Valproic Acid in Combination With Concurrent Chemoradiotherapy Using Vinorelbine and Cisplatin for Inoperable Locally Advanced Non-Small-Cell Lung Cancer
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