NCT03338075

Brief Summary

A propensity- matched study was conducted to investigate the feasibility and safety of adding temozolomide to hypofractionated stereotactic radiotherapy for large brain metastases.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
72

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jan 2016

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

January 1, 2016

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2017

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

November 7, 2017

Completed
2 days until next milestone

First Posted

Study publicly available on registry

November 9, 2017

Completed
Last Updated

November 9, 2017

Status Verified

November 1, 2017

Enrollment Period

1.6 years

First QC Date

November 7, 2017

Last Update Submit

November 7, 2017

Conditions

Brain MetastasesRadiotherapyChemotherapy

Outcome Measures

Primary Outcomes (1)

  • Local tumor control rate (LTCR)

    the control rate of treated lesions

    3 months after radiation

Secondary Outcomes (5)

  • Intracranial progression- free survival (IPFS)

    up to 1 year

  • Local recurrence- free survival (LRFS)

    up to 1 year

  • Overall survival (OS)

    up to 3 years

  • Progression- free survival (PFS)

    up to 1 year

  • Brain metastasis-specific survival (BMSS)

    up to 1 year

Study Arms (2)

CRT group

patients with brain metastases of more than 6 cc and treated with fractionated stereotactic radiotherapy plus concomitant Temozolomide.

Radiation: fractionated stereotactic radiotherapy

RT group

patients with brain metastases of more than 6 cc and treated with fractionated stereotactic radiotherapy alone.

Radiation: fractionated stereotactic radiotherapy

Interventions

fractionated stereotactic radiotherapyRADIATION

The regular prescription doses were 52 Gy in 13 fractions or 52.5 Gy in 15 fractions.

Also known as: drugs
CRT groupRT group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

patients with large brain metastases of more than 6 cc.

You may qualify if:

  • (1) primary tumor was pathologically diagnosed and brain metastases were confirmed by gadolinium-enhanced magnetic resonance imaging (MRI) ; (2) age 18 years or older (3) KPS ≥60, or KPS ≥50 but symptomatically caused by BMs; (4) the large lesions haven't treated with surgery or SRT.

You may not qualify if:

  • (1) KPS \<60 but not caused by BMs; (2) the large lesions have been treated with surgery or SRT.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Brain Neoplasms

Interventions

Pharmaceutical Preparations

Condition Hierarchy (Ancestors)

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

Study Officials

  • Jianping Xiao, Dr

    Cancer Institute and Hospital, Chinese Academy of Medical Sciences

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Dr

Study Record Dates

First Submitted

November 7, 2017

First Posted

November 9, 2017

Study Start

January 1, 2016

Primary Completion

August 1, 2017

Study Completion

August 1, 2017

Last Updated

November 9, 2017

Record last verified: 2017-11

Data Sharing

IPD Sharing
Will not share