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

Primary Purpose

NSCLC

Status
Unknown status
Phase
Phase 1
Locations
Study Type
Interventional
Intervention
Temozolomide
Sponsored by
Zhejiang Cancer Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for NSCLC focused on measuring NSCLC, Radiotherpy, Temozolomide

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept 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.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    No Intervention

    Arm Label

    WBRT plus TMZ arm

    WBRT

    Arm Description

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

    whole brain radiotherapy (WBRT)

    Outcomes

    Primary Outcome Measures

    objective response rate
    Time to central nervous system progress which was confirmed by MRI

    Secondary Outcome Measures

    The Quality of Life
    Overall Survival
    Toxicity as measured by CTCAE V4.0

    Full Information

    First Posted
    March 3, 2015
    Last Updated
    March 10, 2015
    Sponsor
    Zhejiang Cancer Hospital
    Collaborators
    Hangzhou Cancer Hospital
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02385136
    Brief Title
    Temozolomide and Concomitant Whole Brain Radiotherapy in NSCLC Patients With Brain Metastases
    Official Title
    Temozolomide and Concomitant Whole Brain Radiotherapy in NSCLC Patients With Brain Metastases: A Randomized Trial
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    March 2015
    Overall Recruitment Status
    Unknown status
    Study Start Date
    April 2015 (undefined)
    Primary Completion Date
    December 2016 (Anticipated)
    Study Completion Date
    December 2018 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Zhejiang Cancer Hospital
    Collaborators
    Hangzhou Cancer Hospital

    4. Oversight

    Data Monitoring Committee
    Yes

    5. Study Description

    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).

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    NSCLC
    Keywords
    NSCLC, Radiotherpy, Temozolomide

    7. Study Design

    Primary Purpose
    Prevention
    Study Phase
    Phase 1, Phase 2
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    135 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    WBRT plus TMZ arm
    Arm Type
    Experimental
    Arm Description
    whole brain radiotherapy (WBRT) concomitantly with temozolomide (TMZ)
    Arm Title
    WBRT
    Arm Type
    No Intervention
    Arm Description
    whole brain radiotherapy (WBRT)
    Intervention Type
    Drug
    Intervention Name(s)
    Temozolomide
    Primary Outcome Measure Information:
    Title
    objective response rate
    Time Frame
    1 month post procedure
    Title
    Time to central nervous system progress which was confirmed by MRI
    Time Frame
    1 to 24 months post procedure
    Secondary Outcome Measure Information:
    Title
    The Quality of Life
    Time Frame
    0 to 24 months post procedure
    Title
    Overall Survival
    Time Frame
    1 to 24 months post procedure
    Title
    Toxicity as measured by CTCAE V4.0
    Time Frame
    0 to 24 months post procedure

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    75 Years
    Accepts Healthy Volunteers
    No
    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.

    12. IPD Sharing Statement

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

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