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

Zhejiang Cancer Hospital135 enrolled

Overview

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).

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

NONE

Enrollment

135

Conditions

NSCLC

Interventions

TemozolomideDRUG

Eligibility

Sex: ALLMin age: 18 YearsMax age: 75 Years

Medical Language ↔ Plain English

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.

Outcomes

Primary Outcomes

objective response rate

Time frame: 1 month post procedure

Time to central nervous system progress which was confirmed by MRI

Time frame: 1 to 24 months post procedure

Secondary Outcomes

The Quality of Life

Time frame: 0 to 24 months post procedure

Overall Survival

Time frame: 1 to 24 months post procedure

Toxicity as measured by CTCAE V4.0

Time frame: 0 to 24 months post procedure

Data from ClinicalTrials.gov

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