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:
2025-12-26 @ 10:58 AM
Ignite Modification Date:
2025-12-26 @ 10:58 AM
NCT ID:
NCT00969306
Eligibility Criteria:
Inclusion Criteria:
* Histologically or cytologically confirmed ''extensive disease'' (Stage T0-4 N0-3 M1) small cell lung cancer
* At least one measurable disease site, defined as lesion of ≥ 1 cm unidimensionally on CT-scan.
* WHO performance status 0-2
* Absolute neutrophil count at least 1800/µl and platelets at least 100000/µl and hemoglobin at least 6.2 mmol/l.
* Calculated creatinine clearance at least 60 ml/min
* Adequate hepatic function: Total bilirubin ≤ 1.5 x upper limit of normal (ULN) for the institution; ALT, AST, and alkaline phosphatase ≤ 2.5 x ULN for the institution (in case of liver metastases ≤ 5 x ULN for the institution)
* No previous platinum chemotherapy or topo-isomerase-inhibitors for SCLC.
* Life expectancy more than 6 months
* Willing and able to comply with the study prescriptions
* 18 years or older
* Not pregnant or breast feeding and willing to take adequate contraceptive measures during the study
* Ability to give and having given written informed consent before patient registration
* No mixed pathology, e.g. non-small cell plus small cell cancer
* No recent (\< 3 months) severe cardiac disease (NYHA class \>1) (congestive heart failure, infarction)
* No history of cardiac arrythmia (multifocal premature ventricular contractions, uncontrolled atrial fibrillation, bigeminy, trigeminy, ventricular tachycardia) which is symptomatic and requiring treatment (CTC AE 4.0), or asymptomatic sustained ventricular tachycardia. Asymptomatic atrial fibrillation controlled on medication is allowed.
* No cardiac conduction disturbances or medication potentially causing them:
* QTc interval prolongation with other medications that required discontinuation of the treatment
* Congenital long QT-syndrome or unexplained sudden death of first degree relative under 40 years of age
* QTc interval \> 480 msec (note: when this is the case on screening ECG, the ECG may be repeated twice. If the average QT-interval of these 3 measurements remains below 480 msec, patient is eligible)
* Patients on medication potentially prolongating the QT-interval are excluded if the QT-interval is \> 460 msec (Appendix, table 2).
* Medication that might cause QT-prolongation or Torsades de pointes tachycardia is not allowed (Appendix, Table 1). Drugs with a risk of prolongating the QT-interval that cannot be discontinued are allowed, however, under close monitoring by the treating physician (Appendix, table 2).
* No uncontrolled infectious disease
* No other active malignancy
* No major surgery (excluding diagnostic procedures like e.g., mediastinoscopy) in previous 4 weeks
* No treatment with investigational drugs in 4 weeks prior to or during this study
* No chronic systemic immune therapy
* No known G6PD deficiency
Exclusion Criteria:
* The opposite of the above
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
100 Years
Study:
NCT00969306
Study Brief:
Protocol Section:
NCT00969306