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

NCT04193007 | Unknown Phase 2

• 1 other identifier: Y-Q201802-009
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Non Small Cell Lung Cancer; Brain Metastases

Keywords

Non Small Cell Lung Cancer; Brain Metastases

Outcome Measures

Primary Outcomes (2)

• Intracranial progression-free survival,iPFS-LM

  Time from BM diagnosis to the first documentation of intracranial lesion progression or death with documented intracranial progression

  Every 6 weeks up to 2 years

• Objective Response Rate,ORR

  ORR, proportion of patients with a best overall response of complete response or partial response (CR+PR)

  1 month after treatment

Secondary Outcomes (3)

• Progress Free Survival rate,PFS

  Every 6 weeks up to 2 years

• Median Survival Time,MST

  Every 6 weeks up to 2 years

• adverse events

  Every 6 weeks up to 2 years

Other Outcomes (1)

• Overall Survival rate, OS

  Every 6 weeks up to 2 years, and then every 3 months up to 5 years

Study Arms (2)

molecular targeted therapy group

EXPERIMENTAL

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)

Drug: molecular targeted therapies

Brain Radiotherapy and molecular targeted therapy group

EXPERIMENTAL

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)

Drug: molecular targeted therapies; Radiation: Brain Radiotherapy

Interventions

molecular targeted therapies DRUG

if EGFR mutation is positive, (gefitinib, ecotinib, erlotinib）or ALK/ROS-1 positive（Crizotinib）

Also known as: Targeted Therapy, Molecular, Therapy, Molecular Targeted, Targeted Molecular Therapies

Brain Radiotherapy and molecular targeted therapy group; molecular targeted therapy group

Brain Radiotherapy RADIATION

SRS 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

Also known as: Stereotactic radiotherapy,SRS, simultaneous modulated accelerated radiation therapy for Brain,SMART-Brain

Brain Radiotherapy and molecular targeted therapy group

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Second Affiliated Hospital of Nanchang University: lead
• Nanchang University: collaborator

Study Sites (1)

The Second Afiliated Hospital of Nanchang University

Nanchang, Jiangxi, 330006, China

Location

Related Publications (17)

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MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung; Brain Neoplasms

Interventions

Molecular Targeted Therapy

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases; Central Nervous System Neoplasms; Nervous System Neoplasms; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Drug Therapy; Therapeutics

Study Officials

• Liu Anwen, Phd

  Second Affiliated Hospital of Nanchang University

  STUDY DIRECTOR

Central Study Contacts

Liu Anwen, Phd

CONTACT

+8613767120022; awliu666@163.com

Cai Jing, Phd

CONTACT

+8615270905381; cjdl879@163.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Parallel Assignment

Study Record Dates

• First Submitted: November 13, 2019
• First Posted: December 10, 2019
• Study Start: December 1, 2019
• Primary Completion: December 30, 2021
• Study Completion: June 1, 2022
• Last Updated: December 10, 2019

Record last verified: 2019-11

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)