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NCT02385136 Clinical Trial

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

NSCLC Clinical Trial

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data
NCT number NCT02385136
Other study ID # zjzlyy 2015-1-5
Secondary ID
Status Not yet recruiting
Phase Phase 1/Phase 2
First received March 3, 2015
Last updated March 10, 2015
Start date April 2015
Est. completion date December 2018

Study information
Verified date March 2015
Source Zhejiang Cancer Hospital
Contact n/a
Is FDA regulated No
Health authority China: Food and Drug Administration
Study type Interventional

Clinical Trial 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).

Recruitment information / eligibility
Status Not yet recruiting
Enrollment 135
Est. completion date December 2018
Est. primary completion date December 2016
Accepts healthy volunteers No
Gender Both
Age group 18 Years to 75 Years
Eligibility 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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

Intervention

Drug:
• Temozolomide

Locations
Country Name City State
n/a

Sponsors (2)
Lead Sponsor Collaborator
Zhejiang Cancer Hospital Hangzhou Cancer Hospital

Outcome
Type Measure Description Time frame Safety issue
Primary objective response rate 1 month post procedure No
Primary Time to central nervous system progress which was confirmed by MRI 1 to 24 months post procedure No
Secondary The Quality of Life 0 to 24 months post procedure Yes
Secondary Overall Survival 1 to 24 months post procedure No
Secondary Toxicity as measured by CTCAE V4.0 0 to 24 months post procedure Yes
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