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Clinical Trials/NCT02385136
NCT02385136
Unknown
Phase 1

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

Zhejiang Cancer Hospital0 sites135 target enrollmentApril 2015
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ConditionsNSCLC
InterventionsTemozolomide
DrugsTemozolomide

Overview

Phase
Phase 1
Intervention
Temozolomide
Conditions
NSCLC
Sponsor
Zhejiang Cancer Hospital
Enrollment
135
Primary Endpoint
Time to central nervous system progress which was confirmed by MRI
Last Updated
11 years ago
OverviewInvestigatorsEligibility CriteriaArms & InterventionsOutcomesSimilar Trials

Overview

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).

Registry
clinicaltrials.gov
Start Date
April 2015
End Date
December 2018
Last Updated
11 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

chenjianxiang

Dr Chen

Zhejiang Cancer Hospital

Eligibility Criteria

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.

Arms & Interventions

WBRT plus TMZ arm

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

Intervention: Temozolomide

Outcomes

Primary Outcomes

Time to central nervous system progress which was confirmed by MRI

Time Frame: 1 to 24 months post procedure

objective response rate

Time Frame: 1 month post procedure

Secondary Outcomes

  • Overall Survival(1 to 24 months post procedure)
  • The Quality of Life(0 to 24 months post procedure)
  • Toxicity as measured by CTCAE V4.0(0 to 24 months post procedure)

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