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

First People's Hospital of Hangzhou21 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

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

Interventions

Hypofractionated Stereotactic RadiotherapRADIATION

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.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

Locations (1)

Kaicheng Pan

Hangzhou, China

RECRUITING

Outcomes

Primary Outcomes

MTD

maximum tolerated dose

Time frame: 1 years

Secondary Outcomes

ARE

adverse radiation effect

Time frame: 2 years

iPFS

intracranial progression-free survival defines as intervals from treatment to intracranial disease progression or death

Time frame: 2 years

overall survival (OS) intervals from treatment to death or last follow-up

Time frame: 2 years

Central Contacts

Bing Xia

CONTACT

057156006382 bingxia_hzch@163.com

Data from ClinicalTrials.gov

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