Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 9:19 PM
Ignite Modification Date:
2025-12-24 @ 9:19 PM
NCT ID:
NCT00418704
Eligibility Criteria:
Inclusion Criteria:
* Age \> 65 years
* Comorbidities score,
* PS frailty score\*\*.according to(TABLE N°1)
* No dementia, repeated falls, faecal or urinary incontinence, ADL=0, IADL=0
* Life expectancy at least 12 weeks
* Créatinine clearance de la créatinine \> or =30cc/mn according to Cockrofts
* Gault formula
* Competency to give written informed consent
* Haematological function as follows: absolute neutrophil count \> 1.5 x 109/l and/or platelet\> 100 x 109/l, hémoglobine \> or = 9,5 g/dl
* Hepatic function as followed :bilirubin \<1,25 LNS SGOT/SGPT \<5 x N,PAL \<5N
* PS \< 3
* No symptomatic cerebral metastasis
* Histologically or cytologically confirmed NSCLC
* Stage IV/IIIB4 (T4with pleural effusion)
* No prior chemotherapy for NSCLC
* Relapses of previous NSCLC treated by surgery or radiotherapy are eligible if the target is measurable out of initial radiotherapy field and if histological or cytological proof
* At least one measurable target lesion by RECIST guidelines.
Exclusion Criteria:
* Symptomatic cerebral metastasis
* Any severe co-morbidity calculated by Charlson score (according to table 1), any kind of disorder that compromises the ability of the subject to give written informed and/or comply with the study procedure ADL \> or = 1 et IADL \> or =1 Dementia, repeated falls, faecal or urinary incontinence- Peripheral neuropathy grade 2 or more
* Performance Status \> 2 ( ECOG)- Contraindication to corticosteroids
* Unwilling or unable to comply with study requirements for personal , family, sociologic, geographic or any reasons
* Lack of liberty following administrative or judicial decision
* Hypersensitivity to polysorbate
* Hypersensitivity to erlotinib or any excipients of this product
* Unusual hereditary disorders as galactosemia, deficit in lactase and malabsorption in glucose or galactose
* Participation in concomitant clinical trial
* Contraindication to a product of this study disease
* Bronchioloalvéolar or neuroendocrine or composite carcinoma
* Superior vena cava syndrome
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
65 Years
Study:
NCT00418704
Study Brief:
Protocol Section:
NCT00418704