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Completed

NCT Number: NCT04912128

Stereotactic Radiosurgery Combination With Anlotinib for Limited Brain Metastases in NSCLC

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.

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Key information

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Observational

Primary location

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

Beijing, Beijing Municipality, 100191, China

About this study

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.

Who can participate

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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 criteria

  • 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;

Treatment and study plan

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

Other names: Antiangiogenic agents

Primary outcomes

  1. PFS

    Time frame: 1 years

    progression-free survival

Secondary outcomes

  1. OS

    Time frame: 1 years

    overall survival

  2. ORR

    Time frame: 3 months

    objective response rate

  3. DCR

    Time frame: 3 months

    disease control rate

  4. iORR

    Time frame: 3 months

    intracranial objective response rate

  5. iPFS

    Time frame: 3 months

    intracranial progression-free survival

Sponsors and collaborators

Lead sponsor

Peking University Third Hospital

Other

Collaborators

  • Huashan Hospital
  • Tianjin Medical University

Registry information

Official study title

Stereotactic Radiosurgery Combination With Anlotinib for Limited Brain Metastases in Non-small Cell Lung Cancer

Acronym: AnloSBRT

Important dates

Study start
2017
Primary completion
2021
Study completion
2021
First posted
Jun 3, 2021
Registry last updated
Jun 3, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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