Stereotactic Radiosurgery Combination With Anlotinib for Limited Brain Metastases in NSCLC

NCT ID: NCT04912128

Last Updated: 2021-06-03

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 30 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2017-01-15
• Study Completion Date: 2021-06-01

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 metastases.

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 cancer with limited brain metastases. Patients in Anlotinib group took Anlotinib 1 week before the MRI-based simulation，12mg/d QD，day1~14, 21d/cycle. Patients in SBRT group took no anti-angiogenic drugs. All patients received SBRT for brain metastases.

Conditions

Stereotactic Body Radiation Therapy

Study Design

• Observational Model Type: CASE_CONTROL
• Study Time Perspective: RETROSPECTIVE

Study Groups

Anlotinib group

Patients in Anlotinib group took Anlotinib 1 week before the MRI-based simulation，12mg/d QD，day1\~14, 21d/cycle. All patients received SBRT for brain metastases.

Anlotinib

Intervention Type: DRUG

Anlotinib is a novel multi-target tyrosine Kinase inhibitor that inhibits VEGFR2/3, FGFR1-4, PDGFD α/β, c-Kit and Ret.

Stereotactic Radiosurgery Stereotactic Radiosurgery as the initial treatment of non small cell lung cancer patients with limited brain metastases

SBRT group

Patients in SBRT group took no anti-angiogenic drugs. All patients received SBRT for brain metastases.

No interventions assigned to this group

Interventions

Anlotinib

Anlotinib is a novel multi-target tyrosine Kinase inhibitor that inhibits VEGFR2/3, FGFR1-4, PDGFD α/β, c-Kit and Ret.

Stereotactic Radiosurgery Stereotactic Radiosurgery as the initial treatment of non small cell lung cancer patients with limited brain metastases

Intervention Type: DRUG

Other Intervention Names

Antiangiogenic agents

Eligibility Criteria

Inclusion Criteria

1. Patients pathologically diagnosed as non-small cell lung cancer, with brain metastases and measurable lesions;

2. Patients aged between 18 -80 years; with expected survival time>3 months.

3. Patients with no more than 5 brain metastases

4. Patients with normal organ function within 7 days prior to treatment, the following criteria are met:

1. 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 Criteria

1. Patients who had previously used antiangiogenic agents within 1 month;

2. Patients with small cell lung cancer (including small cell carcinoma and non-small cell carcinoma mixed lung cancer);

3. Patient with lung squamous cell carcinoma that involved pulmonary hilar, or non-small cell lung cancer with hemoptysis;

4. Patients with cerebral infarction and cerebral hemorrhage;

5. Patients without perilesional edema；

6. Patients with more than grade 2 (NCI-CTCAE v4.0) acute toxicity reaction due to any previous treatment.

7. Patients with factors that affect oral medication (such as cannot swallow, chronic diarrhea and intestinal obstruction, etc.);

8. Patients with visceral dissemination or severe symptoms, which could cause death in short term;

9. Patients with any other severe and/or uncontrolled disease;

10. Patients who received a surgery, a biopsy or a significant traumatic injury within 1 month;

11. Patients with any signs or medical history of bleeding, unhealed wounds, ulcers or fractures, regardless of the severity;

12. Patients underwent artery or venous thrombotic events within 2 months, such as deep vein thrombosis and pulmonary embolism;

13. Patients with a history of psychotropic medicine abuse and cannot quit or have mental disorders;

14. Patients with disease which will severely endanger their security and could not complete this study, according to the judgement of researchers；

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Huashan Hospital

OTHER

Sponsor Role: collaborator

Tianjin Medical University

OTHER

Sponsor Role: collaborator

Peking University Third Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Department of Radiation Oncology Cancer Center, Peking University Third Hospital 49# North Garden Rd.,Haidian Dist.

Beijing, Beijing Municipality, China

Countries

China

Other Identifiers

AnloSBRT

Identifier Type: -

Identifier Source: org_study_id