Nitroglycerin Plus Radiotherapy Versus Conventional Radiotherapy in Patients With Lung Cancer.
NCT06238882, Not applicable, Recruiting, Instituto Nacional de Cancerologia de Mexico
Trial 10
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
| Field | Value | Source |
|---|---|---|
| Title | Nitroglycerin Plus Radiotherapy Versus Conventional Radiotherapy in Patients With Lung Cancer. | ClinicalTrials.gov |
| NCT number | NCT06238882 | ClinicalTrials.gov |
| Status | Recruiting | ClinicalTrials.gov |
| Phases | Not applicable | ClinicalTrials.gov |
| Enrollment | 74 participants, estimated | ClinicalTrials.gov |
| Lead sponsor | Instituto Nacional de Cancerologia de Mexico | ClinicalTrials.gov |
| Conditions | Non-small Cell Lung Cancer, Brain Metastases, EGFR Gene Mutation | ClinicalTrials.gov |
| Interventions | Nitroglycerin | ClinicalTrials.gov |
| First posted | 2024-02-02 | ClinicalTrials.gov |
| Last updated | 2026-04-09 | ClinicalTrials.gov |
Registered outcomes 6
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description | Source |
|---|---|---|---|---|
| Primary | iORR | From date after radiation treatment until the first documented progression date, or last evaluable assessment in the absence of progression, or death from any cause, whichever comes first, to 12 weeks of follow up. | Objective intracranial response rate (iORR) in patients with lung cancer and brain metastases treated with total cranial radiation therapy plus concomitant transdermal nitroglycerin addition versus patients treated with total cranial radiation therapy only. | ClinicalTrials.gov |
| Secondary | iPFS | From date of treatment initiation until date of disease progression or worsening until 12 weeks, and every 16 weeks of follow up until progression. | Intracranial progression-free survival (iPFS) in patients with lung cancer and brain metastases treated with total cranial radiation therapy plus concomitant transdermal nitroglycerin addition versus patients treated with total cranial radiation therapy only. | ClinicalTrials.gov |
| Secondary | OS | Duration of patient survival from the date of treatment initiation until until 12 weeks, and every 16 weeks of follow up | Overall survival (OS) in patients with lung cancer and brain metastases treated with total cranial radiation therapy plus concomitant transdermal nitroglycerin addition versus patients treated with total cranial radiation therapy only. | ClinicalTrials.gov |
| Secondary | QoL | A day before, within, and a day after the date of treatment initiation until date of disease progression or worsening or 12 weeks, and every 16 weeks of follow up. | Quality of Life (QoL) measured by EORTC QLQ C30/LC13 in patients with lung cancer and brain metastases treated with total cranial radiation therapy plus concomitant transdermal nitroglycerin addition versus patients treated with total cranial radiation therapy only. The EORTC QLQ-C30 questionnaire consists of 30 questions with five functional scores (physical, role, cognitive, emotional and social); a global health status score three symptom scale score (fatigue, pain, nausea and vomiting); and six independent one-it. All scale and single-item scores can be linearly transformed to a score ranged from 0 to 100. A higher score of global health and functional subscriptions indicates better functioning. | ClinicalTrials.gov |
| Secondary | Cognitive function | A day before, within, and a day after the date of treatment initiation until date of disease progression or worsening or 12 weeks, and every 16 weeks of follow up. | Evaluate the cognitive function of patients with lung cancer and brain metastases treated with nitroglycerin vs radiation therapy alone before, during and after treatment using the Neuropsi Attention and Memory (NAM) instrument. NEUROPSI evaluates attention, memory, and learning functioning in Spanish speakers. Subtests are organized into summary scores that yield a General Attention and Memory Index Score, an Attention Index, Memory Index, and each of the subtests. Subtests evaluate Orientation, Attention and Concentration, Working Memory, Immediate Verbal Memory, Delayed Verbal Memory, Immediate Visual Memory, Delayed Verbal Memory, and Executive Functions. The Neuropsi Attention and Memory includes theoretical updates and new test scores indexes. It includes an adjustment of the norms of Total Attention and Executive Functions and Total Attention and Memory according to the modification of the tasks of digit detection and Stroop test. | ClinicalTrials.gov |
| Secondary | Treatment-related Toxicity | Thee date of day 1, 7 and 10 of therapy and the date of 12 weeks after treatment. | Treatment-related toxicity in patients with lung cancer and brain metastases treated with total cranial radiation therapy plus concomitant transdermal nitroglycerin addition versus patients treated with total cranial radiation therapy only using NCI Common Terminology Criteria for Adverse Events (CTCAE), version 5.0 to grading adverse events (AE). A grading (severity) scale is provided for each AE term. The CTCAE displays Grades 1 through 5: Grade 1 Mild; asymptomatic or mild symptoms; clinical or diagnostic observations only; intervention not indicated. Grade 2 Moderate; minimal, local or noninvasive intervention indicated; limiting age appropriate instrumental ADL\*. Grade 3 Severe or medically significant but not immediately life-threatening; hospitalization or prolongation of hospitalization indicated; disabling; limiting self care ADL\*\*. Grade 4 Life-threatening consequences; urgent intervention indicated. Grade 5 Death related to AE. | ClinicalTrials.gov |
Outcomes 0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as | Source |
|---|
Results by group 0
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units | Source |
|---|
Participant flow 0
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted | Source |
|---|
Adverse events 0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events | Source |
|---|
Adverse event totals 0
The totals the trial posted for each group.
| Total | Group | Affected | At risk | Source |
|---|
Papers 0
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as | Source |
|---|
Grants 0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
| Project | Title | Principal investigators | Organization | Funder | Fiscal years | Source |
|---|
Trial comparisons 0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|
Tests 1
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
| Test | Named as | Source |
|---|---|---|
| Stroop Color-Word Test | Secondary outcome | ConductCognition |
Source 5
| Field | Value | Source |
|---|---|---|
| Release | trials-2026-11-12-0.4.0 | ClinicalTrials.gov |
| Release manifest SHA-256 | 0f4a8d8c48aee2a7573ae0fa94ecbeab70c1adbe449bbc95c424bc7d3e97b9d4 | ClinicalTrials.gov |
| Registry capture | 2026-11-12 | ClinicalTrials.gov |
| Results copy, AACT | 2026-03-23 | ClinicalTrials.gov |
| NIH clinical studies file | 2026-11-13 | ClinicalTrials.gov |
Release trials-2026-11-12-0.4.0
ClinicalTrials.gov's posted results, through CTTI's AACT: ClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299 ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
ClinicalTrials.gov: none stated ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
NIH RePORTER's clinical studies and project files: Public domain (NIH RePORTER)