Clinical trial · Interventional
Nitroglycerin Plus Intracranial Radiotherapy for Brain Metastases in NSCLC Patients
Nitroglycerin Plus Whole Intracranial Radiotherapy for Brain Metastases in Non-small Cell Lung Cancer Patients: a Phase II Open Randomized Clinical Trial
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (4)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| ICPFS Evaluated by Two Blinded and Independent Radio-oncologist With MRI | — | UNRESOLVED | — |
| Ninety-six Histologically Confirmed NSCLC Patients With BM | — | UNRESOLVED | — |
| Phase II Clinical Trial | — | UNRESOLVED | — |
| Randomized 1:1 to Received TN Plus WBR or Only WBR | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Whole-brain radiotherapy | Radiation | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- Therapeutic arm
- description
- Patients who received WBRT and the addition 36 mg of transdermal nitroglycerin (TN) with the release of 10 mg in 24 hours, for 24 hours with a 12-hour rest interval (to avoid saturation of receptors)
- interventionNames
- Radiation: Whole-brain radiotherapy
- type
- ACTIVE_COMPARATOR
- label
- Control arm
- description
- Patients who received whole-brain radiotherapy (WBRT) (30 Gy in 10 fractions, in 10 days of treatment)
- interventionNames
- Radiation: Whole-brain radiotherapy
Primary outcomes (1)
- measure
- itroglycerin Plus Intracranial Radiotherapy for Brain Metastases in NSCLC Patients
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 90 Years
Show eligibility criteria text
Inclusion Criteria: * Patients with histologically confirmed NSCLC with documented BM (defined as the presence of one or more intra-axial enhancing lesions on gadolinium-enhanced brain magnetic resonance imaging (MRI) Exclusion Criteria: * Candidate patients who underwent radiosurgery or surgery resection
References
Publications (16)
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- BACKGROUNDAndrews DW, Scott CB, Sperduto PW, Flanders AE, Gaspar LE, Schell MC, Werner-Wasik M, Demas W, Ryu J, Bahary JP, Souhami L, Rotman M, Mehta MP, Curran WJ Jr. Whole brain radiation therapy with or without stereotactic radiosurgery boost for patients with one to three brain metastases: phase III results of the RTOG 9508 randomised trial. Lancet. 2004 May 22;363(9422):1665-72. doi: 10.1016/S0140-6736(04)16250-8. PMID 15158627
- BACKGROUNDHuber SM, Butz L, Stegen B, Klumpp D, Braun N, Ruth P, Eckert F. Ionizing radiation, ion transports, and radioresistance of cancer cells. Front Physiol. 2013 Aug 14;4:212. doi: 10.3389/fphys.2013.00212. eCollection 2013. PMID 23966948
- BACKGROUNDTian J, Luo Y, Xiang J, Tang J. Combined treatment for non-small cell lung cancer and breast cancer patients with brain metastases with whole brain radiotherapy and temozolomide: a systematic review and meta-analysis. J Neurooncol. 2017 Nov;135(2):217-227. doi: 10.1007/s11060-017-2572-z. Epub 2017 Jul 19. PMID 28726172
- BACKGROUNDRojas-Puentes LL, Gonzalez-Pinedo M, Crismatt A, Ortega-Gomez A, Gamboa-Vignolle C, Nunez-Gomez R, Dorantes-Gallareta Y, Arce-Salinas C, Arrieta O. Phase II randomized, double-blind, placebo-controlled study of whole-brain irradiation with concomitant chloroquine for brain metastases. Radiat Oncol. 2013 Sep 8;8:209. doi: 10.1186/1748-717X-8-209. PMID 24010771
- BACKGROUNDBerghoff AS, Preusser M. The inflammatory microenvironment in brain metastases: potential treatment target? Chin Clin Oncol. 2015 Jun;4(2):21. doi: 10.3978/j.issn.2304-3865.2015.06.03.