pancreatic ductal adenocarcinoma patients with peritoneal metastasis
Conditions
Interventions
S-1 is administered orally twice daily at a dose of 80mg/m2/d for 14 consecutive days, followed by 7 days of rest. PTX is administered i.v. at a dose of 50mg/m2 and i.p. at 20mg/m2 on days 1 and 8.
N
Sponsors
Study group of pancreatic cancer with peritoneal metastasis
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1.histologically proven pancreatic ductal adenocarcinoma and peritoneal metastasis diagnosed using staging laparoscopy or open laparotomy 2.a chemo-naive patient or a patient within 2 months after introducing the first-line chemotherapy 3.performance status 0 or 1 4.adequate bone marrow, lung, liver amd renal function 5.a patient who can eat by mouth 6.obtained informed consent 7.20 years or more and less than 80 years
Exclusion criteria
Exclusion criteria: 1.Metastasis to distant organ sites such as the liver, lungs, bone and so on except ovary 2.resectable pancreatic ductal adenocarcinoma defined by NCCN guideline with positive peritoneal washing cytology 3.contraindication of S-1 gemcitabine, nab-paclitaxel, and paclitaxel 4. evident infection or inflammation on the entry of the study 5.severe herat disease 6.severe co-morbid diseases 7.highly amount of ascites 8.active intestinal bleeding 9.diarrhea (4 time or more in a day) 10. psychiatric disease 11. other active concomitant malignancies 12. pregnat (probable) or feeding women 13. a patient recognized as inappropriate 14. a petient receiving flucytosine, fenitoin, or warfarin. 15. a patient with allergic reaction to S-1, gemcitabine, nab-paclitaxel and paclitaxel 16. a patient with direct tumor invation to the intestine diagnosed by endoscopy or CT scan 17. a patient who cannot give appropriate informed consent other severe medical conditions; contraindication of Gemcitabine, nabpaclitaxel or Paclitaxel, or Pregnant woman
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Overall survival | — |
Secondary
| Measure | Time frame |
|---|---|
| Response rate, rate of negative peritoneal washing cytology, resectability, dose intensity, progression-free survival, rate of alleviating cancer symposium, rate of decreased tumor marker level, safety (adverse event profile etc.) etc. | — |
Countries
Japan
Contacts
Public ContactTomohisa Yamamoto
Knasai Medical University Department of Surgery
Outcome results
None listed