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 @ 5:51 PM
Ignite Modification Date:
2025-12-24 @ 5:51 PM
NCT ID:
NCT00633568
Eligibility Criteria:
Inclusion Criteria:
* Histological or cytological diagnosis of non-small cell carcinoma of the lung
* Initially unresectable non-metastatic stage III disease
* Availability for participating in the detailed follow-up of the protocol
* Presence of an evaluable or measurable lesion
* Written informed consent
* No functional or anatomical contraindication to chest irradiation
Exclusion Criteria:
* Prior treatment with chemotherapy, radiotherapy or surgery
* Performance status \< 60 on the Karnofsky scale
* History of prior malignant tumour, except non-melanoma skin cancer or in situ carcinoma of the cervix or cured malignant tumour (more than 5 year disease-free interval)
* Neutrophils \< 2,000/mm³
* Platelet cells \< 100,000/mm3
* Serum bilirubin \> 1.5 mg/100 ml
* Hepatic disease contra-indicating the administration of docetaxel and/or GOT or GPT ≥ 2.5x the normal value and/or alkaline phosphatase ≥ 5x the normal value
* Serum creatinine \> 1.5 mg/100 ml and/or creatinine clearance \< 60 ml/min
* Recent myocardial infarction (less than 3 months prior to date of diagnosis) or uncontrolled angina pectoris
* Congestive cardiac failure or cardiac arrhythmia requiring medical treatment
* Uncontrolled infectious disease
* Symptomatic polyneuropathy
* Auditive impairment contra-indicating cisplatin administration
* Serious medical or psychological factors which may prevent adherence to the treatment schedule
* Malignant pleural or pericardial effusion
* Homolateral supraclavicular lymph node excepting upper lobe lesion
* Heterolateral supraclavicular lymph node
* Known hypersensitivity to docetaxel or cisplatin
* Pregnancy or for pre-menopausal patient, incapacity to use adequate contraceptive method
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT00633568
Study Brief:
Protocol Section:
NCT00633568