search
Back to results

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

Primary Purpose

Locally Advanced Inoperable Non-small-lung Cancer

Status
Unknown status
Phase
Phase 1
Locations
Israel
Study Type
Interventional
Intervention
Valproic acid
Sponsored by
Soroka University Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Locally Advanced Inoperable Non-small-lung Cancer focused on measuring Non-small-cell lung cancer, Valproic acid, Chemotherapy, Radiotherapy

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Soroka University Medical CenterRecruiting

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

Valproic acid, Chemoradiotherapy

Arm Description

Outcomes

Primary Outcome Measures

Toxicity

Secondary Outcome Measures

Survival

Full Information

First Posted
September 15, 2010
Last Updated
March 27, 2011
Sponsor
Soroka University Medical Center
search

1. Study Identification

Unique Protocol Identification Number
NCT01203735
Brief Title
Valproic Acid With Chemoradiotherapy for Non-Small-Cell Lung Cancer
Official Title
Valproic Acid in Combination With Concurrent Chemoradiotherapy Using Vinorelbine and Cisplatin for Inoperable Locally Advanced Non-Small-Cell Lung Cancer
Study Type
Interventional

2. Study Status

Record Verification Date
September 2010
Overall Recruitment Status
Unknown status
Study Start Date
February 2011 (undefined)
Primary Completion Date
February 2013 (Anticipated)
Study Completion Date
February 2015 (Anticipated)

3. Sponsor/Collaborators

Name of the Sponsor
Soroka University Medical Center

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Locally Advanced Inoperable Non-small-lung Cancer
Keywords
Non-small-cell lung cancer, Valproic acid, Chemotherapy, Radiotherapy

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
20 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Valproic acid, Chemoradiotherapy
Arm Type
Other
Intervention Type
Drug
Intervention Name(s)
Valproic acid
Other Intervention Name(s)
Sodium valproate
Intervention Description
800mg per day for entire period of RT
Primary Outcome Measure Information:
Title
Toxicity
Time Frame
24 months
Secondary Outcome Measure Information:
Title
Survival
Time Frame
24 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Konstantin Lavrenkov, MD, PhD
Phone
972-86400537
Email
constant@bgu.ac.il
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Konstantin Lavrenkov, MD, PhD
Organizational Affiliation
Soroka University Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Soroka University Medical Center
City
Beer Sheva
ZIP/Postal Code
84101
Country
Israel
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Konstantin Lavrenkov, MD, PhD
Phone
+97286400537
Email
constant@bgu.ac.il
First Name & Middle Initial & Last Name & Degree
Julia Dudnik, MD
Phone
+97286400537
Email
juliad@clalit.org.il
First Name & Middle Initial & Last Name & Degree
Vladimir Gavrilov, MD, PhD
First Name & Middle Initial & Last Name & Degree
Julia Dudnik, MD
First Name & Middle Initial & Last Name & Degree
Kerenr Rouvinov, MD

12. IPD Sharing Statement

Learn more about this trial

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

We'll reach out to this number within 24 hrs