NCT00886405

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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
40

participants targeted

Target at P25-P50 for phase_2

Timeline
Completed

Started Jul 2006

Typical duration for phase_2

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2006

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2009

Completed
20 days until next milestone

First Submitted

Initial submission to the registry

April 21, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

April 22, 2009

Completed
8 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2010

Completed
Last Updated

April 22, 2009

Status Verified

April 1, 2009

Enrollment Period

2.8 years

First QC Date

April 21, 2009

Last Update Submit

April 21, 2009

Conditions

Locally Advanced Non Small-Cell Lung Canger

Keywords

NitroglycerinLocally advanced non small-cell lung cancerVascular endothelial growth factorHypoxia Inducible FactorClinical stage IIIA and/or IIIB (without pleural effusion)

Outcome Measures

Primary Outcomes (1)

  • Time to progression, over-all survival

    5 years

Secondary Outcomes (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

    5 years

Study Arms (1)

Nytroglicerin

EXPERIMENTAL
Drug: Transdermal nitroglycerin

Interventions

Transdermal nitroglycerinDRUG

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

Nytroglicerin

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • Ischemic heart disease
  • Abnormal electrocardiogram

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

National Institute of Cancerología

Mexico City, Mexico City, Mexico

RECRUITING

Study Officials

  • Oscar A Rodriguez, MD

    National Counsil of Science and Technology

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Oscar A Rodriguez, MD

CONTACT

(0155)56280400ogar@servidor.unam.mx

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER GOV

Study Record Dates

First Submitted

April 21, 2009

First Posted

April 22, 2009

Study Start

July 1, 2006

Primary Completion

April 1, 2009

Study Completion

January 1, 2010

Last Updated

April 22, 2009

Record last verified: 2009-04

Locations

ME(1)