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

March 10, 2015 updated by: chenjianxiang, Zhejiang Cancer Hospital

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

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 Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

135

Phase

  • Phase 2
  • Phase 1

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: WBRT plus TMZ arm
whole brain radiotherapy (WBRT) concomitantly with temozolomide (TMZ)
Drug: Temozolomide
No Intervention: WBRT
whole brain radiotherapy (WBRT)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
objective response rate
Time Frame: 1 month post procedure
1 month post procedure
Time to central nervous system progress which was confirmed by MRI
Time Frame: 1 to 24 months post procedure
1 to 24 months post procedure

Secondary Outcome Measures

Outcome Measure
Time Frame
The Quality of Life
Time Frame: 0 to 24 months post procedure
0 to 24 months post procedure
Overall Survival
Time Frame: 1 to 24 months post procedure
1 to 24 months post procedure
Toxicity as measured by CTCAE V4.0
Time Frame: 0 to 24 months post procedure
0 to 24 months post procedure

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Zhejiang Cancer Hospital

Collaborators

Hangzhou Cancer Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2015

Primary Completion (Anticipated)

December 1, 2016

Study Completion (Anticipated)

December 1, 2018

Study Registration Dates

First Submitted

March 3, 2015

First Submitted That Met QC Criteria

March 10, 2015

First Posted (Estimate)

March 11, 2015

Study Record Updates

Last Update Posted (Estimate)

March 11, 2015

Last Update Submitted That Met QC Criteria

March 10, 2015

Last Verified

March 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • zjzlyy 2015-1-5

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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