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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04193007
Recruitment Status : Not yet recruiting
First Posted : December 10, 2019
Last Update Posted : December 10, 2019
Sponsor:
Collaborator:
Nanchang University
Information provided by (Responsible Party):
Second Affiliated Hospital of Nanchang University

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.

Condition or disease Intervention/treatment Phase
Non Small Cell Lung Cancer Brain Metastases Drug: molecular targeted therapies Radiation: Brain Radiotherapy Phase 2

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

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Randomized Phase II Trial of Brain Radiotherapy Combined With Targeted Therapy in Patients With Asymptomatic NSCLC Brain Metastasis With Gene Sensitive Mutation
Estimated Study Start Date : December 1, 2019
Estimated Primary Completion Date : December 30, 2021
Estimated Study Completion Date : June 1, 2022

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: 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)
Drug: molecular targeted therapies
if EGFR mutation is positive, (gefitinib, ecotinib, erlotinib)or ALK/ROS-1 positive(Crizotinib)
Other Names:
  • Targeted Therapy, Molecular
  • Therapy, Molecular Targeted
  • Targeted Molecular Therapies

Experimental: 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)
Drug: molecular targeted therapies
if EGFR mutation is positive, (gefitinib, ecotinib, erlotinib)or ALK/ROS-1 positive(Crizotinib)
Other Names:
  • Targeted Therapy, Molecular
  • Therapy, Molecular Targeted
  • Targeted Molecular Therapies

Radiation: Brain Radiotherapy
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
Other Names:
  • Stereotactic radiotherapy,SRS
  • simultaneous modulated accelerated radiation therapy for Brain,SMART-Brain




Primary Outcome Measures :
  1. Intracranial progression-free survival,iPFS-LM [ Time Frame: Every 6 weeks up to 2 years ]
    Time from BM diagnosis to the first documentation of intracranial lesion progression or death with documented intracranial progression

  2. Objective Response Rate,ORR [ Time Frame: 1 month after treatment ]
    ORR, proportion of patients with a best overall response of complete response or partial response (CR+PR)


Secondary Outcome Measures :
  1. Progress Free Survival rate,PFS [ Time Frame: Every 6 weeks up to 2 years ]
    The period from the start of treatment to the progression or death of a patient

  2. Median Survival Time,MST [ Time Frame: Every 6 weeks up to 2 years ]
    the cumulative survival rate is 0.5, the corresponding survival time means that only 50% of the individuals can live through this time.

  3. adverse events [ Time Frame: Every 6 weeks up to 2 years ]
    Number of patients with adverse events (AEs) as a measure of safety and tolerability


Other Outcome Measures:
  1. Overall Survival rate, OS [ Time Frame: Every 6 weeks up to 2 years, and then every 3 months up to 5 years ]
    time from the beginning of study to death due to any cause or last follow-up



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04193007


Contacts
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Contact: Liu Anwen, Phd +8613767120022 awliu666@163.com
Contact: Cai Jing, Phd +8615270905381 cjdl879@163.com

Locations
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China, Jiangxi
The Second Afiliated Hospital of Nanchang University
Nanchang, Jiangxi, China, 330006
Contact: Anwen Liu, MD    13767120022    awliu666@163.com   
Sponsors and Collaborators
Second Affiliated Hospital of Nanchang University
Nanchang University
Investigators
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Study Director: Liu Anwen, Phd Second Affiliated Hospital of Nanchang University

Publications of Results:

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Responsible Party: Second Affiliated Hospital of Nanchang University
ClinicalTrials.gov Identifier: NCT04193007    
Other Study ID Numbers: Y-Q201802-009
First Posted: December 10, 2019    Key Record Dates
Last Update Posted: December 10, 2019
Last Verified: November 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Second Affiliated Hospital of Nanchang University:
Non Small Cell Lung Cancer
Brain Metastases
Additional relevant MeSH terms:
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Neoplasm Metastasis
Neoplasms, Second Primary
Brain Neoplasms
Lung Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Bronchial Neoplasms
Central Nervous System Neoplasms
Nervous System Neoplasms
Central Nervous System Diseases
Carcinoma, Non-Small-Cell Lung
Lung Diseases
Respiratory Tract Diseases
Carcinoma, Bronchogenic
Neoplastic Processes
Pathologic Processes
Brain Diseases
Nervous System Diseases