Phase I/II study of Second-lIne therapy of preoperative cheMoradiothERApy with gemcitabine and nab-paclitaxel for locally advanced pancreatic canceR (SIMERAR trial)
- Conditions
- Patients with locally advanced pancreatic cancer (BR-A or UR-LA) scheduled for pancreatic resection
- Registration Number
- JPRN-UMIN000046618
- Lead Sponsor
- Department of Surgery and Science, Faculty of Medicine, Academic Assembly, University of Toyama
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 45
Not provided
1) Active multiple cancers 2) Patients whose dose of GEM+nab-PTX in primary chemotherapy was reduced to less than 600 mg/m2 of GEM or less than 75 mg/m2 of nab-PTX 3) Patients who were refractory or intolerant to primary GEM+nab-PTX and were switched to other chemotherapy 4) Infection or inflammation that requires systemic treatment 5) Fever of 38.0 degrees Celsius higher at the time of registration 6) Allergy or contraindication to gemcitabine or paclitaxel 7) History of severe drug hypersensitivity or drug allergy 8) Allergy to contrast media 9) History of serious heart disease 10) History of serious underlying diseases (poorly controlled diabetes, renal failure, liver cirrhosis, etc.) 11) Poorly controlled ascites or pleural effusion 12) Active gastrointestinal bleeding requiring repeated blood transfusions. 13) Diarrhea (more than 4 times a day or watery stools) 14) Poorly controlled cancer pain 15) Pulmonary fibrosis or interstitial pneumonia with obvious or clinical findings on imaging 16) Lung field enters the radiation field 17) Pregnant or lactating women or those with the potential (intention) to become pregnant 18) Severe psychological or neurological disease 19) Unable to give consent to participate in this study
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Phase I study: Incidence of dose-limiting toxicities (DLT) Phase II study: 2-year survival rate
- Secondary Outcome Measures
Name Time Method Phase I study: Response rate Disease control rate Safety (incidence and severity of adverse events) Phase II study: Overall survival Progression-free survival Response rate Disease control rate Tumor marker decrease rate Surgical procedure Intraoperative blood loss Operation time Resection rate R0 resection rate Incidence of postoperative pancreatic fistula Postoperative hemorrhage Incidence of DGE Incidence of diarrhea Other postoperative complications Safety (incidence and severity of adverse events)