Know Cancer

or
forgot password

Phase II Study That Evaluates Concurrent Chemotherapy and Radiotherapy With Nitroglycerin in Patients With Locally Advanced Non-Small Cell Lung Cancer


Phase 2
18 Years
N/A
Open (Enrolling)
Both
Locally Advanced Non Small-Cell Lung Canger

Thank you

Trial Information

Phase II Study That Evaluates Concurrent Chemotherapy and Radiotherapy With Nitroglycerin in Patients With Locally Advanced Non-Small Cell Lung Cancer


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


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

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Time to progression, over-all survival

Outcome Time Frame:

5 years

Safety Issue:

No

Principal Investigator

Oscar A Rodriguez, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

National Counsil of Science and Technology

Authority:

Mexico: National Council of Science and Technology

Study ID:

CB332/08

NCT ID:

NCT00886405

Start Date:

July 2006

Completion Date:

January 2010

Related Keywords:

  • Locally Advanced Non Small-Cell Lung Canger
  • Nitroglycerin
  • Locally advanced non small-cell lung cancer
  • Vascular endothelial growth factor
  • Hypoxia Inducible Factor
  • Clinical stage IIIA and/or IIIB (without pleural effusion)
  • Carcinoma, Non-Small-Cell Lung
  • Lung Neoplasms

Name

Location