Know Cancer

or
forgot password

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


Phase 1/Phase 2
18 Years
75 Years
Open (Enrolling)
Both
Locally Advanced Inoperable Non-small-lung Cancer

Thank you

Trial Information

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


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

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Toxicity

Outcome Time Frame:

24 months

Safety Issue:

Yes

Principal Investigator

Konstantin Lavrenkov, MD, PhD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Soroka University Medical Center

Authority:

Israel: Ministry of Health

Study ID:

SOR507910CTIL

NCT ID:

NCT01203735

Start Date:

February 2011

Completion Date:

February 2015

Related Keywords:

  • Locally Advanced Inoperable Non-small-lung Cancer
  • Non-small-cell lung cancer
  • Valproic acid
  • Chemotherapy
  • Radiotherapy
  • Carcinoma, Non-Small-Cell Lung
  • Lung Neoplasms

Name

Location