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

• Sponsor: Second Affiliated Hospital, School of Medicine, Zhejiang University (Other)
• Overall Status: Completed
• CT.gov ID: NCT03469375
• Collaborator: (none)
• Enrollment: 41
• Location: 1
• Actual Duration (Months): 43
• Patients Per Site Per Month: 1

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Pancreatic Cancer; Chemotherapy Effect; Surgery--Complications	Drug: modified-FOLFIRINOX

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 Design

• Study Type: Observational
• Actual Enrollment: 41 participants
• Observational Model: Case-Control
• Time Perspective: Prospective
• Official Title: Modified-FOLFIRINOX Regimen Based Neoadjuvant Therapy in Chinese Patients With Locally Advanced Pancreatic Cancer
• Actual Study Start Date: Apr 1, 2014
• Actual Primary Completion Date: Nov 1, 2017
• Actual Study Completion Date: Nov 1, 2017

Arms and Interventions

Arm	Intervention/Treatment
LAPC patients with mFOFLRINOX-based neoadjuvant therapy 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; Other Names: Neoadjuvant therapy

Outcome Measures

Primary Outcome Measures

1. Overall survival [2014-04-01 to 2017-11-01]

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

2. 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

1. Response to mFOLFIRINOX [2014-04-01 to 2017-11-01]

2. mFOLFIRINOX related adverse events [2014-04-01 to 2017-11-01]

3. Postoperative complications [2014-04-01 to 2017-11-01]

4. Histopathologic staging [2014-04-01 to 2017-11-01]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 85 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	the second affiliated hospital of Zhejiang University	Hangzhou	Zhejiang	China	310009

Sponsors and Collaborators

• Second Affiliated Hospital, School of Medicine, Zhejiang University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Second Affiliated Hospital, School of Medicine, Zhejiang University
• ClinicalTrials.gov Identifier: NCT03469375
• Other Study ID Numbers: SAHZhejiangU-FOL
• First Posted: Mar 19, 2018
• Last Update Posted: Mar 27, 2018
• Last Verified: Apr 1, 2014

• Individual Participant Data (IPD) Sharing Statement: Undecided
• Plan to Share IPD: Undecided
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Second Affiliated Hospital, School of Medicine, Zhejiang University: FOLFIRINOX; Pancreatic cancer; Conversion surgery; Overall survival
• Additional relevant MeSH terms: Pancreatic Neoplasms; Folfirinox

Study Results

No Results Posted as of Mar 27, 2018