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

• Sponsor: Nagoya University (Other)
• Overall Status: Active, not recruiting
• CT.gov ID: NCT02717091
• Collaborator: (none)
• Enrollment: 50
• Arms: 2
• Duration (Months): 95

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Borderline Resectable Pancreatic Cancer	Drug: FOLFIRINOX; Drug: gemcitabine + nab-paclitaxel	Phase 2

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 50 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Phase II Study of Neoadjuvant FOLFIRINOX or Nab-paclitaxel With Gemcitabine for Borderline Resectable Pancreatic Cancer
• Study Start Date: Jul 1, 2015
• Actual Primary Completion Date: Jun 1, 2020
• Anticipated Study Completion Date: Jun 1, 2023

Arms and Interventions

Arm	Intervention/Treatment
Experimental: FOLFIRINOX 4 course of FILFIRINOX before surgery	Drug: FOLFIRINOX
Experimental: GEM + nab-PTX 2 course of GEM + nab-PTX before surgery	Drug: gemcitabine + nab-paclitaxel

Outcome Measures

Primary Outcome Measures

1. R0 resection rate [3 months]

   surgery is supposed to be performed 3 months after the initiation of chemotherapy

Secondary Outcome Measures

1. completion rate of chemotherapy [3 months]

   chemotherapy is supposed to take 3 months

2. relative dose intensity [3 months]

   chemotherapy is supposed to take 3 months

3. adverse event [3 months]

   chemotherapy is supposed to take 3 months

4. tumor response [3 months]

   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

5. disease free survival [3 years after the surgery]

6. overall survival [3 years after the surgery]

7. surgical complication [1 month after the surgery]

8. quality of the tumor [3 months]

   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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 20 Years to 75 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

• Nagoya University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Junpei Yamaguchi, Surgical Oncology, Nagoya University
• ClinicalTrials.gov Identifier: NCT02717091
• Other Study ID Numbers: NUDC1508
• First Posted: Mar 23, 2016
• Last Update Posted: Sep 10, 2020
• Last Verified: Sep 1, 2020

• Additional relevant MeSH terms: Pancreatic Neoplasms; Gemcitabine; Paclitaxel; Folfirinox

Study Results

No Results Posted as of Sep 10, 2020