Clinical trial NCT02148549: 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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Patients With Borderline Resectable Pancreatic Cancer
Keywords: Borderline resectable pancreatic cancer
R0 resection
Resection rate
Optimal schedule
Lead sponsor: Wakayama Medical University
Sponsor class: OTHER
First posted: 2014-05-28
Enrollment: 10
Sex: ALL
Minimum age (years): 20
Maximum age (years): 74
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

Eligibility criteria: Inclusion Criteria:

* Pathologically proven invasive pancreatic ductal carcinoma
* Cases that meet the definition of borderline resectable pancreatic cancer 1) or 2)

  1. Definition of a borderline resectable pancreatic cancer is filledin NCCN guideline version 1.2014 pancreatic adenocarcinoma
  2. Patients indicated distal pancreatectomy with en bloc celiac axis resection
* PS (ECOG) 0-1
* ≧20 years old and \< 75 years old
* First line treatment
* The following criteria must be satisfied in laboratory tests within 14 days of registration White blood cell count ≦12,000/mm3 Neutrophil count ≧1,500/mm3 Platelet count ≧100,000mm3 Total bilirubin \<2.0mg/dL Serum Creatinine ≦upper limits of normal(ULN) AST, ALT≦2.5×ULN Albumin≧3.0g/dL Hemoglobin≧9.0g/dL
* Written informed consent to participate in this study

Exclusion Criteria:

* Severe drug hypersensitivity
* Multiple primary cancers within 5 years
* Severe infection
* With grade2 or more severe peripheral neuropathy
* With intestinal paralysys, ileus
* Interstitial pneumonia or pulmonary
* With uncontrollable pleural effusion or ascites
* Receiving atazanavir sulfate
* With uncontrollable diabetes
* With uncontrollable heart failure, angina, hypertension, arrhythmia
* With severe psychological symptoms
* With watery diarrhea
* Pregnant or lactating women, or women with known or suspected pregnancy
* Inappropriate patients for entry on this study in the judgment of the investigator
* With UGT1A1\*28 and/or UGT1A1\*6 polymorphisms

Primary outcomes:
measure: Number of participants with toxicity of FIRINOX therapy as neoadjuvant chemotherapy for borderline resectable pancreatic cancer.
timeFrame: Up to 30 weeks.
Secondary outcomes:
measure: The resection rate of FIRINOX therapy as neoadjuvant chemotherapy for borderline resectable pancreatic cancer.
timeFrame: Up to 24 weeks.
measure: The R0 resection rate of FIRINOX therapy as neoadjuvant chemotherapy for borderline resectable pancreatic cancer.
timeFrame: Up to 30 weeks.
measure: The optimal treatment schedule of FIRINOX therapy as neoadjuvant chemotherapy for borderline resectable pancreatic cancer.
timeFrame: Up to 2 years.
Other outcomes:
Locations:
city: Nagoya
country: Japan
facility: Nagoya University
state: Aichi
city: Kobe
country: Japan
facility: Kobe University
state: Hyogo
city: Kashihara
country: Japan
facility: Nara Prefectual Medical University
state: Nara
city: Hirakata
country: Japan
facility: Kansai Medical University
state: Osaka
city: Suita
country: Japan
facility: Osaka University
state: Osaka
city: Hiroshima
country: Japan
facility: Hiroshima University
city: Osaka
country: Japan
facility: Osaka City University
city: Osaka
country: Japan
facility: Osaka Medical Center for Cancer and CVD
city: Wakayama
country: Japan
facility: Wakayama Medical University
Study officials:
affiliation: Wakayama Medical University
name: Hiroki Yamaue, M.D., PhD
role: PRINCIPAL_INVESTIGATOR
References: