Patients with non-small lung cell cancer MedDRA version: 19.0 Level: PT Classification code 10061873 Term: Non-small cell lung cancer System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Conditions
Interventions
Trade Name: ALIMTA
Product Name: ALIMTA
Pharmaceutical Form: Infusion
Sponsors
Centre Georges François Leclerc
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: •Patient over 18 years •patient with a non-small cell lung cancer predominantly non-squamous histologically documented •Patient planned to start a treatment or ongoing maintenance treatment with pemetrexed •Neutrophils> 1500 / mm3; platelets> 100,000 / mm3 •Written informed consent signed and dated •For patients of childbearing age, effective contraception •Creatinine clearance according to Cockcroft-Gault formula between 70 and 45 mL / min •PS=0 or 1 Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: •Patient contraindicated with pemetrexed treatment •Patient with symptomatic brain metastases •Pregnant or nursing women •Patient under guardianship or submitted to major people protection regime •Patient not affiliated with a social security scheme (beneficiary or beneficiary)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To assess the impact of calculating the dose of pemetrexed administered according to the creatinine clearance by Cockcroft-Gault (CrCLCG) versus depending on body surface area (BSA) on the median time to treatment discontinuation for renal function = 45mL / min in patients treated for non-small lung cell cancer predominantly non-squamous in maintenance situation;Secondary Objective: To assess the impact of calculating the dose of pemetrexed administered according to the CrCLCG versus according to the SC on the time to treatment discontinuation, progression-free survival (PFS) and overall survival (OS) of patients;Primary end point(s): The median time to treatment discontinuation for renal function = 45 mL / min (Cockcroft-Gault) is defined as the time interval between the date of randomization to treatment discontinuation date due to a creatinine clearance = 45 mL / min. Treatment stops for other reasons than a too low clearance will be censored.;Timepoint(s) of evaluation of this end point: when treatment is stopped | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): The median time to therapy discontinuation is defined as the time interval between the date of randomization and the stop date regardless of the cause. ;Timepoint(s) of evaluation of this end point: Progression-free survival is defined as the time interval between the date of randomization and the date of death from any cause or date of increase, taking into account the event occurs first. The progress will be assessed according to RECIST criteria. Progression-free survival is defined as the time interval between the date of randomization and the date of death. | — |
Countries
France
Contacts
Public ContactRederstorff
Centre Georges François Leclerc
Outcome results
None listed