Neoadjuvant FIRINOX for Borderline Resectable Pancreatic Cancer - a Pilot Study (FIRINOX)
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|ClinicalTrials.gov Identifier: NCT02148549|
Recruitment Status : Unknown
Verified July 2015 by Hiroki Yamaue, Wakayama Medical University.
Recruitment status was: Active, not recruiting
First Posted : May 28, 2014
Last Update Posted : July 23, 2015
|Condition or disease||Intervention/treatment||Phase|
|Pancreatic Cancer.||Drug: FIRINOX||Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||10 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||The Pilot Study of Neoadjuvant Chemotherapy of FIRINOX for Patients With Borderline Resectable Pancreatic Cancer|
|Study Start Date :||April 2014|
|Estimated Primary Completion Date :||February 2017|
|Estimated Study Completion Date :||February 2017|
Experimental: Optimal chemotherapy courses
Neoadjuvant chemotherapy 4 courses of FIRINOX early 5 patients, and 8 courses of FIRINOX subsequent 5 patients
FIRINOX regimen by eliminating LV and bolus 5-FU, and irinotecan reduced to 150mg/m2 of 180mg/m2 from FOLFIRINOX regimen.
Other Name: Oxaliplatin, Irinotecan, 5-FU.
- Number of participants with toxicity of FIRINOX therapy as neoadjuvant chemotherapy for borderline resectable pancreatic cancer. [ Time Frame: Up to 30 weeks. ]Toxicities will be assessed according to Common Terminology Criteria for Adverse Events (CTCAE) 4.0.
- The resection rate of FIRINOX therapy as neoadjuvant chemotherapy for borderline resectable pancreatic cancer. [ Time Frame: Up to 24 weeks. ]
- The R0 resection rate of FIRINOX therapy as neoadjuvant chemotherapy for borderline resectable pancreatic cancer. [ Time Frame: Up to 30 weeks. ]
- The optimal treatment schedule of FIRINOX therapy as neoadjuvant chemotherapy for borderline resectable pancreatic cancer. [ Time Frame: Up to 2 years. ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02148549
|Nagoya, Aichi, Japan|
|Kobe, Hyogo, Japan|
|Nara Prefectual Medical University|
|Kashihara, Nara, Japan|
|Kansai Medical University|
|Hirakata, Osaka, Japan|
|Suita, Osaka, Japan|
|Osaka City University|
|Osaka Medical Center for Cancer and CVD|
|Wakayama Medical University|
|Wakayama, Japan, 641-8510|
|Principal Investigator:||Hiroki Yamaue, M.D., PhD||Wakayama Medical University|