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

NCT03469375 | Completed

• 1 other identifier: SAHZhejiangU-FOL
• Study Type: observational
• Target: 41
• Locations: 1 country
• Sites: 1

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.

Conditions

Pancreatic Cancer; Chemotherapy Effect; Surgery--Complications

Keywords

FOLFIRINOX; Pancreatic cancer; Conversion surgery; Overall survival

Outcome Measures

Primary Outcomes (2)

• Overall survival

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

  2014-04-01 to 2017-11-01

• Progression free survival

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

  2014-04-01 to 2017-11-01

Secondary Outcomes (4)

• Response to mFOLFIRINOX

  2014-04-01 to 2017-11-01

• mFOLFIRINOX related adverse events

  2014-04-01 to 2017-11-01

• Postoperative complications

  2014-04-01 to 2017-11-01

• Histopathologic staging

  2014-04-01 to 2017-11-01

Study Arms (1)

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

Interventions

modified-FOLFIRINOX DRUG

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

Also known as: Neoadjuvant therapy

LAPC patients with mFOFLRINOX-based neoadjuvant therapy

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Second Affiliated Hospital, School of Medicine, Zhejiang University: lead

Study Sites (1)

the second affiliated hospital of Zhejiang University

Hangzhou, Zhejiang, 310009, China

Location

MeSH Terms

Conditions

Pancreatic Neoplasms

Interventions

Neoadjuvant Therapy

Condition Hierarchy (Ancestors)

Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Endocrine Gland Neoplasms; Digestive System Diseases; Pancreatic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Combined Modality Therapy; Therapeutics

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 12, 2018
• First Posted: March 19, 2018
• Study Start: April 1, 2014
• Primary Completion: November 1, 2017
• Study Completion: November 1, 2017
• Last Updated: March 27, 2018

Record last verified: 2014-04

Locations

CN (1)