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

Pancreatic Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03469375
• Other study ID #: SAHZhejiangU-FOL
• Status: Completed
• First received: March 12, 2018
• Last updated: March 25, 2018
• Start date: April 1, 2014
• Est. completion date: November 1, 2017

Study information

• Verified date: April 2014
• Source: Second Affiliated Hospital, School of Medicine, Zhejiang University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 41
• Est. completion date: November 1, 2017
• Est. primary completion date: November 1, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 85 Years

Eligibility

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

Related Conditions & MeSH terms

• Chemotherapy Effect
• Pancreatic Cancer
• Pancreatic Neoplasms
• Surgery--Complications

Intervention

Drug:
• modified-FOLFIRINOX
LAPC patients with mFOLFIRINOX-based neoadjuvant therapy or not was set as the main intervention

Locations

Country	Name	City	State
China	the second affiliated hospital of Zhejiang University	Hangzhou	Zhejiang

Sponsors (1)

Lead Sponsor	Collaborator
Second Affiliated Hospital, School of Medicine, Zhejiang University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Overall survival	the duration from the date of hospital admission to death of any cause.	2014-04-01 to 2017-11-01
Primary	Progression free survival	the duration from the date of hospital admission to disease progression or death.	2014-04-01 to 2017-11-01
Secondary	Response to mFOLFIRINOX		2014-04-01 to 2017-11-01
Secondary	mFOLFIRINOX related adverse events		2014-04-01 to 2017-11-01
Secondary	Postoperative complications		2014-04-01 to 2017-11-01
Secondary	Histopathologic staging		2014-04-01 to 2017-11-01