Modified-FOLFIRINOX Regimen Based Neoadjuvant Therapy in Chinese Patients With Locally Advanced Pancreatic Cancer

Completed

• Conditions: Pancreatic Cancer; Chemotherapy Effect; Surgery--Complications
• Interventions: Drug: modified-FOLFIRINOX

• Registration Number: NCT03469375
• Lead Sponsor: Second Affiliated Hospital, School of Medicine, Zhejiang University

Brief Summary

FOLFIRINOX regimen is first-line neoadjuvant chemotherapies for patients with locally advanced pancreatic cancer (LAPC) worldwide. However, FOLFIRINOX is not well accepted in China because of the high prevalence of adverse events and poor tolerance. To evaluate the safety and efficacy of modified-FOLFIRINOX (mFOLFIRINOX) in Chinese LAPC patients and compare survival between LAPC patients with mFOLFIRINOX-based preoperative therapy and LAPC patients who underwent surgery alone.

Detailed Description

At this institution, a mFOLFIRINOX regimen has been adopted for metastatic pancreatic cancer (MPC) patients and promising results obtained. The modification resulted in a significantly reduced prevalence of severe adverse events in MPC patients, whereas the OS and PFS were extended to 10.3m and 7.0m, respectively, which is similar to that for patients on a full-dose regimen. Therefore, the investigators further evaluated the efficacy of mFOLFIRINOX in LAPC patients. Here, investigators want to prospectively enroll LAPC patients who underwent preoperative therapy with mFOLFIRINOX from April 2014 and compared the surgical resectability and surgical morbidity/surgical mortality among patients with surgically resectable pancreatic cancer (RPC) or LAPC who underwent surgery alone retrospectively. For patients with LAPC, mFOLFIRINOX was administrated for several cycles until the optimal response was obtained and then patients were evaluated for surgery. Moreover, survival data, including OS and PFS, were determined.

Study Timeline

• Status Verified: 2014-04
• Study Start: 2014-04-01
• Primary Completion: 2017-11-01
• Study Completion: 2017-11-01
• Study First Submitted: 2018-03-12
• Study First Submitted QC: 2018-03-12
• Study First Posted: 2018-03-19
• Last Update Submitted: 2018-03-25
• Last Update Posted: 2018-03-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 41

Inclusion Criteria

1. The patients are diagnosed by histology to have pancreatic adenocarcinoma
2. The patients are defined as locally advanced pancreatic cancer according to NCCN guideline
3. The patients prescribed mFOLFIRINOX-based neoadjuvant therapy

Exclusion Criteria

1. ECOG performance score more than 2
2. Insufficient bone marrow, liver and renal function
3. Patients with other malignancies
4. Patients were older than 85 years or less than 18 years

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
LAPC patients with mFOFLRINOX-based neoadjuvant therapy	modified-FOLFIRINOX	LAPC patients were enrolled prospectively and diagnosed by MDT group in our hospital. These patients further received the neoadjuvant therapy with mFOLFIRINOX, the Overall survival, Progression survival, response to mFOLFIRINOX, chemo-related Toxicities, Postoperative complications and Histopathologic staging were measured.

Primary Outcome Measures

Name	Time	Method
Overall survival	2014-04-01 to 2017-11-01	the duration from the date of hospital admission to death of any cause.
Progression free survival	2014-04-01 to 2017-11-01	the duration from the date of hospital admission to disease progression or death.

Secondary Outcome Measures

Name	Time	Method
Postoperative complications	2014-04-01 to 2017-11-01
Histopathologic staging	2014-04-01 to 2017-11-01
Response to mFOLFIRINOX	2014-04-01 to 2017-11-01
mFOLFIRINOX related adverse events	2014-04-01 to 2017-11-01

Trial Locations

Locations (1)

the second affiliated hospital of Zhejiang University; 🇨🇳 Hangzhou, Zhejiang, China