NCT04193007: BRATR

The Role of Brain Radiotherapy in Patients With Asymptomatic Brain Metastasis in the Era of Targeted Therapy for NSCLC

Status unknown Phase 2 Last updated 10 December 2019

What this trial tests

Phase 2 trial testing molecular targeted therapies in Non Small Cell Lung Cancer in 100 participants. Status unknown.

Timeline

1 December 2019

Primary endpoint
30 December 2021

1 June 2022

Quick facts

Lead sponsor	Second Affiliated Hospital of Nanchang University
Phase	Phase 2
Status	Status unknown
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	treatment
Enrollment	100
Start date	1 December 2019
Primary completion	30 December 2021
Estimated completion	1 June 2022
Sites	1 location across China

Drugs / interventions tested

• molecular targeted therapies — full drug profile →
• Brain Radiotherapy

Conditions studied

• Non Small Cell Lung Cancer — all drugs for Non Small Cell Lung Cancer →
• Brain Metastases — all drugs for Brain Metastases →

Sponsor

Second Affiliated Hospital of Nanchang University

Who can join

Adults 18 to 80, any sex, with Non Small Cell Lung Cancer or Brain Metastases. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

Brain metastasis is the most common neurological complication in tumor patients, and lung cancer is the most common tumor with brain metastasis. The prognosis of patients with non-small cell lung cancer with brain metastasis is poor. If not treated, the median survival time was about 1 month, the median survival time for steroid therapy was about 2 to 3 months, and the median survival time for patients receiving whole brain radiotherapy was about 3 to 6 months. Studies have shown that the incidence of brain metastasis is not only related to tumor size, N stage and tumor cell type, but also more likely to occur in NSCLC patients with sensitive gene mutation. With the rapid development of NSCLC molecular targeted therapy and precise radiotherapy, the new main therapeutic methods for NSCLC brain metastasis in recent years include stereotactic radiotherapy for (SRT),. Based on intensity modulated technique, simultaneous modulated accelerated radiation therapy for Brain(SMART-Brain) and molecular targeted therapy were carried out. However, at present, the best treatment choice for NSCLC brain metastasis, especially for asymptomatic brain metastasis patients, is still controversial. The choice and combined application mode of individualized treatment for different patients is still a problem to be explored. Based on the synergistic effect of radiotherapy and molecular targeted therapy on the basis of cell and molecule, The purpose of this study was to prospectively compare the efficacy of radiotherapy combined with targeted therapy and targeted therapy alone in patients with asymptomatic NSCLC brain metastasis with gene sensitive mutations, and subgroup analysis of different molecular targets and mutation sites. It is expected that this study will provide a basis for optimizing the curative effect of patients with NSCLC brain metastasis.

Publications & conference data

3 peer-reviewed publications reference this trial (live from Europe PMC):

1. Modern Radiation Therapy for the Management of Brain Metastases From Non-Small Cell Lung Cancer: Current Approaches and Future Directions.
   Mantovani C, Gastino A, Cerrato M, Badellino S, et al · · 2021 · cited 37× · PMID 34796118 · DOI 10.3389/fonc.2021.772789
2. Challenges and Novel Opportunities of Radiation Therapy for Brain Metastases in Non-Small Cell Lung Cancer.
   Jablonska PA, Bosch-Barrera J, Serrano D, Valiente M, et al · · 2021 · cited 19× · PMID 33946751 · DOI 10.3390/cancers13092141
3. Central nervous system metastases and oligoprogression during treatment with tyrosine kinase inhibitors in oncogene-addicted non-small cell lung cancer: how to treat and when?
   Schoenmaekers JJAO, Paats MS, Dingemans AC, Hendriks LEL. · · 2020 · cited 14× · PMID 33489821 · DOI 10.21037/tlcr-20-459