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

Non Small Cell Lung Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05588206
• Other study ID #: DeHSRT
• Status: Recruiting
• Phase: Phase 1/Phase 2
• Start date: January 1, 2022
• Est. completion date: December 31, 2024

Study information

• Verified date: October 2022
• Source: First People's Hospital of Hangzhou
• Contact: Bing Xia
• Phone: 057156006382
• Email: bingxia_hzch[@]163.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 21
• Est. completion date: December 31, 2024
• Est. primary completion date: December 31, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Brain Metastases
• Brain Neoplasms
• Carcinoma, Non-Small-Cell Lung
• Lung Neoplasms
• Neoplasm Metastasis
• Non Small Cell Lung Cancer
• Stage IV Non-small Cell Lung Cancer

Intervention

Radiation:
• Hypofractionated 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.

Locations

Country	Name	City	State
China	Kaicheng Pan	Hangzhou

Sponsors (2)

Lead Sponsor	Collaborator
First People's Hospital of Hangzhou	Hangzhou Cancer Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	MTD	maximum tolerated dose	1 years
Secondary	ARE	adverse radiation effect	2 years
Secondary	iPFS	intracranial progression-free survival defines as intervals from treatment to intracranial disease progression or death	2 years
Secondary	OS	overall survival (OS) intervals from treatment to death or last follow-up	2 years