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

Zhejiang University

Status and phase: Enrolling; Phase 2; Phase 1

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

Treatments: Radiation: Hypofractionated Stereotactic Radiotherap

Study type: Interventional

Funder types: Other

Identifiers

NCT05588206

DeHSRT

Details and patient eligibility

About

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.

Full 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.

Enrollment: 21 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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21 participants in 1 patient group

Hypofractionated Stereotactic Radiotherapy for Brain Metastases

Experimental group

Treatment:

Radiation: Hypofractionated Stereotactic Radiotherap