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 @ 10:20 PM
Ignite Modification Date:
2025-12-24 @ 10:20 PM
NCT ID:
NCT01203735
Eligibility Criteria:
Inclusion Criteria:
1. Age \> 18 years.
2. Newly-diagnosed, histologically or cytologically confirmed NSCLC.
3. Inoperable stage IIIA-B disease
4. KPS \> 60
5. FEV1 \>1.2L
6. No previous RT to chest
7. No serious comorbid condition
8. No treatment with biological response modifiers or cytotoxic agents within four weeks prior to study entry
9. No participation in clinical trial using any investigational drug or device within four weeks prior to study entry
10. No serious complication of malignant condition
11. No previous or concurrent malignancy at other sites except cone biopsied in situ carcinoma of the uterine cervix and adequately treated basal cell or squamous cell carcinoma of the skin
12. Adequate organ function as evidenced by the following peripheral blood counts or serum chemistries at study entry:
Hemoglobin \> 9.0 Gm/dL WBC count \> 4.0x109/L Neutrophile count \> 1.5 cells x 109/L, Version 1, May 12, 2010 Platelet count \> 100 x 109/L, Creatinine \< 1.5 mg/dL Total bilirubin \< upper limit of normal (ULN) AST/SGOT \< ULN Calcium \< ULN
13. Ability to sign informed consent
14. Ability to attend follow-up visits
Exclusion Criteria:
1. Operable disease
2. Metastases to contra-lateral mediastinal lymph nodes
3. Distant metastases
4. KPS \< 60
5. FEV1 \< 1.2L
6. Previous RT to chest
7. Treatment with biological response modifiers or cytotoxic agents within four weeks prior to study entry
8. Participation in clinical trial using any investigational drug or device within four weeks prior to study entry
9. Major surgical procedure within two weeks prior to study entry
10. Serious comorbid condition, inclusive but not limited to myocardial infarction within previous six months, uncontrolled cardiac arrhythmias, uncontrolled angina pectoris, active infection including acute hepatitis
11. Serious complication of malignant condition
12. Previous or concurrent malignancy
13. Inadequate organ function as evidenced by the following peripheral blood counts or serum chemistries at study entry:
Hemoglobin \< 9.0 Gm/dL WBC count \< 4.0x109/L Neutrophile count \< 1.5 cells x 109/L, Platelet count \< 100 x 109/L, Creatinine \> 1.5 mg/dL Total bilirubin \> ULN (upper limit of normal) AST/SGOT \> ULN Version 1, May 12, 2010 Calcium \> ULN
14. Inability to sign informed consent
15. Psychological, familial, sociological or geographical conditions which do not permit regular medical follow-up and compliance with the protocol
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
75 Years
Study:
NCT01203735
Study Brief:
Protocol Section:
NCT01203735