Fluorouracil and Oxaliplatin as First-line for Advanced Pancreatic Cancer
NCT ID: NCT02896803
Last Updated: 2020-11-10
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE2
37 participants
INTERVENTIONAL
2016-08-31
2021-12-31
Brief Summary
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Detailed Description
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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.
Conditions
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Keywords
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Experimental
mFLOX
mFLOX
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.
Interventions
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mFLOX
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 Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Unresectable primary tumor considered by the team assistant or metastatic disease
* Aged between 18 and 75 at the time of study entry
* Naïve patients of palliative chemotherapy, admitted for treatment at the Institute of the São Paulo State Cancer (ICESP)
* Patients with performance status 0 or 1, not candidates to receive chemotherapy with FOLFIRINOX or performance status 2.
* No significant organ dysfunction defined as: Hb\> 9 g / dL, platelets\> 100,000 / microliter (mcL), neutrophils\> 1500 / mcL, clearance of creatinine (ClCr) \> 50 ml / min, total bilirubin \<5 mg/dl, serum alanine transaminase (ALT) and aspartate transaminase (AST) \<2.5 x upper limit of normal (ULN) (or \<5 x ULN if liver metastases present)
* Able to read and sign an informed consent form.
Exclusion Criteria
* Absence of histological material available to local review (eg diagnostic fine needle aspiration (FNA) or cytology)
* Previous use of radiotherapy in the primary tumor or a metastasis site that will serve as target lesion to assess response to treatment
* Diagnosis of malignancy other activity except non-melanoma skin cancer
* Clinical evidence of metastasis in the central nervous system active meningeal carcinomatosis or severe chronic disease patients (cirrhosis, heart failure New York Heart Association Functional Classification (NYHA) III or IV, chronic obstructive pulmonary disease (COPD) oxygen-dependent or chronic kidney disease requiring dialysis)
* Pregnant or breastfeeding
* Patients with HIV / AIDS story on anti-retroviral therapy
* Patients with peripheral neuropathy grade\> 2 (CTCAE v4.03)
* Medium or large surgery in the last 4 weeks. For example, biliary derivation.
18 Years
75 Years
ALL
No
Sponsors
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Instituto do Cancer do Estado de São Paulo
OTHER
Responsible Party
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Principal Investigators
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Tiago Castria, MD PhD
Role: PRINCIPAL_INVESTIGATOR
Instituto do Cancer do Estado de São Paulo
Locations
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Instituto do Câncer do Estado de São Paulo
São Paulo, , Brazil
Countries
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Central Contacts
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Facility Contacts
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Tiago Castria, MD PhD
Role: primary
Other Identifiers
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869/15
Identifier Type: -
Identifier Source: org_study_id