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:
2025-12-25 @ 12:23 AM
Ignite Modification Date:
2025-12-25 @ 12:23 AM
NCT ID:
NCT00199758
Eligibility Criteria:
Inclusion Criteria:
* Histologically or cytologically proved stage IV or pleural stage III NSCLC (neoplastic pleurisy confirmed).
* Metastatic relapses allowed in not irradiated area.
* Age between 18 and 70 years
* Chemonaïve patients
* At least one measurable target lesion according to recist criteria in non previously irradiated area.
* Performance status \< 2
* Normal hepatic and renal function, absolute neutrophil count \>1,5 giga/l, platelets \>100 giga/l.
* Written informed consent.
* Life expectancy \> 12 weeks.
Exclusion Criteria:
* SCLC, bronchial-alveolar and neuro-endocrine carcinoma.
* Previous chemotherapeutic treatment.
* Symptomatic brain metastases.
* Superior vena cava syndrome.
* Other concomitant diseases: heart failure, angina pectoris, arrhythmia , recent myocardial infarction.
* Peripheral neuropathy grade ≥2.
* Past or concomitance of another cancer except baso-cellular carcinoma of the skin or in situ cervical carcinoma.
* Hypersensitivity to paclitaxel or polysorbate 80.
* Pregnancy or breast feeding.
* Any concomitant radiotherapy, except palliative bone irradiation.
* Follow-up of the patient impossible.
* Prisoners.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
70 Years
Study:
NCT00199758
Study Brief:
Protocol Section:
NCT00199758