Apatinib Combined With Radiotherapy in Patient With BM From Drive Gene Negative NSCLC

Sponsor
Hubei Cancer Hospital
Study ID
NCT03801200
Phase
PHASE2
Status
Unknown

Conditions

Eligibility Criteria

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

Interventions

  • Apatinib — DRUG
    radiotherapy with Apatinib

Study Details

The purpose of this study is to evaluate the efficacy and safety of concurrent radiotherapy with Apatinib in patients with Brain Metastases from drive gene wide-type Non-small-cell Lung Cancer (NSCLC).

Key Dates

Start date
Sep 10, 2020
Status verified
Feb 2022
Primary completion
Sep 10, 2021
Completion
Sep 10, 2023

Study Design

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

Arms

  • Experimental: Apatinib combined with Radiotherapy
    Drugs: Apatinib Apatinib (500 mg/d) was given orally for one week before the brain radiotherapy, and then, continued to be administered at the same way during the brain radiotherapy period (3 weeks). It was given for another one week after the end of the brain radiotherapy. Radiotherapy: Intensity-modulated radiotherapy (IMRT). According to the patients KPS score, GPA score, the number and size of metastatic lesions can be selected: 1. 37.5Gy/15 fractions of whole brain irradiation for multiple brain metastases were more than 5; 2. The whole brain was irradiated with 37.5Gy/15 and simultaneous integrated boost dose of 52.5Gy/15 to patients with 1-5 metastatic lesions.
  • No Intervention: Radiotherapy alone
    Radiotherapy: Intensity-modulated radiotherapy (IMRT). According to the patients KPS score, GPA score, the number and size of metastatic lesions can be selected: 1. 37.5Gy/15 fractions of whole brain irradiation for multiple brain metastases were more than 5; 2. The whole brain was irradiated with 37.5Gy/15 and simultaneous integrated boost dose of 52.5Gy /15 to patients with 1-5 metastatic lesions.

Primary Outcome Measure

Intracranial progression-free survival (iPFS) [ Time Frame: Evaluated in 24 months since the treatment began ]

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