Clinical trial NCT03469375: Modified-FOLFIRINOX Regimen Based Neoadjuvant Therapy in Chinese Patients With Locally Advanced Pancreatic Cancer
Official title: Modified-FOLFIRINOX Regimen Based Neoadjuvant Therapy in Chinese Patients With Locally Advanced Pancreatic Cancer
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Pancreatic Cancer
Chemotherapy Effect
Surgery--Complications
Keywords: FOLFIRINOX
Pancreatic cancer
Conversion surgery
Overall survival
Lead sponsor: Second Affiliated Hospital, School of Medicine, Zhejiang University
Sponsor class: OTHER
First posted: 2018-03-19
Enrollment: 41
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All locally advanced pancreatic cancer (LAPC) patients are diagnosed by histology to have pancreatic adenocarcinoma after a biopsy and prescribed mFOLFIRINOX-based neoadjuvant therapy at the Department of Hepatobiliary and Pancreatic Surgery of the Second Affiliated Hospital.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Overall survival
timeFrame: 2014-04-01 to 2017-11-01
measure: Progression free survival
timeFrame: 2014-04-01 to 2017-11-01
Secondary outcomes:
measure: Response to mFOLFIRINOX
timeFrame: 2014-04-01 to 2017-11-01
measure: mFOLFIRINOX related adverse events
timeFrame: 2014-04-01 to 2017-11-01
measure: Postoperative complications
timeFrame: 2014-04-01 to 2017-11-01
measure: Histopathologic staging
timeFrame: 2014-04-01 to 2017-11-01
Other outcomes:
Locations:
city: Hangzhou
country: China
facility: the second affiliated hospital of Zhejiang University
state: Zhejiang
Study officials:
References: