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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Valproic acid, Chemoradiotherapy | Other |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Valproic acid | Drug | 800mg per day for entire period of RT |
|
| Measure | Description | Time Frame |
|---|---|---|
| Toxicity | 24 months |
| Measure | Description | Time Frame |
|---|---|---|
| Survival | 24 months |
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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
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Konstantin Lavrenkov, MD, PhD | Contact | 972-86400537 | constant@bgu.ac.il |
| Name | Affiliation | Role |
|---|---|---|
| Konstantin Lavrenkov, MD, PhD | Soroka University Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Soroka University Medical Center | Recruiting | Beersheba | 84101 | Israel |
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| ID | Term |
|---|---|
| D002289 | Carcinoma, Non-Small-Cell Lung |
| ID | Term |
|---|---|
| D002283 | Carcinoma, Bronchogenic |
| D001984 | Bronchial Neoplasms |
| D008175 | Lung Neoplasms |
| D012142 | Respiratory Tract Neoplasms |
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| ID | Term |
|---|---|
| D014635 | Valproic Acid |
| ID | Term |
|---|---|
| D010421 | Pentanoic Acids |
| D014631 | Valerates |
| D000144 | Acids, Acyclic |
| D002264 | Carboxylic Acids |
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| D013899 |
| Thoracic Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D009930 |
| Organic Chemicals |
| D005232 | Fatty Acids, Volatile |
| D005227 | Fatty Acids |
| D008055 | Lipids |