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Trial Title:
Concurrent Chemotherapy and Radiotherapy With Nitroglycerin in Patients With Locally Advanced Non-Small Cell Lung Cancer
NCT ID:
NCT00886405
Condition:
Locally Advanced Non Small-Cell Lung Canger
Conditions: Official terms:
Lung Neoplasms
Carcinoma, Non-Small-Cell Lung
Nitroglycerin
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)
Study type:
Interventional
Study phase:
Phase 2
Overall status:
Unknown status
Study design:
Allocation:
Non-Randomized
Intervention model:
Single Group Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
Transdermal nitroglycerin
Description:
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
Arm group label:
Nytroglicerin
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
Criteria for eligibility:
Criteria:
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
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
National Institute of Cancerología
Address:
City:
Mexico city
Country:
Mexico
Status:
Recruiting
Investigator:
Last name:
Oscar A Rodriguez, MD
Email:
Principal Investigator
Start date:
July 2006
Completion date:
January 2010
Lead sponsor:
Agency:
National Institute of Cancerología
Agency class:
Other
Source:
National Institute of Cancerología
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT00886405
