Apatinib Plus Radiotherapy for Patients With Brain Metastases From Non-small-cell Lung Cancer

Sponsor
Shanxi Province Cancer Hospital
Study ID
NCT03356600
Phase
PHASE2
Status
Unknown

Conditions

  • Brain Metastases

Eligibility Criteria

Sex
ALL
Age
18 Years - 75 Years
Healthy Volunteers
Not accepted

Interventions

  • Apatinib plus radiotherapy — COMBINATION_PRODUCT
    Apatinib: Within 1 week before radiotherapy, the dose of Apatinib were 500mg/daily .During radiotherapy,the dose of Apatinib were 250mg/daily. After radiotherapy, if the subject did not have a level 3 or above adverse reaction, investigators consider increasing doses to 500mg. Radiotherapy: The subjects with 1 to 4 metastases receive stereotactic radiosurgery or stereotactic radiation therapy ,and the subjects with more than 4 metastases receive stereotactic radiosurgery plus whole-brain radiation therapy

Study Details

To observe the effectiveness and safety of apatinib combined with radiotherapy for brain metastasis from non-small cell lung cancer patients

Key Dates

Start date
Dec 31, 2017
Status verified
Nov 2017
Primary completion
Jan 31, 2019
Completion
Oct 31, 2019

Study Design

Enrollment
44 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Apatinib plus radiotherapy
    Apatinib: Within 1 week before radiotherapy, the dose of Apatinib were 500mg/daily .During radiotherapy,the dose of Apatinib were 250mg/daily. After radiotherapy, if the subject did not have a level 3 or above adverse reaction, investigators consider increasing doses to 500mg. Radiotherapy: The subjects with 1 to 4 metastases receive stereotactic radiosurgery or stereotactic radiation therapy ,and the subjects with more than 4 metastases receive stereotactic radiosurgery plus whole-brain radiation therapy.

Primary Outcome Measure

The intracranial disease progression free survival time [ Time Frame: tumor assesment every 8 weeks,up to 24 months ]

Central Contacts

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