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

Study Purpose

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.

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

 No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

 Interventional
Eligible Ages 18 Years - 85 Years
Gender All
More Inclusion & Exclusion Criteria

Inclusion Criteria:

  • - 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.

Exclusion Criteria:

  • - 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

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

 NCT06238882
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

 N/A
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

 Instituto Nacional de Cancerologia de Mexico
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

 Oscar G Arrieta, M.D., M.Sc.
Principal Investigator Affiliation Instituto Nacional de Cancerologia de Mexico
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

 Other
Overall Status Recruiting
Countries Mexico
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

 Non-small Cell Lung Cancer, Brain Metastases, EGFR Gene Mutation
Additional Details

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.

Arms & Interventions

Arms

Experimental: Intervention

Patients will be given patches of nitroglycerin during treatment with radiation therapy (30 Gy in 10 fractions, i.e. 10 days of treatment).

No Intervention: Control

Patients will be given a conventional treatment with radiation therapy (30 Gy in 10 fractions, i.e. 10 days of treatment).

Interventions

Combination Product: - Nitroglycerin

Patients in the intervention group will receive four 8mg-patches (36 mg final dose) of transdermal nitroglycerin with 10 mg release in 24 hours, for 24 hours with 12-hour rest intervals (to avoid receptor saturation) during treatment with radiation therapy (30 Gy in 10 fractions, or 10 days of treatment).

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

International Sites

Instituto Nacional de Cancerologia, Mexico City, Mexico

Status

Recruiting

Address

Instituto Nacional de Cancerologia

Mexico City, , 14080

Site Contact

Oscar G Arrieta, M.D., M.Sc.

[email protected]

+525556280400 #44001

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