Phase II study of neoadjuvant chemotherapy of gemcitabine+nab-paclitaxel therapy for patients with borderline resectable pancreatic cancer.

Not Applicable

Completed

• Conditions: Invasive ductal adenocarcinoma

• Registration Number: JPRN-UMIN000024154
• Lead Sponsor: Wakayama Medical University

Brief Summary

Primary endpoint: Overall survival (median) 25.2 months. Secondary endpoints: Recurrence-free survival: 12.3 months Response rate of preoperative chemotherapy: 61 target cases, antitumor effect CR 0, PR 17, SD 36, PD 8, NE 0. 17 successful cases, 27.9% response rate Primary endpoint: Overall survival (median) 25.2 months. Secondary endpoints: Recurrence-free survival: 12.3 months

Detailed Description

Not available

Study Timeline

• Study Start: 2016-10-01
• Study Completion: 2021-10-04
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: Complete: follow-up complete
• Sex: All
• Target Recruitment: 62

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.Interstitial pneumonia or pulmonary fibrosis 6.With uncontrollable pleural effusion or ascites 7.With uncontrollable diabetes mellitus 8.With uncontrollable heart failure, angina, hypertension, arrhythmia 9.With severe neurological/psychological symptoms 10.With watery diarrhea 11.Pregnant or lactating women or women with unknown or suspected pregnancy 12.Inappropriate patients for entry on this study in the judgement of the investigator 13.Diagnosed as Resectable/Unresectable pancreatic carcinoma on NCCN guideline (Version 2.2016)

Study & Design

• Study Type: Interventional
• Study Design: Not specified