An observational study in Pancreatic Cancer, Chemotherapy Effect and Surgery--Complications, sponsored by Second Affiliated Hospital, School of Medicine, Zhejiang University. Completed at 1 site in China. Open to participants aged 18 Years to 85 Years. Per ClinicalTrials.gov, last updated 2018-03-27.
Sponsored by Second Affiliated Hospital, School of Medicine, Zhejiang University · Observational
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.
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.
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.
Exclusion Criteria:
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.
Drug: modified-FOLFIRINOX
LAPC patients with mFOLFIRINOX-based neoadjuvant therapy or not was set as the main intervention
Also known as: Neoadjuvant therapy
Overall survival
the duration from the date of hospital admission to death of any cause.
Time frame: 2014-04-01 to 2017-11-01
Progression free survival
the duration from the date of hospital admission to disease progression or death.
Time frame: 2014-04-01 to 2017-11-01
Response to mFOLFIRINOX
Time frame: 2014-04-01 to 2017-11-01
mFOLFIRINOX related adverse events
Time frame: 2014-04-01 to 2017-11-01
Postoperative complications
Time frame: 2014-04-01 to 2017-11-01
Histopathologic staging
Time frame: 2014-04-01 to 2017-11-01
Plan to share: Undecided
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Second Affiliated Hospital, School of Medicine, Zhejiang University