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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00886405
Recruitment Status : Unknown
Verified April 2009 by National Institute of Cancerología.
Recruitment status was:  Recruiting
First Posted : April 22, 2009
Last Update Posted : April 22, 2009
Information provided by:
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

Condition or disease Intervention/treatment Phase
Locally Advanced Non Small-Cell Lung Canger Drug: Transdermal nitroglycerin Phase 2

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 Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase II Study That Evaluates Concurrent Chemotherapy and Radiotherapy With Nitroglycerin in Patients With Locally Advanced Non-Small Cell Lung Cancer
Study Start Date : July 2006
Actual Primary Completion Date : April 2009
Estimated Study Completion Date : January 2010

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: Nytroglicerin Drug: Transdermal nitroglycerin
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 Measures :
  1. Time to progression, over-all survival [ Time Frame: 5 years ]

Secondary Outcome Measures :
  1. 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 ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00886405

Contact: Oscar A Rodriguez, MD (0155)56280400 ext 832

National Institute of Cancerología Recruiting
Mexico city, Distrito federal, Mexico
Principal Investigator: Oscar A Rodriguez, MD         
Sponsors and Collaborators
National Institute of Cancerología
Principal Investigator: Oscar A Rodriguez, MD National Counsil of Science and Technology

Responsible Party: Oscar Arrieta Rodríguez, CONACYT Identifier: NCT00886405     History of Changes
Other Study ID Numbers: CB332/08
First Posted: April 22, 2009    Key Record Dates
Last Update Posted: April 22, 2009
Last Verified: April 2009

Keywords provided by National Institute of Cancerología:
Locally advanced non small-cell lung cancer
Vascular endothelial growth factor
Hypoxia Inducible Factor
Clinical stage IIIA and/or IIIB (without pleural effusion)

Additional relevant MeSH terms:
Lung Neoplasms
Carcinoma, Non-Small-Cell Lung
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Lung Diseases
Respiratory Tract Diseases
Carcinoma, Bronchogenic
Bronchial Neoplasms
Vasodilator Agents