A Randomized Phase II Trial of Brain Radiotherapy Combined With Targeted Therapy in Patients With Asymptomatic NSCLC Brain Metastasis With Gene Sensitive Mutation

Second Affiliated Hospital of Nanchang University1 site in 1 country100 target enrollmentDecember 1, 2019

ConditionsNon Small Cell Lung Cancer Brain Metastases

Interventionsmolecular targeted therapies Brain Radiotherapy

Drugsmolecular targeted therapies

Overview

Phase: Phase 2
Intervention: molecular targeted therapies
Conditions: Non Small Cell Lung Cancer
Sponsor: Second Affiliated Hospital of Nanchang University
Enrollment: 100
Locations: 1
Primary Endpoint: Intracranial progression-free survival,iPFS-LM
Last Updated: 6 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief Summary

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.

Detailed Description

This is a randomized phase II clinical trial. The objective of the study is to assess efficacy and safety of brain radiotherapy combined with targeted therapy and simple targeted therapy in patients with asymptomatic NSCLC brain metastasis with gene sensitive mutation. Patients were randomized with equal allocation to Molecular targeted therapy alone or with brain radiotherapy. Study therapy continued until disease progression, unacceptable adverse event, or withdrawal of consent

Registry

clinicaltrials.gov

Start Date

December 1, 2019

End Date

June 1, 2022

Last Updated

6 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Second Affiliated Hospital of Nanchang University

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Histology confirmed that it was non-small cell lung cancer;
•EGFR, ALK or ROS1 gene detection showed sensitive gene mutation, and patients were willing to receive targeted therapy;
•brain MRI confirmed brain metastasis;
•asymptomatic or symptomatic brain metastasis could be controlled by glucocorticoid;
•PS score 0-1;
•no brain radiotherapy or targeted therapy before entering the group;
•there was no history of malignant tumor and no serious medical diseases;
•Laboratory examination: White blood cell count ≥ 4 \*10\^9/L, neutrophil count ≥ 2.0 \*10\^9, platelet count ≥ 100 \*10\^9, hemoglobin ≥ 10 g / L, liver and kidney function and ECG were normal;
•the pregnancy test was negative within 3 days before entering the group, and agreed to use medically effective contraceptives during the experiment;
•sign informed consent form.

Exclusion Criteria

•Small cell lung cancer was confirmed by pathology;
•other malignant tumors (unless PFS ≥ 3 years, except non-black skin cancer);
•were treated with brain radiotherapy or targeted therapy before;
•those with other potentially serious diseases (congestive heart failure, transmural myocardial infarction, admission with severe acute bacterial or fungal infection, COPD or other respiratory diseases that affect treatment, etc.), Taking into account that the study may exacerbate or fail to control the disease;
•severe immunosuppressive diseases, such as AIDS;
•pregnant women, lactating women or women of childbearing age who do not agree with the use of effective contraception in the trial;
•Intracranial metastasis with obvious symptoms or symptoms that can not be relieved by glucocorticoid alone

Arms & Interventions

molecular targeted therapy group

Molecular targeted therapy(according to the results of gene detection, targeted drugs were selected, such as EGFR mutation using the first generation of EGFR-TKI,ALK or ROS1 mutation using the first generation of ALK inhibitors)

Intervention: molecular targeted therapies

Brain Radiotherapy and molecular targeted therapy group

Brain Radiotherapy (stereotactic radiotherapy was used for 1-3 intracranial lesions, and simultaneous modulated accelerated radiation therapy for Brain(SMART-Brain )was used for more than 3 intracranial lesions);Molecular targeted therapy(according to the results of gene detection, targeted drugs were selected, such as EGFR mutation using the first generation of EGFR-TKI,ALK or ROS1 mutation using the first generation of ALK inhibitors)

Intervention: molecular targeted therapies