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

Launched by INSTITUTO NACIONAL DE CANCEROLOGIA DE MEXICO · Jan 26, 2024

Keywords

ClinConnect Summary

This clinical trial is investigating whether adding transdermal nitroglycerin (NTG) to standard cranial radiation therapy can improve treatment outcomes for patients with stage IV non-small cell lung cancer that has spread to the brain. The main goals are to see if this combination can help patients live longer without their cancer worsening, improve their overall survival, and enhance their quality of life during and after treatment. Researchers will also assess how well patients think and feel before, during, and after the treatment, along with monitoring for any side effects.

To participate, patients must be at least 18 years old, have advanced lung cancer with brain metastases, and have a specific genetic mutation (the EGFR mutation). They should also be able to undergo treatment safely and have a life expectancy of at least 12 weeks. Participants will receive either the nitroglycerin patches along with radiation or just the radiation therapy alone. Throughout the study, patients will undergo various tests, including MRIs and lab work, to track their health and treatment effects. This trial is currently looking for volunteers who meet the eligibility criteria.

Gender

ALL

Eligibility 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