Skip to main content
OpenTrials
Completed

NCT Number: NCT03469375

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Age range

18 year–85 year

Sex eligibility

All sexes

Study type

Observational

Primary location

the second affiliated hospital of Zhejiang University

Hangzhou, Zhejiang, 310009, China

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

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

Treatment and study plan

modified-FOLFIRINOX

Drug

LAPC patients with mFOLFIRINOX-based neoadjuvant therapy or not was set as the main intervention

Other names: Neoadjuvant therapy

Primary outcomes

  1. Overall survival

    Time frame: 2014-04-01 to 2017-11-01

    the duration from the date of hospital admission to death of any cause.

  2. Progression free survival

    Time frame: 2014-04-01 to 2017-11-01

    the duration from the date of hospital admission to disease progression or death.

Secondary outcomes

  1. Response to mFOLFIRINOX

    Time frame: 2014-04-01 to 2017-11-01

  2. mFOLFIRINOX related adverse events

    Time frame: 2014-04-01 to 2017-11-01

  3. Postoperative complications

    Time frame: 2014-04-01 to 2017-11-01

  4. Histopathologic staging

    Time frame: 2014-04-01 to 2017-11-01

Sponsors and collaborators

Lead sponsor

Second Affiliated Hospital, School of Medicine, Zhejiang University

Other

Registry information

Important dates

Study start
2014
Primary completion
2017
Study completion
2017
First posted
Mar 19, 2018
Registry last updated
Mar 27, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.