A Pilot Study of Pre- and Post-surgery Chemotherapy With mFOLFIRINOX in Localized, Resectable Pancreatic Adenocarcinoma
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|ClinicalTrials.gov Identifier: NCT01660711|
Recruitment Status : Active, not recruiting
First Posted : August 9, 2012
Last Update Posted : October 25, 2017
|Condition or disease||Intervention/treatment||Phase|
|Pancreatic Adenocarcinoma||Drug: 5 Fluorouracil Drug: Leucovorin Drug: Irinotecan Drug: Oxaliplatin||Phase 2|
Show Detailed Description
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||21 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Pilot Study of Neoadjuvant and Adjuvant mFOLFIRINOX in Localized, Resectable Pancreatic Adenocarcinoma|
|Study Start Date :||July 2012|
|Estimated Primary Completion Date :||March 2018|
|Estimated Study Completion Date :||July 2018|
Experimental: FOLFIRINOX chemotherapy
5FU 2400 mg/m2 IV over 48 hours Irinotecan 180 mg/m2 IV day 1 Oxaliplatin 85 mg/m2 IV day 1 Leucovorin 400 mg/m2 IV day 1
Cycles administered every 14 days for 4 cycles before and 4 cycles after surgery.
Drug: 5 Fluorouracil
2400 mg/m2 by continuous intravenous infusion over 46 hours
Other Name: Adrucil,5FU
400 mg/m2 by IV infusion over 2 hours
Other Name: Folinic acid, Wellcovorin, citrovorum factor
180 mg/m² IV infusion on Day 1 over 90-120 minutes (infusion via a Y connector during the infusion of leucovorin)
Other Name: camptosar, CPT11
85 mg/m² IV infusion on Day 1 over 2 hours
Other Name: Eloxatin,
- The percentage of patients able to complete the full course of preoperative chemotherapy and undergo a resection. [ Time Frame: Following completion of all planned therapy, an expected average of 4 months ]
The percentage of patients able to complete the full course of preoperative chemotherapy and undergo a resection. This will be the primary determinant of success for this pilot study.
Early withdrawals due to toxicity, disease progression, or intercurrent illness will be considered failures.
- The percentage of patients able to complete the full course of therapy, including preoperative chemotherapy, surgical resection and postoperative chemotherapy. [ Time Frame: On completion of all planned therapy, an expected average of 8 months ]
- Treatment related toxicity and other adverse events (AEs) during Toxicity of preoperative and postoperative therapy and the safety of this approach. [ Time Frame: 1 year ]
- R0 resection rate. [ Time Frame: 3 months ]Assessment of the percentage of patients able to have an R0 resection following preoperative chemotherapy.
- Progression-free survival and overall survival from the start of study treatment. [ Time Frame: 5 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): NCT01660711
|United States, Illinois|
|NorthShore University HealthSystem|
|Evanston, Illinois, United States, 60201|