Temozolomide and Concomitant Whole Brain Radiotherapy in NSCLC Patients With Brain Metastases

Temozolomide and Concomitant Whole Brain Radiotherapy in NSCLC Patients With Brain Metastases: A Randomized Trial

Status

UNKNOWN

Phases

Phase 1Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02385136

Enrollment

135

Registered

2015-03-11

Start date

2015-04-30

Completion date

2018-12-31

Last updated

2015-03-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

NSCLC

Keywords

NSCLC, Radiotherpy, Temozolomide

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).

Interventions

DRUGTemozolomide

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

PREVENTION

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 75 Years

Healthy volunteers

Inclusion criteria

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

Exclusion criteria

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

Design outcomes

Primary

Measure	Time frame
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

Measure	Time frame
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

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026