Back to resultsMR-Linac Guided Adaptive FSRT for Brain Metastases From Non-small Cell Lung Cancer
Primary Purpose
Non-small Cell Lung Cancer
Status
Recruiting
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
Unity-based MR-Linac guided FSRT
Sponsored by
About this trial
This is an interventional treatment trial for Non-small Cell Lung Cancer focused on measuring Non-small cell lung cancer, MR-Linac, Fractionated stereotactic radiation therapy, Brain metastase
Eligibility 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
Sites / Locations
- Hui LiuRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
MR-Linac Guided Adaptive FSRT
Arm Description
Patients will receive FSRT (30Gy in 5 fractions) on the MR-Linac treatment machine.
Outcomes
Primary Outcome Measures
1-year intracranial progression-free survival
Secondary Outcome Measures
Objective response rate
1-year progression-free survival
1-year overall survival
Rate of participants with perilesional edema of brain metastases evaluated byT2-weighted MRI
Quality of life evaluated by EORTC quality of life questionnaire
Rate of patients with treatment-related adverse events evaluated by CTCAE v4.0
Dose coverage to targets
Dose to normal organs
Full Information
NCT ID
NCT04946019
First Posted
June 25, 2021
Last Updated
November 25, 2022
Sponsor
Sun Yat-sen University
1. Study Identification
Unique Protocol Identification Number
NCT04946019
Brief Title
MR-Linac Guided Adaptive FSRT for Brain Metastases From Non-small Cell Lung Cancer
Official Title
A Prospective, Phase II Study of MR-Linac Guided Adaptive Fractionated Stereotactic Radiotherapy for Brain Metastases From Non-small Cell Lung Cancer
Study Type
Interventional
2. Study Status
Record Verification Date
November 2022
Overall Recruitment Status
Recruiting
Study Start Date
June 1, 2021 (Actual)
Primary Completion Date
June 1, 2023 (Anticipated)
Study Completion Date
June 1, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Sun Yat-sen University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Non-small Cell Lung Cancer
Keywords
Non-small cell lung cancer, MR-Linac, Fractionated stereotactic radiation therapy, Brain metastase
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
55 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
MR-Linac Guided Adaptive FSRT
Arm Type
Experimental
Arm Description
Patients will receive FSRT (30Gy in 5 fractions) on the MR-Linac treatment machine.
Intervention Type
Combination Product
Intervention Name(s)
Unity-based MR-Linac guided FSRT
Intervention Description
The FSRT was delivered using the Unity-based MR-Linac treatment machine, with a total dose of 30Gy in 5 fractions.
Primary Outcome Measure Information:
Title
1-year intracranial progression-free survival
Time Frame
1 year
Secondary Outcome Measure Information:
Title
Objective response rate
Time Frame
2 months
Title
1-year progression-free survival
Time Frame
1 year
Title
1-year overall survival
Time Frame
1 year
Title
Rate of participants with perilesional edema of brain metastases evaluated byT2-weighted MRI
Time Frame
1 year
Title
Quality of life evaluated by EORTC quality of life questionnaire
Time Frame
1 year
Title
Rate of patients with treatment-related adverse events evaluated by CTCAE v4.0
Time Frame
1 year
Title
Dose coverage to targets
Time Frame
2 months
Title
Dose to normal organs
Time Frame
2 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Daquan Wang, M.D
Phone
+86-020-87343031
Email
wangdq@sysucc.org.cn
First Name & Middle Initial & Last Name or Official Title & Degree
Bo Qiu, M.D
Phone
+86-020-87343031
Email
qiubo@sysucc.org.cn
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hui Liu, Ph.D
Organizational Affiliation
Sun Yat-sen University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hui Liu
City
Guangzhou
State/Province
Guangdong
ZIP/Postal Code
510060
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Hui Liu, Prof.
Phone
+86-020-87343031
Email
liuhui@sysucc.org.cn
12. IPD Sharing Statement
Plan to Share IPD
No
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MR-Linac Guided Adaptive FSRT for Brain Metastases From Non-small Cell Lung Cancer
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