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Nitroglycerin Plus Intracranial Radiotherapy for Brain Metastases in NSCLC Patients

NCT04338867 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 96

Last updated 2020-04-22

No results posted yet for this study

Summary

Background: Whole-brain radiotherapy (WBRT) is the standard treatment for multiple brain metastases (BM), in NSCLC patients who are not candidates for treatment with stereotactic radiation body therapy. Hypoxia has been associated with chemo-radioresistance secondary to Vascular Endothelial Growth Factor Receptor (VEGFR) induced by Hypoxia Induced Factor (HIF). Nitroglycerin (NTG) can reduce HIF-1 alfa in tissues, and this may have anti-angiogenic, pro-apoptotic and anti-efflux effects. In this phase II study, we evaluated the effect of transdermal nitroglycerin (TN) on intracranial progression-free survival (ICPFS), objective response rate (ORR) and overall survival (OS) of NSCLC patients with BM.

Material and methods: We performed an open-label, phase II clinical trial among ninety-six histologically confirmed NSCLC patients with BM. Patients were randomized 1:1 to receive NTG plus WBRT or WBRT alone. ORR and ICPFS were evaluated by MRI by two independent, blinded radio-oncologists.

Conditions

  • Phase II Clinical Trial
  • Ninety-six Histologically Confirmed NSCLC Patients With BM
  • Randomized 1:1 to Received TN Plus WBR or Only WBR
  • ICPFS Evaluated by Two Blinded and Independent Radio-oncologist With MRI

Interventions

RADIATION

Whole-brain radiotherapy

Patients were randomized 1:1 and allocated to either the control arm who received whole-brain radiotherapy (WBRT) or the experimental arm who received WBRT and the addition 36 mg of transdermal nitroglycerin (TN)

Sponsors & Collaborators

  • Instituto Nacional de Cancerologia de Mexico

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
90 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-03-01
Primary Completion
2020-03-01
Completion
2020-03-01

Countries

  • Mexico

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04338867 on ClinicalTrials.gov