Status:
UNKNOWN
Valproic Acid With Chemoradiotherapy for Non-Small-Cell Lung Cancer
Lead Sponsor:
Soroka University Medical Center
Conditions:
Locally Advanced Inoperable Non-small-lung Cancer
Eligibility:
All Genders
18-75 years
Phase:
PHASE1
PHASE2
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 inop...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
February 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
February 1 2015
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT01203735
Start Date
February 1 2011
End Date
February 1 2015
Last Update
March 29 2011
Active Locations (1)
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1
Soroka University Medical Center
Beersheba, Israel, 84101