Concurrent Chemotherapy and Radiotherapy With Nitroglycerin in Patients With Locally Advanced Non-Small Cell Lung Cancer

National Institute of Cancerología40 enrolled

Overview

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

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

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Locally Advanced Non Small-Cell Lung Canger

Interventions

Transdermal nitroglycerinDRUG

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

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

National Institute of Cancerología

Mexico City, Mexico City, Mexico

RECRUITING

Outcomes

Primary Outcomes

Time to progression, over-all survival

Time frame: 5 years

Secondary Outcomes

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

Central Contacts

Oscar A Rodriguez, MD

CONTACT

(0155)56280400 ogar@servidor.unam.mx

Data from ClinicalTrials.gov

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