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

Phase 2

• Conditions: Locally Advanced Non Small-Cell Lung Canger
• Interventions: Drug: Transdermal nitroglycerin

• Registration Number: NCT00886405
• Lead Sponsor: National Institute of Cancerología

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

Study Timeline

• Study Start: 2006-07
• Status Verified: 2009-04
• Primary Completion: 2009-04
• Study First Submitted: 2009-04-21
• Study First Submitted QC: 2009-04-21
• Last Update Submitted: 2009-04-21
• Study First Posted: 2009-04-22
• Last Update Posted: 2009-04-22
• Study Completion: 2010-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 40

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Nytroglicerin	Transdermal nitroglycerin	-

Primary Outcome Measures

Name	Time	Method
Time to progression, over-all survival	5 years

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

National Institute of Cancerología; 🇲🇽 Mexico city, Distrito federal, Mexico