Stereotactic Radiotherapy Plus Temozolomide for Refractory Brain Metastases

Brain Metastases Clinical Trial

— SRTRBM  

Official title:

Fractionated Stereotactic Radiotherapy Combined With Temozolomide for Refractory Brain Metastases: A Single-arm, Single-center Phase II Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02654106
• Other study ID #: CH-H&N-003
• Status: Completed
• Phase: Phase 2
• First received: January 10, 2016
• Last updated: June 5, 2017
• Start date: October 2011
• Est. completion date: November 2015

Study information

• Verified date: June 2017
• Source: Chinese Academy of Medical Sciences
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This clinical trial was designed to investigate the efficiency and toxicity of fractionated stereotactic radiotherapy(FSRT) combined with Temozolomide(TMZ) for refractory brain metastases.

Description:

This is a single-arm, single center, phase II trial to investigate the feasibility and toxicity of FSRT plus TMZ for refractory brain metastases, which are defined as A: multiple brain metastases(≥3 lesions); B: large brain metastases(with one lesion's volume is no smaller than 6cc or the longest diameter is no shorter than 3cm); C: meningeal metastases.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 65
• Est. completion date: November 2015
• Est. primary completion date: November 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

Inclusion Criteria:

• Histologic or cytologic diagnosis of primary tumor and conformed brain metastases by enhanced MRI or CT

• the lesion number is no less than 3; or the tumor volume is no smaller than 6cc; or tumor diameter is no shorter than 3cm; or uncontrolled brain tumor after whole brain radiotherapy(WBRT); or the tumor is adjacent to essential structures of the brain, such as brain stem, optic chiasma, optic tract, etc.

• KPS =60,or KPS =40 and the limitation of motion is simply caused by brain tumor that is adjacent to the motor function areas.

• Age: 18-75 years old.

• Adequate end-organ function:

WBC=4.0x109/L Neu = 1.5x109/L Hemoglobin = 110 g/L Platelets =100 x109/L Total bilirubin = 1.5x ULN AST and ALT = 1.5x ULN BUN and Cr: within the normal range

Exclusion Criteria:

• Other clinically significant diseases (e.g.myocardial infarction within the past 6 months, severe arrhythmia).

• Unable or unwilling to comply with the study protocol.

• The expected survival time is less than 3 months.

• Patients who are anticipated in other clinical trials of brain metastases.

• Patients who has been treated with SRT in other hospitals

• Pregnant patients or female patients whose HCG is positive

• Unsuitable to participate in study, that in the opinion of the treating physician.

Related Conditions & MeSH terms

• Brain Metastases
• Brain Neoplasms
• Neoplasm Metastasis
• Neoplasms, Second Primary

Intervention

Radiation:
• Fractionated Stereotactic Radiotherapy
The regular fraction modes were as follows: a. lesions=3 cm:52Gy/4Gy/13f or 52.5Gy/3.5Gy/15f; b. lesions<2cm:36Gy/12Gy/3f or 24Gy/24Gy/1f; for lesions located in function areas, it would be adjusted to 40Gy/8Gy/5f; c. lesions 2-3cm:40-48Gy/8-10Gy/6-4f; d. lesions located in brainstem:50-60Gy/2.5-3Gy/20f.

Drug:
• Temozolomide
concomitant TMZ: 75mg/m2 adjuvant TMZ: 150mg/m2*5d, q28d, 6cycles

Locations

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

Sponsors (2)

Lead Sponsor	Collaborator
Chinese Academy of Medical Sciences	Cancer Foundation, China

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	intracranial progress free survival rate	defined as no progress of the treated lesions and no distant progress in the brain	up to 2 years
Secondary	Overall survival rate		up to 3 year
Secondary	progress free survival rate		up to 1 year
Secondary	local control rate		up to 1 year
Secondary	disease control rate (DCR)	Using RTOG9508 criteria, Tumor control is defined as CR+PR+SD	2-3 months after radiation
Secondary	adverse event	assessed by CTCAE criteria, v4.0 and RTOG criteria of the central nervous system	from the day of radiation to the end of adjuvant TMZ,up to 6 months
Secondary	causes of death	collect the data of causes of death and analyze	from the day of radiation to death date, up to 5 years