Neoadjuvant FOLFIRINOX or Nab-paclitaxel With Gemcitabine for Borderline Resectable Pancreatic Cancer

Borderline Resectable Pancreatic Cancer Clinical Trial

Official title:

Phase II Study of Neoadjuvant FOLFIRINOX or Nab-paclitaxel With Gemcitabine for Borderline Resectable Pancreatic Cancer

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02717091
• Other study ID #: NUDC1508
• Status: Active, not recruiting
• Phase: Phase 2
• Start date: July 2015
• Est. completion date: June 2023

Study information

• Verified date: September 2020
• Source: Nagoya University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The aim of this study is to clarify the efficacy and safety of neoadjuvant FOLFIRINOX and nab-paclitaxel + gemcitabine for borderline resectable pancreatic cancer.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 50
• Est. completion date: June 2023
• Est. primary completion date: June 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 75 Years

Eligibility

Inclusion Criteria:

1. Borderline resectable pancreatic cancer (based on NCCN guideline version 2.2015)

2. first treatment for pancreatic cancer

3. performance status 0 or 1

4. adequate one marrow function

5. adequate renal function

6. obtained informed consent

Exclusion Criteria:

1. other active concomitant malignancies

2. other severe medical conditions; contraindication of FOLFIRINOX, paclitaxel and gemcitabine

3. pregnant women

4. no informed consent

Related Conditions & MeSH terms

• Borderline Resectable Pancreatic Cancer
• Pancreatic Neoplasms

Intervention

Drug:
• FOLFIRINOX

• gemcitabine + nab-paclitaxel

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Nagoya University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	R0 resection rate	surgery is supposed to be performed 3 months after the initiation of chemotherapy	3 months
Secondary	completion rate of chemotherapy	chemotherapy is supposed to take 3 months	3 months
Secondary	relative dose intensity	chemotherapy is supposed to take 3 months	3 months
Secondary	adverse event	chemotherapy is supposed to take 3 months	3 months
Secondary	tumor response	tumor response to chemotherapy will be assessed based on Response Evaluation Criteria In Solid Tumor (RECIST). CR: Complete Response, PR: Partial Response, PD: Progression, SD: Stable Disease, NE: Not Evaluable	3 months
Secondary	disease free survival		3 years after the surgery
Secondary	overall survival		3 years after the surgery
Secondary	surgical complication		1 month after the surgery
Secondary	quality of the tumor	Chemotherapy is supposed to take 3 months. After the completion of chemotherapy, the quality of the tumor will be assessed by imaging findings, such as CT number and Standardized uptake value.	3 months