Valproic Acid With Chemoradiotherapy for Non-Small-Cell Lung Cancer
Locally Advanced Inoperable Non-small-lung Cancer
About this trial
This is an interventional treatment trial for Locally Advanced Inoperable Non-small-lung Cancer focused on measuring Non-small-cell lung cancer, Valproic acid, Chemotherapy, Radiotherapy
Eligibility Criteria
Inclusion Criteria:
- Age > 18 years.
- Newly-diagnosed, histologically or cytologically confirmed NSCLC.
- Inoperable stage IIIA-B disease
- KPS > 60
- FEV1 >1.2L
- No previous RT to chest
- No serious comorbid condition
- No treatment with biological response modifiers or cytotoxic agents within four weeks prior to study entry
- No participation in clinical trial using any investigational drug or device within four weeks prior to study entry
- No serious complication of malignant condition
- 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
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
- Ability to sign informed consent
- Ability to attend follow-up visits
Exclusion Criteria:
- Operable disease
- Metastases to contra-lateral mediastinal lymph nodes
- Distant metastases
- KPS < 60
- FEV1 < 1.2L
- Previous RT to chest
- Treatment with biological response modifiers or cytotoxic agents within four weeks prior to study entry
- Participation in clinical trial using any investigational drug or device within four weeks prior to study entry
- Major surgical procedure within two weeks prior to study entry
- 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
- Serious complication of malignant condition
- Previous or concurrent malignancy
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
- Inability to sign informed consent
- Psychological, familial, sociological or geographical conditions which do not permit regular medical follow-up and compliance with the protocol
Sites / Locations
- Soroka University Medical CenterRecruiting
Arms of the Study
Arm 1
Other
Valproic acid, Chemoradiotherapy