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 @ 12:21 AM
Ignite Modification Date:
2025-12-25 @ 12:21 AM
NCT ID:
NCT00063258
Eligibility Criteria:
Inclusion Criteria:
1. Must have signed consent for LAB03-0383
2. Pathologic documentation of NSCLC
3. Stage IIIA and IIIB (T4 satellite nodules or invasion into T4 structures but no malignant effusion) with all patients requiring mediastinoscopy positive N2, potentially resectable disease. N3 disease is excluded.
4. Measurable disease
5. Zubrod performance status of 0 or 1
6. Calculated post-resectional FEV1 of \> 40%
7. WBC\>4000/l, ANC\>1500/l, platelets \> 100,000/l
8. Serum creatinine \< 1.5 ULN or calculated creatinine \> 50 cc/min
9. Total serum bilirubin \<1.5 x ULN or SGPT or SGOT \< 2 X ULN
10. The following must be completed within 28 days of registration: CT scan of the chest and upper abdomen to include the adrenals. Mediastinoscopy to document ipsilateral nodal involvement and exclude N3 disease Blood tests, and pulmonary function tests The following must be completed within 2 months of registration: Pet scan If a CT PET is done more than 28 days, only the CT needs to be repeated and a bone scan to rule out bone metastases
Exclusion Criteria:
1. No prior chemotherapy or radiation for NSCLC
2. No prior malignancy is allowed except for adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer, or other cancer from which the patient has been disease-free for at least five years. If patient is suspected or known to have basal or squamous skin cancer, this maybe treated after induction chemotherapy is completed at the time of thoracotomy.
3. No post-obstructive pneumonia or other serious infection or other serious underlying medical condition that would impair ability of patient to receive protocol treatment, including prior allergic reactions to drugs containing cremophor.
4. Pregnant or nursing women may not participate
Healthy Volunteers:
False
Sex:
ALL
Study:
NCT00063258
Study Brief:
Protocol Section:
NCT00063258