NCT02385136

Brief Summary

The purpose of this study is to evaluate the safety profile and efficacy of whole brain radiotherapy (WBRT) concomitantly with temozolomide (TMZ) in patients with brain metastases (BM).Patients with BM were randomly assigned to 30 Gy of WBRT with or without concomitant TMZ (75 mg/m2/d) plus two cycles of TMZ (200 mg/m2/d for 5 days).

Trial Health

35
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
135

participants targeted

Target at P75+ for phase_1

Timeline
Completed

Started Apr 2015

Typical duration for phase_1

Status
unknown

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

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 3, 2015

Completed
8 days until next milestone

First Posted

Study publicly available on registry

March 11, 2015

Completed
21 days until next milestone

Study Start

First participant enrolled

April 1, 2015

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2016

Completed
2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2018

Completed
Last Updated

March 11, 2015

Status Verified

March 1, 2015

Enrollment Period

1.7 years

First QC Date

March 3, 2015

Last Update Submit

March 10, 2015

Conditions

NSCLC

Keywords

NSCLCRadiotherpyTemozolomide

Outcome Measures

Primary Outcomes (2)

  • objective response rate

    1 month post procedure

  • Time to central nervous system progress which was confirmed by MRI

    1 to 24 months post procedure

Secondary Outcomes (3)

  • The Quality of Life

    0 to 24 months post procedure

  • Overall Survival

    1 to 24 months post procedure

  • Toxicity as measured by CTCAE V4.0

    0 to 24 months post procedure

Study Arms (2)

WBRT plus TMZ arm

EXPERIMENTAL

whole brain radiotherapy (WBRT) concomitantly with temozolomide (TMZ)

Drug: Temozolomide

WBRT

NO INTERVENTION

whole brain radiotherapy (WBRT)

Interventions

TemozolomideDRUG
WBRT plus TMZ arm

Eligibility Criteria

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

You may qualify if:

  • histologically diagnosed as NSCLC, stage IVb \[ (American Joint of Cancer Committee(AJCC), 2002) \], Brain metastasis
  • no history of hypertension or diabetes.

You may not qualify if:

  • the brain tumor diameter \>5cm; RPA class =3; pregnancy.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Interventions

Temozolomide

Intervention Hierarchy (Ancestors)

DacarbazineTriazenesOrganic ChemicalsImidazolesAzolesHeterocyclic Compounds, 1-RingHeterocyclic Compounds

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Dr Chen

Study Record Dates

First Submitted

March 3, 2015

First Posted

March 11, 2015

Study Start

April 1, 2015

Primary Completion

December 1, 2016

Study Completion

December 1, 2018

Last Updated

March 11, 2015

Record last verified: 2015-03