Patients With Borderline Resectable Pancreatic Cancer Clinical Trial
— FIRINOXOfficial title:
The Pilot Study of Neoadjuvant Chemotherapy of FIRINOX for Patients With Borderline Resectable Pancreatic Cancer
| Verified date | July 2015 |
| Source | Wakayama Medical University |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
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
| Status | Completed |
| Enrollment | 10 |
| Est. completion date | February 2017 |
| Est. primary completion date | February 2017 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 20 Years to 74 Years |
| Eligibility |
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 |
| Country | Name | City | State |
|---|---|---|---|
| Japan | Kansai Medical University | Hirakata | Osaka |
| Japan | Hiroshima University | Hiroshima | |
| Japan | Nara Prefectual Medical University | Kashihara | Nara |
| Japan | Kobe University | Kobe | Hyogo |
| Japan | Nagoya University | Nagoya | Aichi |
| Japan | Osaka City University | Osaka | |
| Japan | Osaka Medical Center for Cancer and CVD | Osaka | |
| Japan | Osaka University | Suita | Osaka |
| Japan | Wakayama Medical University | Wakayama |
| Lead Sponsor | Collaborator |
|---|---|
| Wakayama Medical University |
Japan,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Number of participants with toxicity of FIRINOX therapy as neoadjuvant chemotherapy for borderline resectable pancreatic cancer. | Toxicities will be assessed according to Common Terminology Criteria for Adverse Events (CTCAE) 4.0. | Up to 30 weeks. | |
| Secondary | The resection rate of FIRINOX therapy as neoadjuvant chemotherapy for borderline resectable pancreatic cancer. | Up to 24 weeks. | ||
| Secondary | The R0 resection rate of FIRINOX therapy as neoadjuvant chemotherapy for borderline resectable pancreatic cancer. | Up to 30 weeks. | ||
| Secondary | The optimal treatment schedule of FIRINOX therapy as neoadjuvant chemotherapy for borderline resectable pancreatic cancer. | Up to 2 years. |