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Brief Title: Neoadjuvant FIRINOX for Borderline Resectable Pancreatic Cancer - a Pilot Study
Official Title: The Pilot Study of Neoadjuvant Chemotherapy of FIRINOX for Patients With Borderline Resectable Pancreatic Cancer
Study ID: NCT02148549
Brief 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.
Minimum Age: 20 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Nagoya University, Nagoya, Aichi, Japan
Kobe University, Kobe, Hyogo, Japan
Nara Prefectual Medical University, Kashihara, Nara, Japan
Kansai Medical University, Hirakata, Osaka, Japan
Osaka University, Suita, Osaka, Japan
Hiroshima University, Hiroshima, , Japan
Osaka City University, Osaka, , Japan
Osaka Medical Center for Cancer and CVD, Osaka, , Japan
Wakayama Medical University, Wakayama, , Japan
Name: Hiroki Yamaue, M.D., PhD
Affiliation: Wakayama Medical University
Role: PRINCIPAL_INVESTIGATOR