HFSRT With Concurrent TMZ for Large BMs

Brain Metastases Clinical Trial

Official title:

Hypofractionated Radiotherapy With Concurrent Temozolomide for Large Brain Metastases: a Multi-center Randomized Phase III Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03778541
• Other study ID #: LBM-RCT
• Status: Recruiting
• Phase: Phase 3
• Start date: December 3, 2018
• Est. completion date: December 3, 2022

Study information

• Verified date: July 2019
• Source: Chinese Academy of Medical Sciences
• Contact: Jianping Xiao, Dr
• Phone: +8613811026919
• Email: jpxiao8[@]163.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

A multi-center randomized phase III trial was conducted to investigate the feasibility and safety of adding temozolomide to hypofractionated stereotactic radiotherapy for large brain metastases.

Description:

A previous single arm phase II trial and propensity- matched study of our institution have shown that HFSRT combined with concurrent TMZ was safe and efficient for patients with BMs of ≥ 6cc in volume. The 1-year local control, intracranial progression free survival, progression free survival and overall survival rates were better than HFSRT alone group. Thus, the investigator conducted this randomized phase III trial to broad the sample size and verify our previous results. To finish the study in time, the investigator designed a multi-center trial.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 224
• Est. completion date: December 3, 2022
• Est. primary completion date: December 3, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

Inclusion Criteria:

• histologic or cytological diagnosis of primary tumor and conformed brain metastases by enhanced MRI or CT;

• the number of BMs = 3

• the tumor volume =6cc, or maximum diameter of BMs= 3cm;

• Karnofsky performance score (KPS)=60, or KPS=40 but simply caused by BMs;

• Age: 18-75 years old;

• Adequate function of major organs, and blood test reached the following level:

WBC=4.0x109/L, NEU=1.5x109/L Hemoglobin=110 g/L, Platelets=100 x109/L; Liver function test results<1.5 times the institutional upper limit of normal (ULN); BUN and Cr: within the normal range.

Exclusion Criteria:

• patient with other clinically significant diseases (e.g. myocardial infarction within the past 6 months, severe arrhythmia);

• unable or unwilling to comply with the study protocol;

• patient whose survival expectancy was less than 3 months;

• the large BM locates in brainstem;

• patient who anticipated in other clinical trials of brain metastases;

• the large lesions have been treated with SRT in other hospitals;

• pregnant patients or female patients whose HCG is positive.

Related Conditions & MeSH terms

• Brain Metastases
• Brain Neoplasms
• Chemotherapy
• Neoplasm Metastasis
• Radiotherapy

Intervention

Drug:
• Temozolomide
75mg/m2/d concurrent with radiotherapy, taken for at least 20 days.

Radiation:
• hypofractionated radiotherapy
the regular radiation dose prescription is 52 Gy in 13 fractions or 52.5 Gy in 15 fractions.

Locations

Country	Name	City	State
China	Chinese Academy of Medical Sciences	Beijing	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Chinese Academy of Medical Sciences

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	intracranial progression free survival (IPFS) rate	IPFS was defined as the interval from the beginning of radiation to any intracranial progression	up to 2 years
Secondary	local control rate	the control rate of treated lesions	up to 2 years
Secondary	Brain metastasis-specific survival (BMSS) rate	BMSS was defined as the internal from the beginning of RT to death caused by BM	up to 2 years
Secondary	overall survival (OS) rate	OS was defined as the internal from the beginning of RT to death caused by any reason	up to 2 years
Secondary	Number of participants with treatment-related adverse events as assessed by CTCAE v4.0 and NRG/RTOG CNS toxicities criteria	the toxicities caused by RT and (or) Chemotherapy	acute toxicities: up to 3 months after RT; Late toxicities: up to 2 years after RT