Concurrent Chemotherapy and Radiotherapy With Nitroglycer... | NCT00886405

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

NCT00886405

Sponsor

National Institute of Cancerología

Status

Unknown status

Last Update Posted

Apr 22, 2009Estimated

Enrollment

40Estimated

Phase

Phase 2

Conditions

Locally Advanced Non Small-Cell Lung Canger

Interventions

Transdermal nitroglycerin

Countries

Mexico

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Apr 2009

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jul 2006

Primary Completion Date

Apr 2009Actual

Completion Date

Jan 2010Estimated

First Submitted Date

Apr 21, 2009

First Submission Date that Met QC Criteria

Apr 21, 2009

First Posted Date

Apr 22, 2009Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Apr 21, 2009

Last Update Posted Date

Apr 22, 2009Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

40Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Nytroglicerin	Experimental		Drug: Transdermal nitroglycerin

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Transdermal nitroglycerin	Drug	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

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Time to progression, over-all survival		5 years

Secondary Outcomes

Measure	Description	Time Frame
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

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Oscar A Rodriguez, MD	Contact	(0155)56280400	832	ogar@servidor.unam.mx

Overall Officials

Name	Affiliation	Role
Oscar A Rodriguez, MD	National Counsil of Science and Technology	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
National Institute of Cancerología	Recruiting	Mexico City	Mexico City		Mexico

ID	Type	Description	Link
INCAN/CC/162/08
CA.030/CB332/08