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 @ 3:25 AM
Ignite Modification Date:
2025-12-25 @ 3:25 AM
NCT ID:
NCT00664105
Eligibility Criteria:
Inclusion Criteria:
* Patients must voluntarily sign and date an informed consent before the initiation of any study procedures
* Patients must have non-metastatic, inoperable, Stage IIIA or IIIB histologically or cytologically documented NSCLC without evidence of malignant pleural effusion
* Patients must not have received any prior systemic chemotherapy, thoracic radiotherapy or surgical resection for treatment of NSCLC
* Patients must have at least one site of unidirectionally measurable disease
* Patients must be ≥ 3 weeks from a formal exploratory thoracotomy
* Patients must have a Radiation Oncology and Medical Oncology consult and approval prior to study entry
* Patients must be ≥ 18 years of age
* Women of childbearing potential must have a negative baseline serum pregnancy within 7 days prior to Week 1, Day 1 and must not be breast feeding.
* Women of childbearing potential and men with a sexual partner of child bearing potential must use an effective method of contraception beginning prior to study entry, for the duration of the study participation and for a minimum of 3 months after the last dose of chemotherapy.
* Patients must have adequate hepatic, renal, lung and bone marrow function as defined below:
* Absolute neutrophil count (ANC) \> 1,500/mm3
* Hemoglobin \> 9.0 gm/dL
* Creatinine \< 1.5
* Platelets \> 100,000/mm3
* Total bilirubin within normal limits (WNL)
* AST or ALT and Alkaline Phosphatase must be within the range allowing for eligibility, as per chart on page 10 of the protocol.
* Calculated CrCl \> 50 ml/min (via Cockroft-Gault formula).
* Forced expiratory volume in 1 second (FEV 1) \> 800 ml
Exclusion Criteria:
* Known hypersensitivity to drugs formulated with polysorbate 80
* Peripheral neuropathy Grade ≥ 2.
* Wet stage IIIB (documented malignant pleural effusion) or stage IV NSCLC
* Previous chemotherapy or radiation therapy
* Any concomitant malignancy, brain metastasis or uncontrolled, clinically significant medical or psychiatric disorder
* Pregnant or nursing women
* A greater than or equal to 10% weight loss over the past 3 months
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT00664105
Study Brief:
Protocol Section:
NCT00664105