Valproic Acid With Chemoradiotherapy for Non-Small-Cell Lung Cancer

Study Overview
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Brief Summary
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This is non-randomized phase 2 study to evaluate toxicity and efficacy of VA with concurrent chemoradiotherapy (CCRT) containing weekly vinorelbine and cisplatin in patients with locally advanced inoperable non-small-cell lung cancer (NSCLC).All patients will be planned for three-dimensional conformal RT (3-DCRT). Concurrent weekly vinorelbine and cisplatin and oral valproic acid (VA)will be started at the first day of RT. Follow up will be conducted every 3 months after completion of the study treatment. Toxicity will be assessed using CTCAE, based on clinical examination and laboratory tests during the study treatment and at follow up visits. Response to treatment will be evaluated using RECIST criteria. Overall and progression free survival (OS and PFS) will be estimated using the Kaplan-Meier method.

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

Conditions
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Locally Advanced Inoperable Non-small-lung Cancer

Intervention / Treatment
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* Drug: Valproic acid


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Valproic acid, Chemoradiotherapy<br> | Drug: Valproic acid<br>* 800mg per day for entire period of RT<br>* Other names: Sodium valproate;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Toxicity |  | 24 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Survival |  | 24 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Non-small-cell lung cancer, Valproic acid, Chemotherapy, Radiotherapy