Locally Advanced Non Small-Cell Lung Canger
Conditions
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)
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
Interventions
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
Sponsors
National Institute of Cancerología
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Time to progression, over-all survival | 5 years |
Secondary
| Measure | Time frame |
|---|---|
| Levels of oxidative stress through lipid peroxidation and quantification of VEGF Toxicity from treatment with chemotherapy and concurrent chemo-radiotherapy combined with transdermal nitroglycerin | 5 years |
Countries
Mexico
Contacts
Primary ContactOscar A Rodriguez, MD
Outcome results
None listed