Tomotherapy as Primary Radiotherapy for Multipule Brain Metastases

Brain Metastases Clinical Trial

Official title:

Tomotherapy as Primary Radiotherapy for Multipule Brain Metastases:A Single Arm, Single Center,Phase II Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04178330
• Other study ID #: NCC2014 YZ-14-01
• Status: Completed
• Phase: N/A
• Start date: September 1, 2014
• Est. completion date: June 13, 2017

Study information

• Verified date: November 2019
• 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 tomotherapy as primary radiotherapy for multiple brain metastases.

Description:

This is a single-arm, single center, phase II trial to investigate the feasibility and toxicity of tomotherapy as primary radiotherapy for multiple brain metastases(≥3 lesions).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 82
• Est. completion date: June 13, 2017
• Est. primary completion date: June 13, 2017
• 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;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 organ function:WBC=4.0x109/L, Neu = 1.5x109/L, Hemoglobin = 110 g/L, Platelets =100 x109/L, Totalbilirubin = 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 WBRT. 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:
• tomotherapy
Whole brain radiation (WBRT) with 38-40Gy in 20 fractions and concurrent boost of 60-70Gy of the lesions. TMZ is used if necessary: concomitant TMZ: 75mg/m2 adjuvant TMZ: 150mg/ m2*5d, q28d, up to 6cycles.

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	Disease control rate(DCR)	Using RTOG9508 criteria, tumor control is defined as CR+PR+SD	2-3 month after radiation
Secondary	Overall survival	the time from radiation to death	up to 3 years
Secondary	progress free survival	the time from radiation to any progression	up to 1 year
Secondary	local control rate	the time from radiation to the treated brain metastases recurrence	up to 1 year
Secondary	intracranial progress free survival rate	the time from radiation to local recurrence and/or new brain metastases	up to 1 year
Secondary	adverse event	acute and late toxicities	from the day of radiation, up to 3 years