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

National Institute of Cancerología

Status and phase: Unknown; Phase 2

Conditions: Locally Advanced Non Small-Cell Lung Canger

Treatments: Drug: Transdermal nitroglycerin

Study type: Interventional

Funder types: Other

Identifiers

NCT00886405

CA.030/CB332/08

CB332/08

INCAN/CC/162/08

Details and patient eligibility

About

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

Full 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

Enrollment: 40 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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40 participants in 1 patient group

Nytroglicerin

Experimental group

Treatment:

Drug: Transdermal nitroglycerin