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

NCT ID: NCT02385136

Last Updated: 2015-03-11

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE1/PHASE2

Total Enrollment

135 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-04-30

Study Completion Date

2018-12-31

Brief Summary

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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).

Detailed Description

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Conditions

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NSCLC

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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WBRT plus TMZ arm

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

Group Type EXPERIMENTAL

Temozolomide

Intervention Type DRUG

WBRT

whole brain radiotherapy (WBRT)

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Temozolomide

Intervention Type DRUG

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Hangzhou Cancer Hospital

OTHER

Sponsor Role collaborator

Zhejiang Cancer Hospital

OTHER

Sponsor Role lead

Responsible Party

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chenjianxiang

Dr Chen

Responsibility Role PRINCIPAL_INVESTIGATOR

Other Identifiers

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zjzlyy 2015-1-5

Identifier Type: -

Identifier Source: org_study_id

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