Fluorouracil and Oxaliplatin as First-line for Advanced Pancreatic Cancer (PanFLOX)
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|ClinicalTrials.gov Identifier: NCT02896803|
Recruitment Status : Recruiting
First Posted : September 12, 2016
Last Update Posted : January 25, 2019
|Condition or disease||Intervention/treatment||Phase|
|Pancreatic Neoplasms||Drug: mFLOX||Phase 2|
Currently, FOLFIRINOX is considered the standard treatment for PS 0 or 1 patients with advanced pancreatic carcinoma. However, due to excessive toxicity dose reductions and interruptions in the treatment toxicity are frequent. So, for those not eligible patients (PS 2 or 3, hyperbilirubinemia, among other causes), alternative schemes as gemcitabine alone are the standard approach .
This study aims to evaluate the efficacy and safety of the mFLOX regimen (fluorouracil bolus and oxaliplatin) as first-line regimen for advanced pancreatic adenocarcinoma not eligible for FOLFIRINOX.
The primary endpoint is to assess the objective response rate according to RECIST criteria (version 1.1) and the secondary endpoints are time until clinical or radiological progression, overall survival, toxicity profile.
It has been estimated an n=34 for a response rate of 20%, compared to the historical control of 7% with gemcitabine alone (Von Hoff et al.), with an alpha error of 5% and power of 80%. Considering a rate of 10% of dropout, our sample will be 37 patients.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||37 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase II Trial of Bolus Fluorouracil and Oxaliplatin (mFLOX) as First-line Regimen for Patients With Unresectable or Metastatic Pancreatic Cancer Not Eligible for Infusional Fluorouracil, Irinotecan and Oxaliplatin|
|Study Start Date :||August 2016|
|Estimated Primary Completion Date :||December 2019|
|Estimated Study Completion Date :||June 2020|
5-fluorouracil 500 mg/m2 and folinic acid 20 mg/m2 infused both bolus weekly for 6 weeks (d1, 8,15, 22, 29 and 36) and oxaliplatin 85 mg / m2 infused over 2 hours at weeks 1,3 and 5 (d1,15 and 29). The scheme will be repeated every 8 weeks.
Other Name: 5-fluorouracil and oxaliplatin
- Response rate [ Time Frame: Through the study, every 14-16 weeks, until an average of 6 months ]Response rate will be evaluated according RECIST criteria version 1.1
- Time to progression [ Time Frame: Through the study, every 14-16 weeks, until an average of 6 months ]CT scans will be performed every 14-16 weeks, until disease progression (according to RECIST criteria version 1.1) or death, an average of 6 months.
- Overall survival [ Time Frame: Through the study, an average of 10 months ]It is defined as a time between entry in the trial and death
- Toxicities according CTCAE v4.03 [ Time Frame: Through the treatment, every visit, an average of 6 months ]Toxicities will be evaluated every visit, according CTCAE v4.03
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): NCT02896803
|Contact: Tiago Castria, MD PhDemail@example.com|
|Instituto do Câncer do Estado de São Paulo||Recruiting|
|São Paulo, Brazil, 01246-000|
|Contact: Tiago Castria, MD PhD +5511 3893-2000 firstname.lastname@example.org|
|Principal Investigator:||Tiago Castria, MD PhD||Instituto do Cancer do Estado de São Paulo|