Stereotactic Radiosurgery Combination With Anlotinib for Limited Brain Metastases With Perilesional Edema in NSCLC (Rvision-001)

  • STATUS
    Recruiting
  • End date
    Dec 15, 2022
  • participants needed
    50
  • sponsor
    Peking University Third Hospital
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Updated on 1 March 2022
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Summary

The purpose of this study is to determine whether stereotactic radiosurgery combination with Anlotinib is safe, effective in the treatment of limited brain metastases with Perilesional edema in non-small cell lung cancer.

Description

The purpose of this study is to determine whether stereotactic radiosurgery combination with Anlotinib is safe, effective in the treatment of limited brain metastases with perilesional edema in non-small cell lung cancer. The sample size is 50. Patients start to take Anlotinib 1 week before the MRI-based simulation12mg/d QDday1~14, day22~36.Edema index will be used to evaluate the effectiveness of Anlotinib. The "Edema index (EI)" is calculated per the equation of "edema index= (peri-tumoral edema volume+ tumor volume)/tumor volume.

Details
Condition Stereotactic Body Radiation Therapy
Treatment Stereotactic Radiosurgery, Anlotinib
Clinical Study IdentifierNCT04147728
SponsorPeking University Third Hospital
Last Modified on1 March 2022

Eligibility

 Yes No Not Sure

Inclusion Criteria

Patients voluntarily participate in this study, signed informed consent
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) 1.510e9/L; iii) platelet (PLT) 8010e9/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
Female patients should agree to use contraceptives during and within 6 months after the study

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
Patients who still can't tolerate SRS after anlotinib treatment, even after adding mannitol, and have to receive steroid treatment
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