NCT02148549

Neoadjuvant FIRINOX for Borderline Resectable Pancreatic Cancer - a Pilot Study

The Pilot Study of Neoadjuvant Chemotherapy of FIRINOX for Patients With Borderline Resectable Pancreatic Cancer

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 10 (actual)
• Sponsor: Wakayama Medical University · Academic / Other
• Sex: All
• Age: 20 Years – 74 Years
• Healthy volunteers: Not accepted

Summary

FOLFIRINOX regimen was recently presented at an international oncology meeting and represents a new standard regimen in the treatment of metastatic pancreatic cancer. FOLFIRINOX is one of the high response rate treatment regimen , the investigators considered as a promising treatment as neoadjuvant chemotherapy . On the other hand , incidences of grade 3 or 4 neutropenia , febrile neutropenia and diarrhea were significantly higher in the FOLFIRINOX group compared with gemcitabine group. Therefore, it was decided to consider the balance of safety and efficacy as a preoperative chemotherapy, the investigators use the FIRINOX regimen by eliminating LV and bolus 5-FU, and irinotecan reduced to 150mg/m2 of 180mg/m2 from FOLFIRINOX regimen

Detailed description

FOLFIRINOX regimen was recently presented at an international oncology meeting and represents a new standard regimen in the treatment of metastatic pancreatic cancer. FOLFIRINOX is one of the high response rate treatment regimen , the investigators considered as a promising treatment as neoadjuvant chemotherapy . On the other hand , incidences of grade 3 or 4 neutropenia , febrile neutropenia and diarrhea were significantly higher in the FOLFIRINOX group compared with gemcitabine group. Therefore, it was decided to consider the balance of safety and efficacy as a preoperative chemotherapy, the investigators use the FIRINOX regimen by eliminating LV and bolus 5-FU, and irinotecan reduced to 150mg/m2 of 180mg/m2 from FOLFIRINOX regimen. The investigators also evaluate the optimal treatment schedule of FIRINOX therapy as neoadjuvant chemotherapy, optimal duration between surgery and chemotherapy, R0 resection rate, and resection rate for borderline resectable pancreatic cancer.

Conditions

• Patients With Borderline Resectable Pancreatic Cancer

Interventions

Type	Name	Description
DRUG	FIRINOX	FIRINOX regimen by eliminating LV and bolus 5-FU, and irinotecan reduced to 150mg/m2 of 180mg/m2 from FOLFIRINOX regimen.

Timeline

• Start date: 2014-04-01
• Primary completion: 2017-02-01
• Completion: 2017-02-01
• First posted: 2014-05-28
• Last updated: 2019-10-07

Locations

9 sites across 1 country: Japan