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

Plain-language summary

This study compares adding Nitroglycerin to radiotherapy with conventional radiotherapy in patients with advanced non-small cell lung cancer who have brain metastases. It enrolls patients aged 18 and older with a sensitizing EGFR mutation who are candidates for whole-brain radiation therapy. The study does not use a phase designation and is currently recruiting participants.

The summary above is a plain-language rendering of the official record. The original English title is shown for reference.

Trial details

Phase

Not Applicable

Status

Recruiting

Sponsor

Instituto Nacional de Cancerologia de Mexico

Intervention

Nitroglycerin

Start date

2/23/2023

Estimated completion

2/15/2027

Countries

Mexico

Related genes

Locations

• Mexico City, Mexico

Eligibility criteria

Criteria are reproduced from the ClinicalTrials.gov record in the original English. Only the trial team can determine eligibility.

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