Actively Recruiting
Nitroglycerin Plus Radiotherapy Versus Conventional Radiotherapy in Patients With Lung Cancer.
Led by Instituto Nacional de Cancerologia de Mexico · Updated on 2026-04-09
74
Participants Needed
1
Research Sites
207 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
The goal of this interventional phase III clinical trial is to evaluate objective intracranial response rate (iORR) after a treatment with total cranial radiation therapy plus concomitant transdermal nitroglycerin (NTG) addition or total cranial radiation therapy only in patients with stage IV non-small cell lung cancer with brain metastases and EGFR mutation. The main questions it aims to answer are: Determine progression-free survival (PFS) to CNS and overall survival (OS). Evaluate and compare the quality of life (QoL) of patients during and after treatment. Evaluate the cognitive function of patients before, during and after treatment. Evaluate treatment-associated toxicity to grade adverse treatment events Evaluation of HIF1α, VEGF and ROS1 in peripheral blood before and after nitroglycerin treatment. All participants will have laboratory tests at the beginning and end of radiation therapy. Cranial MRI will be performed prior to treatment and 12 weeks after the end of treatment, then every 16 weeks until intracranial progression. Patients in the interventional group will be given 36 mg patches of transdermal nitroglycerin for 24 hours with a 12-hour rest interval during treatment with radiation therapy. The control group will only receive total cranial radiation therapy at the same doses and with the same schedule.
CONDITIONS
Official Title
Nitroglycerin Plus Radiotherapy Versus Conventional Radiotherapy in Patients With Lung Cancer.
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Diagnosed with advanced non-small cell lung cancer (stage IIIB-IV or recurrent) confirmed by histology or cytology
- Presence of brain metastases and candidate for total cranial radiation therapy
- Documented EGFR sensitivity mutation
- Disease measurable by RANO-BM criteria
- Age 18 years or older
- ECOG functional status 0 to 2
- Life expectancy of at least 12 weeks
- No use of vasodilator treatments like calcium channel blockers
- Normal electrocardiogram
- Neutrophil count at least 1.5 x 10^3/mm3 and platelet count above 100 x 10^3/mm3
- Serum bilirubin at or below 1.5 times the upper normal limit
- AST and/or ALT less than 2 times upper normal limit (or less than 5 times in patients with liver metastases)
- Serum creatinine at or below 1.5 times upper normal limit or creatinine clearance above 60 ml/min
- Ability to comply with study procedures and follow-up
- Signed informed consent to participate
- Availability of tumor tissue from diagnostic biopsy before systemic treatment
You will not qualify if you...
- Unstable systemic diseases such as active infection, grade 4 hypertension, unstable angina, congestive heart failure, ischemic heart disease, liver or kidney disease
- History of allergy to glyceryl trinitrate
- Any other malignant disease within the last 5 years (except cervical carcinoma in situ or basal-cell skin cancer properly treated)
- Pregnant or breastfeeding women
- Meningeal carcinomatosis confirmed by cytopathology
- Failure to follow protocol rules
- Loss of patient follow-up
- Patient's decision to withdraw from the study
- Unacceptable treatment toxicity
AI-Screening
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Trial Site Locations
Total: 1 location
1
Instituto Nacional de Cancerologia
Mexico City, Mexico City, Mexico, 14080
Actively Recruiting
Research Team
O
Oscar G Arrieta, M.D., M.Sc.
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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