Locally Advanced Inoperable Non-small-lung Cancer
Conditions
Keywords
Non-small-cell lung cancer, Valproic acid, Chemotherapy, Radiotherapy
Brief summary
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.
Interventions
DRUGValproic acid
800mg per day for entire period of RT
Sponsors
Soroka University Medical Center
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Toxicity | 24 months |
Secondary
| Measure | Time frame |
|---|---|
| Survival | 24 months |
Countries
Israel
Contacts
Primary ContactKonstantin Lavrenkov, MD, PhD
Outcome results
None listed