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MR-Linac Guided Adaptive FSRT for Brain Metastases From Non-small Cell Lung Cancer

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ClinicalTrials.gov Identifier: NCT04946019
Recruitment Status : Recruiting
First Posted : June 30, 2021
Last Update Posted : June 30, 2021
Sponsor:
Information provided by (Responsible Party):
Hui Liu, Sun Yat-sen University

Brief Summary:
This Phase II study is to determine the efficacy and safety of MR-Linac Guided Adaptive fractionated stereotactic radiotherapy (FSRT) in patients with brain metastases in non-small cell lung cancer.

Condition or disease Intervention/treatment Phase
Non-small Cell Lung Cancer Combination Product: Unity-based MR-Linac guided FSRT Phase 2

Detailed Description:

This Phase II study is to determine the efficacy and safety of MR-Linac Guided Adaptive fractionated stereotactic radiotherapy (FSRT) in patients with brain metastases in non-small cell lung cancer.

Patients will receive FSRT (30Gy in 5 fractions) on the MR-Linac treatment machine. The primary end point is 1-year intracranial progression-free survival. The secondary end points are objective response rate, 1-y PFS, 1-y OS, perilesional edema of brain metastases, quality of life, safety of treatment, dose coverage of targets and dose to normal organs.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 55 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Prospective, Phase II Study of MR-Linac Guided Adaptive Fractionated Stereotactic Radiotherapy for Brain Metastases From Non-small Cell Lung Cancer
Actual Study Start Date : June 1, 2021
Estimated Primary Completion Date : June 1, 2023
Estimated Study Completion Date : June 1, 2023

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: MR-Linac Guided Adaptive FSRT
Patients will receive FSRT (30Gy in 5 fractions) on the MR-Linac treatment machine.
Combination Product: Unity-based MR-Linac guided FSRT
The FSRT was delivered using the Unity-based MR-Linac treatment machine, with a total dose of 30Gy in 5 fractions.




Primary Outcome Measures :
  1. 1-year intracranial progression-free survival [ Time Frame: 1 year ]

Secondary Outcome Measures :
  1. Objective response rate [ Time Frame: 2 months ]
  2. 1-year progression-free survival [ Time Frame: 1 year ]
  3. 1-year overall survival [ Time Frame: 1 year ]
  4. Rate of participants with perilesional edema of brain metastases evaluated byT2-weighted MRI [ Time Frame: 1 year ]
  5. Quality of life evaluated by EORTC quality of life questionnaire [ Time Frame: 1 year ]
  6. Rate of patients with treatment-related adverse events evaluated by CTCAE v4.0 [ Time Frame: 1 year ]
  7. Dose coverage to targets [ Time Frame: 2 months ]
  8. Dose to normal organs [ Time Frame: 2 months ]


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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Aged 18-75 years
  • Histologically or cytologically confirmed non-small cell lung cancer
  • 1-10 metastases on contrast-enhanced MRI
  • Radiotherapy for extracranial lesions is permitted
  • Tyrosine kinase inhibitors (TKI) are permitted in patients with progression of intracranial metastases during previous TKI therapy
  • Patients have measurable or evaluable lesions based on the Response Evaluation Criteria in Solid Tumors (RECIST) criteria
  • Eastern Cooperative Oncology Group (ECOG) performance status 0-1
  • Normal function of organs and bone marrow within 14 days: Total bilirubin 1.5 times or less the upper limits of normal (ULN); AST and ALT 1.5 times or less the ULN; absolute neutrophil count≥ 500 cells/mm3; creatinine clearance rate(CCR) ≥45 mL/min; Platelet count≥50,000 cells/mm3; international normalized ratio(INR) ≤1.5#Prothrombin Time (PT)≤ 1.5 × ULN
  • Informed-consent

Exclusion Criteria:

  • Small cell carcinoma of lung
  • Intracranial metastases needed surgical decompression
  • Patients with contraindications for MRI
  • Previous radiotherapy or excision for intracranial metastases
  • The tumor has completely approached, encircled, or invaded the intravascular space of the great vessels (e.g., the pulmonary artery or the superior vena cava)
  • A cavity over 2cm in diameter of primary tumor or metastasis
  • Bleeding tendency or coagulation disorder
  • Hemoptysis (1/2 teaspoon blood/day) happened within 1 month
  • The use of full-dose anticoagulation within the past 1 month
  • Severe vascular disease occurred within 6 months
  • Gastrointestinal fistula, perforation or abdominal abscess occurred within 6 months
  • Hypertensive crisis, hypertensive encephalopathy, symptomatic heart failure (New York class II or above), active cerebrovascular disease or cardiovascular disease occurred within 6 months
  • Uncontrolled hypertension (systolic > 150mmHg and/or diastolic > 100mmHg)
  • Major surgery within 28 days or minor surgery or needle biopsy within 48 hours
  • Urine protein 3-4+, or 24h urine protein quantitative >1g
  • Severe uncontrolled disease
  • Uncontrollable seizure or psychotic patients without self-control ability
  • Women in pregnancy, lactation period
  • Other not suitable conditions determined by the investigators

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): NCT04946019


Contacts
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Contact: Daquan Wang, M.D +86-020-87343031 wangdq@sysucc.org.cn
Contact: Bo Qiu, M.D +86-020-87343031 qiubo@sysucc.org.cn

Locations
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China, Guangdong
Hui Liu Recruiting
Guangzhou, Guangdong, China, 510060
Contact: Hui Liu, Prof.    +86-020-87343031    liuhui@sysucc.org.cn   
Sponsors and Collaborators
Sun Yat-sen University
Investigators
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Principal Investigator: Hui Liu, Ph.D Sun Yat-sen University
Publications:

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Responsible Party: Hui Liu, Professor, Sun Yat-sen University
ClinicalTrials.gov Identifier: NCT04946019    
Other Study ID Numbers: GASTO-1075
First Posted: June 30, 2021    Key Record Dates
Last Update Posted: June 30, 2021
Last Verified: June 2021
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 Hui Liu, Sun Yat-sen University:
Non-small cell lung cancer
MR-Linac
Fractionated stereotactic radiation therapy
Brain metastase
Additional relevant MeSH terms:
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Lung Neoplasms
Brain Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Bronchial Neoplasms
Central Nervous System Neoplasms
Nervous System Neoplasms
Brain Diseases
Carcinoma, Non-Small-Cell Lung
Lung Diseases
Respiratory Tract Diseases
Carcinoma, Bronchogenic
Central Nervous System Diseases
Nervous System Diseases