NCT05588206
Recruiting
Phase 1
Dose-escalation by Hypofractionated Stereotactic Radiotherapy Simultaneous Integrated Boost IMRT for Brain Metastases in Non Small Cell Lung Cancer：A Phase I Study
First People's Hospital of Hangzhou1 site in 1 country21 target enrollmentJanuary 1, 2022
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- Non Small Cell Lung Cancer
- Sponsor
- First People's Hospital of Hangzhou
- Enrollment
- 21
- Locations
- 1
- Primary Endpoint
- MTD
- Status
- Recruiting
- Last Updated
- 3 years ago
Overview
Brief Summary
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
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.
Investigators
Eligibility Criteria
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.
- •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.
Outcomes
Primary Outcomes
MTD
Time Frame: 1 years
maximum tolerated dose
Secondary Outcomes
- ARE(2 years)
- iPFS(2 years)
- OS(2 years)
Study Sites (1)
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