Stereotactic Radiosurgery Combination With Anlotinib for Limited Brain Metastases in NSCLC

NCT04912128 | Completed DMC

• 1 other identifier: AnloSBRT
• Study Type: observational
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Stereotactic Body Radiation Therapy

Outcome Measures

Primary Outcomes (1)

• PFS

  progression-free survival

  1 years

Secondary Outcomes (5)

• OS

  1 years

• ORR

  3 months

• DCR

  3 months

• iORR

  3 months

• iPFS

  3 months

Study Arms (2)

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.

Drug: Anlotinib

SBRT group

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

Interventions

Anlotinib 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

Also known as: Antiangiogenic agents

Anlotinib group

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

NSCLC patients with limited brain metastases who received stereotactic radiosurgery with or without Anlotinib treatment.

You may qualify if:

• 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;

You may not qualify if:

• 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；

Sponsors & Collaborators

• Peking University Third Hospital: lead
• Huashan Hospital: collaborator
• Tianjin Medical University: collaborator

Study Sites (1)

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

Beijing, Beijing Municipality, 100191, China

Location

MeSH Terms

Interventions

anlotinib; Angiogenesis Inhibitors

Intervention Hierarchy (Ancestors)

Angiogenesis Modulating Agents; Growth Substances; Physiological Effects of Drugs; Pharmacologic Actions; Chemical Actions and Uses; Growth Inhibitors; Antineoplastic Agents; Therapeutic Uses

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 31, 2021
• First Posted: June 3, 2021
• Study Start: January 15, 2017
• Primary Completion: June 1, 2021
• Study Completion: June 1, 2021
• Last Updated: June 3, 2021

Record last verified: 2021-05

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)