Phase III study of S-1 plus intravenous and introperitoneal paclitaxel for pancreatic ductal adenocarcinoma patients with peritoneal metastasis
- Conditions
- pancreatic ductal adenocarcinoma patients with peritoneal metastasis
- Registration Number
- JPRN-UMIN000027229
- Lead Sponsor
- Study group of pancreatic cancer with peritoneal metastasis
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 180
Not provided
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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Overall survival
- Secondary Outcome Measures
Name Time Method 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.