Clinical Trial Details
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NCT01486459 : A Feasibility Trial Using Lithium As A Neuroprotective Agent In Patients Undergoing Prophylactic Cranial Irradiation For Small Cell Lung Cancer
AgesMin: 18 Years Max: N/A
Inclusion Criteria:

- Histologically or cytologically confirmed high grade small cell neuroendocrine

- Patients can either have:

- Limited stage disease with CR or PR OR

- Extensive stage disease with CR or good PR

- Patients must have discontinued other chemotherapies at least 3 weeks prior to

- Prior radiation therapy to the chest is allowed but must be completed at least 3
weeks prior to randomisation.

- ECOG Performance Status 0 to 2.

- Adequate bone marrow, liver, and renal function as assessed by the following:

- Hemoglobin ? 9.0 g/dl

- Absolute neutrophil count (ANC) ? 1,500/mm3

- Platelet count ? 100,000/mm3

- Total bilirubin ? 2.0 times the upper limit of normal

- Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ? 2.5 x
upper limit of normal (? 5x ULN for patients with liver involvement)

- International Normalized Ratio for Prothrombin Time (PT-INR) ? 1.5 and activated
partial prothrombin time (aPTT) within 5% of normal limits for patient NOT on

- Estimated Glomerular Filtration Rate (eGRF) > 50 ml/min .

- Male or female aged >18 years

- Patients must be able and willing to sign a written informed consent. A signed
informed consent must be appropriately obtained prior to any study specific

- Patients must be able to swallow and retain oral medication.

- Women of childbearing potential must have a negative serum pregnancy test performed
within 7 days prior to randomisation and must agree to use adequate contraception
prior to randomisation and for the duration of study participation.

Exclusion Criteria:

- Life expectancy less than 3 months.

- Substance abuse, medical, psychological, or social condition that may interfere with
the patient's participation in the study or evaluation of the study results.

- Severe cardiac or renal disease.

- Frank hypothyroidism.

- Hyponatraemia.

- Known or suspected allergy to lithium.

- Women who are pregnant or breast-feeding.

- Inability to comply with protocol and /or not willing or not available for follow-up

- Significant psychiatric or neurologic illness (prior known psych/cognitive/CNS
pathology eg CVA; known or prior brain metastases

- Current lithium therapy.
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