Back to resultsConcurrent Chemotherapy and Radiotherapy With Nitroglycerin in Patients With Locally Advanced Non-Small Cell Lung Cancer
Primary Purpose
Locally Advanced Non Small-Cell Lung Canger
Status
Unknown status
Phase
Phase 2
Locations
Mexico
Study Type
Interventional
Intervention
Transdermal nitroglycerin
Sponsored by
About this trial
This is an interventional treatment trial for Locally Advanced Non Small-Cell Lung Canger focused on measuring Nitroglycerin, Locally advanced non small-cell lung cancer, Vascular endothelial growth factor, Hypoxia Inducible Factor, Clinical stage IIIA and/or IIIB (without pleural effusion)
Eligibility Criteria
Inclusion Criteria:
- Histopathologic diagnosis of non small-cell lung cancer
- Clinical stage IIIA and/or IIIB without pleural effusion
- ECOG functional status 0 or 1
- No renal function alteration (GFR >50%)
- No hepatic function alteration (ALT and AST less than 2 times its normal value)
- Leucocytes more than 2,000/mcl
- Hemoglobin more than 10mg/dL
- Platelets more than 100,000/mcl
Exclusion Criteria:
- Ischemic heart disease
- Abnormal electrocardiogram
Sites / Locations
- National Institute of CancerologíaRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Nytroglicerin
Arm Description
Outcomes
Primary Outcome Measures
Time to progression, over-all survival
Secondary Outcome Measures
Levels of oxidative stress through lipid peroxidation and quantification of VEGF Toxicity from treatment with chemotherapy and concurrent chemo-radiotherapy combined with transdermal nitroglycerin
Full Information
NCT ID
NCT00886405
First Posted
April 21, 2009
Last Updated
April 21, 2009
Sponsor
National Institute of Cancerología
1. Study Identification
Unique Protocol Identification Number
NCT00886405
Brief Title
Concurrent Chemotherapy and Radiotherapy With Nitroglycerin in Patients With Locally Advanced Non-Small Cell Lung Cancer
Official Title
Phase II Study That Evaluates Concurrent Chemotherapy and Radiotherapy With Nitroglycerin in Patients With Locally Advanced Non-Small Cell Lung Cancer
Study Type
Interventional
2. Study Status
Record Verification Date
April 2009
Overall Recruitment Status
Unknown status
Study Start Date
July 2006 (undefined)
Primary Completion Date
April 2009 (Actual)
Study Completion Date
January 2010 (Anticipated)
3. Sponsor/Collaborators
Name of the Sponsor
National Institute of Cancerología
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
Nitroglycerin will increase the effectiveness of treatment with induction chemotherapy and concurrent chemo-radiotherapy by reducing chemo-radio resistance through an increased oxygen pressure in tumoral tissue. The combination treatment of nitroglycerin and chemotherapy will result in longer disease-free and over-all survival in patients with locally advanced NSCLC
Detailed Description
Nitroglycerin decreases hypoxia-induced resistance to antitumor drugs due to inhibition of Hypoxia Inducible Factor alfa (HIF-1α), it increases oxygen pressure in tumoral tissue by augmenting tumor blood flow, increases apoptosis, activation of p53, and induces cellular growth inhibition. Randomized studies showed that the addition of transdermal nitroglycerin to non small cell lung cancer (NSCLC) patients with metastasis treated with vinorelbine and cisplatin achieved a significantly better global response to treatment than conventional treatment
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Locally Advanced Non Small-Cell Lung Canger
Keywords
Nitroglycerin, Locally advanced non small-cell lung cancer, Vascular endothelial growth factor, Hypoxia Inducible Factor, Clinical stage IIIA and/or IIIB (without pleural effusion)
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
40 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Nytroglicerin
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
Transdermal nitroglycerin
Intervention Description
Transdermal nitroglycerin (25mg/day) during 5 days (2 days before and 3 days after chemotherapy) at the beginning of each chemotherapy cycle for a total of 4 cycles
Primary Outcome Measure Information:
Title
Time to progression, over-all survival
Time Frame
5 years
Secondary Outcome Measure Information:
Title
Levels of oxidative stress through lipid peroxidation and quantification of VEGF Toxicity from treatment with chemotherapy and concurrent chemo-radiotherapy combined with transdermal nitroglycerin
Time Frame
5 years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Histopathologic diagnosis of non small-cell lung cancer
Clinical stage IIIA and/or IIIB without pleural effusion
ECOG functional status 0 or 1
No renal function alteration (GFR >50%)
No hepatic function alteration (ALT and AST less than 2 times its normal value)
Leucocytes more than 2,000/mcl
Hemoglobin more than 10mg/dL
Platelets more than 100,000/mcl
Exclusion Criteria:
Ischemic heart disease
Abnormal electrocardiogram
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Oscar A Rodriguez, MD
Phone
(0155)56280400
Ext
832
Email
ogar@servidor.unam.mx
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Oscar A Rodriguez, MD
Organizational Affiliation
National Counsil of Science and Technology
Official's Role
Principal Investigator
Facility Information:
Facility Name
National Institute of Cancerología
City
Mexico city
State/Province
Distrito federal
Country
Mexico
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Oscar A Rodriguez, MD
12. IPD Sharing Statement
Learn more about this trial
Concurrent Chemotherapy and Radiotherapy With Nitroglycerin in Patients With Locally Advanced Non-Small Cell Lung Cancer
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