Status:
COMPLETED
Stereotactic Radiosurgery Combination With Anlotinib for Limited Brain Metastases in NSCLC
Lead Sponsor:
Peking University Third Hospital
Collaborating Sponsors:
Huashan Hospital
Tianjin Medical University
Conditions:
Stereotactic Body Radiation Therapy
Eligibility:
All Genders
18-80 years
Brief Summary
The purpose of this study is to determine whether stereotactic radiosurgery combination with Anlotinib could improve the efficacy and outcomes for non-small cell lung cancer with limited brain metasta...
Detailed Description
This is a retrospective study. The purpose of this study is to determine whether stereotactic radiosurgery combination with Anlotinib could improve the efficacy and outcomes for non-small cell lung ca...
Eligibility Criteria
Inclusion
- Patients pathologically diagnosed as non-small cell lung cancer, with brain metastases and measurable lesions;
- Patients aged between 18 -80 years; with expected survival time\>3 months.
- Patients with no more than 5 brain metastases
- Patients with normal organ function within 7 days prior to treatment, the following criteria are met:
- blood routine examination criteria : i) hemoglobin (HB) ≥90g/L; ii) absolute neutrophil count (ANC) ≥1.5×10e9/L; iii) platelet (PLT) ≥80×10e9/L; b) biochemical tests meet the following criteria: i) total bilirubin (TBIL) ≤1.5 times of upper limit of normal (ULN); ii) alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤2.5 ULN, if liver metastasis occurred, ALT and AST ≤5 ULN; iii) serum creatinine (Cr) ≤1.5 ULN or creatinine clearance (CCr) ≥60mL/min;
Exclusion
- Patients who had previously used antiangiogenic agents within 1 month;
- Patients with small cell lung cancer (including small cell carcinoma and non-small cell carcinoma mixed lung cancer);
- Patient with lung squamous cell carcinoma that involved pulmonary hilar, or non-small cell lung cancer with hemoptysis;
- Patients with cerebral infarction and cerebral hemorrhage;
- Patients without perilesional edema；
- Patients with more than grade 2 (NCI-CTCAE v4.0) acute toxicity reaction due to any previous treatment.
- Patients with factors that affect oral medication (such as cannot swallow, chronic diarrhea and intestinal obstruction, etc.);
- Patients with visceral dissemination or severe symptoms, which could cause death in short term;
- Patients with any other severe and/or uncontrolled disease;
- Patients who received a surgery, a biopsy or a significant traumatic injury within 1 month;
- Patients with any signs or medical history of bleeding, unhealed wounds, ulcers or fractures, regardless of the severity;
- Patients underwent artery or venous thrombotic events within 2 months, such as deep vein thrombosis and pulmonary embolism;
- Patients with a history of psychotropic medicine abuse and cannot quit or have mental disorders;
- Patients with disease which will severely endanger their security and could not complete this study, according to the judgement of researchers；
Key Trial Info
Start Date :
January 15 2017
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
June 1 2021
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT04912128
Start Date
January 15 2017
End Date
June 1 2021
Last Update
June 3 2021
Active Locations (1)
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1
Department of Radiation Oncology Cancer Center, Peking University Third Hospital 49# North Garden Rd.,Haidian Dist.
Beijing, Beijing Municipality, China, 100191