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

University of Chinese Academy Sciences

Status and phase: Unknown; Phase 2; Phase 1

Conditions: NSCLC

Treatments: Drug: Temozolomide

Study type: Interventional

Funder types: Other

Identifiers

NCT02385136

zjzlyy 2015-1-5

Details and patient eligibility

About

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).

Enrollment: 135 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No 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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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135 participants in 2 patient groups

WBRT plus TMZ arm

Experimental group

Description:

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

Treatment:

Drug: Temozolomide

WBRT

No Intervention group

Description:

whole brain radiotherapy (WBRT)