. Resectable pancreatic cancer
5. Life expectancy more than 6 months.
6. Sufficient organ functions.
(1) neutrophils >=1,500/mm3
(2) platelets >=100,000/mm3
(3) hemoglobin >=9.0g/dl
(4) AST(GOT)/ALT(GPT) <=150IU
(5) total bilirubin <=2.0mg/dl
(or <=3.0mg/dl if biliary drainage were present)
(6) serum creatinine <=1.2mg/dl
(7) creatinine clearance>=60ml/min
7. No treatment before application for this tumor
8. Written informed consent.

Exclude criteria

1) Unresectable pancreatic cancer
2) Lung fibrosis or intestinal pneumonia, and anamnesis or imaging findings.
3) Patients with Brinkman Index =>200
4)Watery diarrhea 5) Severe infection
6) Severe complication
(heart failure, renal failure, hepatic insufficiency,hemorrhagic peptic ulcer, intestines paralysis,ileus or uncontrolled diabetes etc)
7) Massive pleural or abdominal effusion.
8) Metastasis to central nervous system.
9) Active synchronous or metachronous malignancy other than carcinoma in situ.
10) Regular use of frucitocin, fenitoin or warfarin
11) Pregnant or lactation women, or women with known or suspected pregnancy and men who want let to pregnancy
12) Severe mental illness 13) Severe allergy for drugs
14) Patients who are judged inappropriate
for the entry into the study by the investigator.

Related Information

• Primary Sponsor: Kobayashi Syogo
• Secondary ID(s): UMIN000021484