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

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

Status

UNKNOWN

Phases

Phase 1Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT05588206

Enrollment

Registered

2022-10-20

Start date

2022-01-01

Completion date

2024-12-31

Last updated

2022-10-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

Keywords

lung cancer, Brain Metastases, Hypofractionated Stereotactic Radiotherapy

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

Interventions

RADIATIONHypofractionated Stereotactic Radiotherap

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.

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

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.

Design outcomes

Primary

Measure	Time frame	Description
MTD	1 years	maximum tolerated dose

Secondary

Measure	Time frame	Description
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

Countries

China

Contacts

Primary ContactBing Xia

bingxia_hzch@163.com057156006382

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026