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 @ 11:50 PM
Ignite Modification Date:
2025-12-24 @ 11:50 PM
NCT ID:
NCT01624051
Eligibility Criteria:
Inclusion Criteria:
* Recommendation from treating oncologist to receive a cisplatin based chemotherapy regimen, specifically either cisplatin/vinorelbine or cisplatin/gemcitabine
* \> or = 18 years of age
* Histologically proven diagnosis of non-small cell lung cancer, Stage IIIB or IV
* Adequate renal function: creatinine \< 1.5 mg/dL or \< 132 µmol/L and creatinine clearance of \> 45 mL/min using the Cockcroft-Gault formula
* Adequate hepatic function: bilirubin \< 1.5 mg/dL or \< 25 µmol/L and AST and ALT \< 2 times upper limit of normal, unless there is evidence of liver metastases, in which case \< 5 times upper limit of normal
* Adequate hematological function: absolute neutrophil count (ANC) \> 1.5 x 109/L and platelets \> 100 x 109/L and hemoglobin \> 100 g/L
* Eastern Cooperative Oncology Group (ECOG) performance status of 0 - 2
* Negative serum pregnancy test for women of childbearing potential. Women and men of child bearing potential must use effective contraception defined as the simultaneous use of two reliable methods unless abstinence is the chosen method.
* Life expectancy of \> 4 months in the opinion of the treating oncologist
* Prior radiotherapy is allowed (unless \> 25% of bone marrow stores) if this radiation was \> 4 weeks before study entry and patient has fully recovered from toxicity of this treatment
* Willingness to comply with the study protocol
* Ability to give written informed consent with the understanding that it may be withdrawn at any time without prejudice
Exclusion Criteria:
* Pregnant or lactating women
* Brain metastases (a CT or MRI is not required to rule out brain metastases unless there is clinical suspicion)
* Previous or concurrent malignancies, excluding curatively treated in situ carcinoma of the cervix, in situ ductal breast cancer, non-melanoma skin cancer or low grade bladder cancer
* Patients who have had major surgery within three weeks of enrollment without a full recovery
* Prior treatment with any anticancer therapy
* Patients who have tested positive for HIV
* Any significant medical or psychiatric condition that, in the opinion of the investigator, will exclude the patient from the study for compliance or safety reasons
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT01624051
Study Brief:
Protocol Section:
NCT01624051