NCT04178330

Brief Summary

This clinical trial was designed to investigate the efficiency and toxicity of tomotherapy as primary radiotherapy for multiple brain metastases.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
82

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Sep 2014

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2014

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 13, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 13, 2017

Completed
2.5 years until next milestone

First Submitted

Initial submission to the registry

November 25, 2019

Completed
1 day until next milestone

First Posted

Study publicly available on registry

November 26, 2019

Completed
Last Updated

November 26, 2019

Status Verified

November 1, 2019

Enrollment Period

2.8 years

First QC Date

November 25, 2019

Last Update Submit

November 25, 2019

Conditions

Brain Metastases

Keywords

multiple brain metastasesTomotherapyfractionated stereotactic radiotheray

Outcome Measures

Primary Outcomes (1)

  • Disease control rate(DCR)

    Using RTOG9508 criteria, tumor control is defined as CR+PR+SD

    2-3 month after radiation

Secondary Outcomes (5)

  • Overall survival

    up to 3 years

  • progress free survival

    up to 1 year

  • local control rate

    up to 1 year

  • intracranial progress free survival rate

    up to 1 year

  • adverse event

    from the day of radiation, up to 3 years

Study Arms (1)

Group A

EXPERIMENTAL

patients with multiple brain metastases (no less than 3 lesions) ,who have not recived whole brain radiotheray (WBRT).

Radiation: tomotherapy

Interventions

tomotherapyRADIATION

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.

Group A

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Chinese Academy of Medical Sciences

Beijing, Beijing Municipality, 100021, China

Location

MeSH Terms

Conditions

Brain Neoplasms

Interventions

Radiotherapy, Intensity-Modulated

Condition Hierarchy (Ancestors)

Central Nervous System NeoplasmsNervous System NeoplasmsNeoplasms by SiteNeoplasmsBrain DiseasesCentral Nervous System DiseasesNervous System Diseases

Intervention Hierarchy (Ancestors)

Radiotherapy, ConformalRadiotherapy, Computer-AssistedRadiotherapyTherapeutics

Study Officials

  • Jianping Xiao

    Chinese Academy of Medical Sciences

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Dr

Study Record Dates

First Submitted

November 25, 2019

First Posted

November 26, 2019

Study Start

September 1, 2014

Primary Completion

June 13, 2017

Study Completion

June 13, 2017

Last Updated

November 26, 2019

Record last verified: 2019-11

Data Sharing

IPD Sharing
Will not share

Locations

CN(1)