Clinical trial NCT04912128: Stereotactic Radiosurgery Combination With Anlotinib for Limited Brain Metastases in NSCLC
Official title: Stereotactic Radiosurgery Combination With Anlotinib for Limited Brain Metastases in Non-small Cell Lung Cancer
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Stereotactic Body Radiation Therapy
Lead sponsor: Peking University Third Hospital
Sponsor class: OTHER
Collaborators: name: Huashan Hospital
name: Tianjin Medical University
First posted: 2021-06-03
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Observational model: CASE_CONTROL
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: NSCLC patients with limited brain metastases who received stereotactic radiosurgery with or without Anlotinib treatment.

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.

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；

Primary outcomes:
measure: PFS
timeFrame: 1 years
Secondary outcomes:
measure: OS
timeFrame: 1 years
measure: ORR
timeFrame: 3 months
measure: DCR
timeFrame: 3 months
measure: iORR
timeFrame: 3 months
measure: iPFS
timeFrame: 3 months
Other outcomes:
Locations:
city: Beijing
country: China
facility: Department of Radiation Oncology Cancer Center, Peking University Third Hospital 49# North Garden Rd.,Haidian Dist.
state: Beijing
Study officials:
References: