Stereotactic Radiosurgery Combination With Anlotinib for Limited Brain Metastases With Perilesional Edema in NSCLC

NCT04147728 | Unknown Phase 2 DMC

• 1 other identifier: Rvision-001
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Stereotactic Body Radiation Therapy

Outcome Measures

Primary Outcomes (1)

• EI

  Edema Index. The "Edema index (EI)" is calculated per the equation of "edema index= (peri-tumoral edema volume+ tumor volume)/tumor volume.

  1 month

Secondary Outcomes (7)

• PFS

  1 year

• OS

  1 year

• ORR

  3 months

• DCR

  3 months

• iORR

  3 months

Study Arms (1)

SRS Combination With Anlotinib

EXPERIMENTAL

Stereotactic Radiosurgery Combination With Anlotinib

Drug: Anlotinib; Radiation: Stereotactic Radiosurgery

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.

Also known as: Antiangiogenic agents

SRS Combination With Anlotinib

Stereotactic Radiosurgery RADIATION

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

SRS Combination With Anlotinib

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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:
• a) 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;
• Female patients should agree to use contraceptives during and within 6 months after the study.

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

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

RECRUITING

Related Publications (1)

• Zhuang H, Wang Y, Cheng C, Shi S. The efficacy of anlotinib instead of glucocorticoids for edema induced by brain metastases in NSCLC patients with anti-PD1/PDL-1 immunotherapy. Neuro Oncol. 2021 Jan 30;23(1):169-171. doi: 10.1093/neuonc/noaa236. No abstract available.

  PMID: 33294918 DERIVED

MeSH Terms

Interventions

anlotinib; Angiogenesis Inhibitors; Radiosurgery

Intervention Hierarchy (Ancestors)

Angiogenesis Modulating Agents; Growth Substances; Physiological Effects of Drugs; Pharmacologic Actions; Chemical Actions and Uses; Growth Inhibitors; Antineoplastic Agents; Therapeutic Uses; Radiotherapy; Therapeutics; Stereotaxic Techniques; Neurosurgical Procedures; Surgical Procedures, Operative; Investigative Techniques

Study Officials

• Hongqing Zhuang, doctor

  Peking University Third Hospital

  STUDY DIRECTOR

Central Study Contacts

Hongqing Zhuang, doctor

CONTACT

13051776232; hongqingzhuang@163.com

Yuxia Wang, doctor

CONTACT

15001292991; lily31415926@126.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 30, 2019
• First Posted: November 1, 2019
• Study Start: December 24, 2019
• Primary Completion: December 15, 2021
• Study Completion: December 15, 2022
• Last Updated: March 4, 2020

Record last verified: 2019-10

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)