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 @ 10:12 PM
Ignite Modification Date:
2025-12-24 @ 10:12 PM
NCT ID:
NCT00280735
Eligibility Criteria:
DISEASE CHARACTERISTICS:
Inclusion criteria:
* Histologically confirmed non-small cell lung cancer
* Stage I-IIIA disease
* Must have undergone a complete resection
* Must begin adjuvant chemotherapy within 8 weeks of surgical resection
PATIENT CHARACTERISTICS:
* Eastern Cooperative Oncology Group (ECOG) performance status 0-1
* Absolute neutrophil count ≥ 1,500/mm\^3
* Hemoglobin ≥ 8.0 g/dL
* Platelet count ≥ 100,000/mm\^3
* Serum creatinine normal OR creatinine clearance ≥ 40 mL/min
* Bilirubin normal
* Alkaline phosphatase (AP), Aspartate aminotransferase (AST), and Alanine transaminase (ALT) must meet 1 of the following criteria:
* AP normal AND AST and ALT ≤ 5 times upper limit of normal (ULN)
* AP ≤ 2.5 times ULN AND AST and ALT ≤ 1.5 times ULN
* AP ≤ 5 times ULN AND AST and ALT normal
* Negative pregnancy test
* Fertile patients must use effective contraception during and for at least 3 months after study therapy
Exclusion criteria:
* Patients with a history of severe hypersensitivity to docetaxel or polysorbate 80 are excluded.
* Women who are currently or planning to breast feed.
* Those with peripheral neuropathy ≥ grade 2
PRIOR CONCURRENT THERAPY:
* 2-8 weeks since prior surgery and recovered
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
120 Years
Study:
NCT00280735
Study Brief:
Protocol Section:
NCT00280735