Erlotinib With Concurrent Brain Radiotherapy and Secondary Brain Radiotherapy After Recurrence With Erlotinib in NSCLC Non-increased-intracranial-pressure Symptomatic Brain Metastases

Sponsor
Wu Jieping Medical Foundation
Study ID
NCT01763385
Phase
PHASE2
Status
Unknown

Conditions

  • Brain Metastases
  • Non-small-cell Lung Cancer

Eligibility Criteria

Sex
ALL
Age
18 Years - 85 Years
Healthy Volunteers
Not accepted

Interventions

  • Erlotinib — DRUG
  • concurrent brain radiotherapy — RADIATION
  • secondary brain radiotherapy — RADIATION

Study Details

This project is aim to explore non-increased-intracranial-pressure symptomatic brain metastases of NSCLC, and if the OS of secondary brain radiotherapy after recurrence with Erlotinib is better than Erlotinib with concurrent brain radiotherapy. Treatment group are treated with Erlotinib until brain tumor progression, then gave brain radiotherapy, and continued to take Erlotinib till extracranial lesions progression. Control group are Erlotinib with concurrent brain radiotherapy, and continued to take Erlotinib after radiotherapy until recurrence or termination for other reasons.

Key Dates

First listed
Jan 8, 2013
Start date
Nov 30, 2012
Status verified
Dec 2014
Primary completion
May 31, 2016
Completion
May 31, 2016

Study Design

Enrollment
210 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Erlotinib & secondary brain radiotherapy
    Erlotinib until brain tumor progression, then given brain radiotherapy, and continued to take Erlotinib till extracranial lesions progression.
  • Other: Erlotinib & concurrent brain radiotherapy
    Erlotinib with concurrent brain radiotherapy, and continued to take Erlotinib after radiotherapy until recurrence or termination for other reasons

Primary Outcome Measure

overall survival [ Time Frame: 3.5year ]

Central Contacts

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