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 @ 11:18 PM
Ignite Modification Date:
2025-12-24 @ 11:18 PM
NCT ID:
NCT00093756
Eligibility Criteria:
Inclusion Criteria:
* Histologically or cytologically confirmed non-small cell lung cancer (NSCLC)
* Locally advanced stage IIIA or IIIB disease that is considered unresectable
* No stage IV disease
* Requires radiotherapy
* Performance status (PS) - Eastern Cooperative Oncology Group (ECOG) 0-1
* At least 12 weeks
* Absolute neutrophil count ≥ 1,500/mm\^3
* Platelet count ≥ 100,000/mm\^3
* Bilirubin ≤ 1.5 times upper limit of normal (ULN)
* aspartate aminotransferase (AST) ≤ 3 times ULN
* Creatinine ≤ 1.5 times ULN
* No New York Heart Association class III or IV heart disease
* Forced expiratory volume (FEV) FEV\_1 ≥ 1 L OR 35% of predicted
* Weight loss \< 10% within the past 3 months
* Not pregnant or nursing
* Negative pregnancy test
* Fertile patients must use effective contraception
* No peripheral neuropathy ≥ grade 2
* No other severe underlying disease that would preclude study participation
* No uncontrolled infection
* No unhealed wound within the past 2 weeks
* No other malignancy within the past 5 years except adequately treated basal cell or squamous cell skin cancer, adequately treated noninvasive carcinomas (carcinoma in situ), or localized prostate cancer
* No concurrent prophylactic filgrastim (G-CSF) or sargramostim (GM-CSF)
* No prior systemic chemotherapy for NSCLC\*
* No prior radiotherapy to the chest
* More than 2 weeks since prior major surgery
Contraindications
* Any of the following:
* Pregnant wome
* Nursing women
* Men or women of childbearing potential or their sexual partners who are unwilling to employ adequate contraception (condoms, diaphragm, birth control pills, injections, intrauterine device \[IUD\], or abstinence, etc.) as this regimen may be harmful to a developing fetus or nursing child NOTE: This study involves an investigational agent whose genotoxic, mutagenic and teratogenic effects on the developing fetus and newborn are unknown.
* Any of the following prior therapies:
* Prior radiation therapy to the chest
* Prior systemic chemotherapy for NSCLC (phase II portion)
* New York Heart Association classification III or IV (see Appendix II).
* Any other severe underlying diseases which are, in the judgment of the investigator, inappropriate for entry into this study.
* uncontrolled infection.
* Major surgery or unhealed wound ≤ 2 weeks prior to registration.
* Prior history of malignancy ≤ 5 years, except for adequately treated basal cell or squamous cell skin cancer, adequately treated noninvasive carcinomas (carcinoma in situ), or localized prostate cancer.
* Peripheral neuropathy ≥grade 2
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT00093756
Study Brief:
Protocol Section:
NCT00093756