Phase I study of neoadjuvant chemotherapy of gemcitabine plus nab-paclitaxel for patients with borderline resectable pancreatic cancer

Phase 1

• Conditions: Invasive ductal carcinoma

• Registration Number: JPRN-UMIN000018382
• Lead Sponsor: Wakayama Medical University

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2015-07-22
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: Complete: follow-up complete
• Sex: All
• Target Recruitment: 10

Inclusion Criteria

Not provided

Exclusion Criteria

1. Severe drug hypersensitivity 2. Multiple primary cancers within 5 years 3. Severe infection 4. With grade2 or more severe peripheral neuropathy 5. With intestinal paralysys, ileus 6. Interstitial pneumonia or pulmonary 7. With uncontrollable pleural effusion or ascites 8. Receiving atazanavir sulfate 9. With uncontrollable diabetes 10.With uncontrollable heart failure, angina, hypertension, arrhythmia 11.With severe psychological symptoms 12.With watery diarrhea 13.Pregnant or lactating women, or women with known or suspected pregnancy 14.Inappropriate patients for entry on this study in the judgment of the investigator

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Adverse event

Secondary Outcome Measures

Name	Time	Method
1. R0 resection rate 2. Resection rate 3. Optimal duration before surgery to perform neoadjuvant chemotherapy 4. QOL evaluation about peripheral neuropathy using FACT-NTX(Version4)