Dose-escalation by Hypofractionated Stereotactic Radiotherapy for Brain Metastases in Non Small Cell Lung Cancer

Study Overview
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Brief Summary
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The objective of this trial is to assess the safety and feasibility of delivering SBRT to patients with limited BMs (less than 10 lesions of lung cancer) by establishing the maximally tolerated dose (MTD) of SABR in 5 fractions.

Detailed Description
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The objective of this trial is to assess the safety and feasibility of delivering SBRT to patients with limited BMs (less than 10 lesions of lung cancer) by establishing the maximally tolerated dose (MTD) of SABR in 5 fractions.

Official Title
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Dose-escalation by Hypofractionated Stereotactic Radiotherapy Simultaneous Integrated Boost IMRT for Brain Metastases in Non Small Cell Lung Cancer：A Phase I Study

Conditions
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Non Small Cell Lung Cancer, Stage IV Non-small Cell Lung Cancer, Brain Metastases

Intervention / Treatment
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* Radiation: Hypofractionated Stereotactic Radiotherap


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Histology confirmed that it was non-small cell lung cancer 1 to 10 brain metastases detected by magnetic resonance imaging (MRI) A life expectancy of >3 months according to the DS GPA. KPS ≥70 Control of the primary lesions (thorax) at the time of SBRT 2cm<Tumor size ≤ 4 cm Age of 18-75 years old Patients must be able to undergo contrast enhanced MRI for planning Adequate bone marrow and organ function Exclusion Criteria: other malignant tumors Prior surgery to brain metastasis Prior brain radiotherapy Non-small cell lung cancer with more than 10 brain metastases detected by MRI Contraindication to receiving radiotherapy.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Hypofractionated Stereotactic Radiotherapy for Brain Metastases<br> | Radiation: Hypofractionated Stereotactic Radiotherap<br>* A standard 3+3 statistical design was employed. Three patients will initially be treated at dose level 1, 6 Gy in 5 fractions, 3 fractions a week. Dose limiting toxicities (DLT) were defined as any grade 3-5 radiation injury or any non-hematologic toxicity felt to be possibly, probably, or definitely related to radiation, identified within the evaluation period of 3 months following the completion of radiotherapy.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| MTD | maximum tolerated dose | 1 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| ARE | adverse radiation effect | 2 years | 
| iPFS | intracranial progression-free survival defines as intervals from treatment to intracranial disease progression or death | 2 years | 
| OS | overall survival (OS) intervals from treatment to death or last follow-up | 2 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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lung cancer, Brain Metastases, Hypofractionated Stereotactic Radiotherapy