Last updated 11 months ago

Nitroglycerin Plus Radiotherapy Versus Conventional Radiotherapy in Patients With Lung Cancer.

74 patients around the world
Available in Mexico
The prognosis of patients with central nervous system (CNS) metastases is poor. About 50% of patients with CPCNP and EGFR mutation have tumor activity in the central nervous system during the first 2 years of diagnosis. Treatment with total cranial radiation therapy (CRT) has shown to have a benefit in local response and patient survival. However, resistance factors such as intratumoral hypoxia decrease the response by CRT. Thus, the use of nitric oxide generators, such as nitroglycerin, has been shown to avoid radio resistance. A previous study conducted at our Institute showed that the addition of transdermal nitroglycerin (NTG) CRT increases intracranial response evaluated by objective radiological response in patients with NSCLC and the subgroup in which a greater benefit was seen was in patients with mutations in the EGFR gene. In this study we propose that the addition of transdermal nitroglycerin to patients with brain metastases and mutations in the EGFR gene receiving CRT will have an increase in intracranial objective response.
Instituto Nacional de Cancerologia de Mexico
1Research sites
74Patients around the world

This study is for people with

Lung cancer
Non-small cell lung carcinoma

Requirements for the patient

To 85 Years
All Gender

Medical requirements

Patients diagnosed with advanced non-small cell lung cancer (which includes de novo stage IIIB-IV, according to the 8th edition AJCC, or recurrent disease), documented by histology and/or cytology.
Presence of brain metastases, candidates for treatment with holocranial radiation therapy.
Documented EGFR sensitivity mutation.
Disease measurable by criteria: The Response Assessment in Neuro-Oncology Brain Metastases (RANO-BM).
18 years and up.
Functional status, by ECOG scale 0-2.
Life expectancy at least 12 weeks.
Not receive vasodilator treatment as calcium channel blockers.
Electrocardiogram.
Neutrophil count 1.5 x 103/mm3, platelet count >100 x (103/mm3).
Serum bilirubin should be 1.5 of the upper normal limit (ULN, upper normal limit).
AST and/or ALT 2 ULN (or 5 x ULN in patients with liver metastases).
Serum creatinine 1.5 (ULN), or creatinine clearance 60ml/min.
Ability to comply with study and follow-up procedures.
Informed written (signed) consent to participate in the study.
Have tumor tissue (paraffin blocks from diagnostic biopsy) obtained before systemic treatment.
Any unstable systemic disease (including active infection, grade 4 hypertension, unstable angina, congestive heart failure, ischemic heart disease, liver, kidney disease).
Patients with a history of allergy to glyceryl tinistate.
Any other malignant pathology within the previous 5 years (except for cervical carcinoma in situ or basal-cell skin cancer, treated appropriately).
Pregnant and/or breastfeeding women.
Meningeal carcinomatosis corroborated by cytopathological study.
Disposal Criteria:
Failure to follow protocol rules.
Loss of patient follow-up.
Patients who express their desire not to continue the study.
Patients with unacceptable toxicity

Sites

Instituto Nacional de Cancerología - Ciudad de México
Recruiting
Avenida San Fernando 22, México DF
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