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

Phase 1

Recruiting

• Conditions: Stage IV Non-small Cell Lung Cancer; Non Small Cell Lung Cancer; Brain Metastases
• Interventions: Radiation: Hypofractionated Stereotactic Radiotherap

• Registration Number: NCT05588206
• Lead Sponsor: First People's Hospital of Hangzhou

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.

Study Timeline

• Study Start: 2022-01-01
• Status Verified: 2022-10
• Study First Submitted: 2022-10-18
• Study First Submitted QC: 2022-10-18
• Last Update Submitted: 2022-10-18
• Study First Posted: 2022-10-20
• Last Update Posted: 2022-10-20
• Primary Completion: 2023-12-31
• Study Completion: 2024-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 21

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Hypofractionated Stereotactic Radiotherapy for Brain Metastases	Hypofractionated Stereotactic Radiotherap	-

Primary Outcome Measures

Name	Time	Method
MTD	1 years	maximum tolerated dose

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Kaicheng Pan; 🇨🇳 Hangzhou, China