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Pilot Study of Anlotinib With STUPP Regimen for Patients With Newly Diagnosed Glioblastoma

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ClinicalTrials.gov Identifier: NCT04119674
Recruitment Status : Recruiting
First Posted : October 8, 2019
Last Update Posted : October 8, 2019
Sponsor:
Information provided by (Responsible Party):
Zhejiang Cancer Hospital

Brief Summary:
The purpose of this study is to test the the efficacy and safety of Anlotinib in combination with STUPP regimen for patients with newly diagnosed glioblastoma.

Condition or disease Intervention/treatment Phase
Glioblastoma Biological: Anlotinib Drug: Temozolomide Capsule Phase 1 Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Pilot Study of Anlotinib in Combination With STUPP Regimen for Treatment of Patients With Newly Diagnosed Glioblastoma
Actual Study Start Date : January 15, 2019
Estimated Primary Completion Date : June 2020
Estimated Study Completion Date : May 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Arm
Experimental: arm Biological: Anlotinib Drug: Temozolomide Radiotherapy:2.0 Gy/fraction ×30 fractions Monday to Friday total dose of 60Gy
Biological: Anlotinib
Anlotinib With STUPP Regimen

Drug: Temozolomide Capsule
Anlotinib With STUPP Regimen




Primary Outcome Measures :
  1. PFS [ Time Frame: from enrollment to progression or death (for any reason),assessed up to 18months ]
    Progression-Free Survival


Secondary Outcome Measures :
  1. OS [ Time Frame: from enrollment to death (for any reason).assessed up to 24 months ]
    Overall Survival

  2. adverse event [ Time Frame: from enrollment to death (for any reason).assessed up to 24 months ]
    Adverse events are described in terms of CTC AE 5.0

  3. Health-related quality of life [ Time Frame: from enrollment to death (for any reason).assessed up to 24 months ]
    Health-related quality of life are measured by the EORTC-QL30/BN20.

  4. Neurocognitive function [ Time Frame: from enrollment to death (for any reason).assessed up to 24 months ]
    Neurocognitive function are measured by John-Hopkins adapted cognitive exam (ACE).



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

1.Histologically proven diagnosis of glioblastoma (WHO grade IV) 2.1.4-6 weeks after surgery and incision has healed 3.Patients with quantifiable target lesions according to RANO criteria 4.Aged 18-70 years 5.Karnofsky performance status ≥ 60 6.Corticosteroids doses has been stabilized or decreased within 5 days 7.No previous radiotherapy, chemotherapy, immunotherapy or biotherapy 8.Adequate bone marrow function: Hemoglobin ≥ 100g/L,Platelets ≥ 80×109/L,Absolute neutrophil count (ANC) ≥ 1.5×109/L 9.Adequate renal function: Serum creatinine ≤ 1.25 x UNL (upper normal limit) or creatinine clearance ≥ 60 ml/min 10.Adequate hepatic function: serum bilirubin ≤ 1.5 x UNL, AST and ALT ≤ 2.5 x UNL,ALP≤5x UNL 11.Adequate coagulation function: PT ≤ 5 seconds above the UNL, APTT≤ 5 seconds above the UNL 12.For females of child-bearing potential, negative serum pregnancy test within 14 days prior to registration. Women of childbearing potential and male participants must practice adequate contraception during participation in the study and within 8 weeks after the last administration of the drug 13.Subject is willing and able to comply with the protocol for the duration of the study including undergoing treatment and scheduled visits and examinations including follow up 14.Able to provide written informed consent

Exclusion Criteria:

  1. Recurrent malignant gliomas
  2. Prior invasive malignancy (except for non-melanomatous skin cancer or carcinoma in situ of cervix)
  3. Contraindication of radiotherapy and chemotherapy defined as follows: Acute bacterial or fungal infection,Unstable angina and/or congestive heart failure within the last 6 months,co-morbidity with immunosuppressive therapy
  4. Pregnant or lactating women
  5. women of childbearing potential and men who are sexually active and not willing/able to use medically acceptable forms of contraception
  6. Evidence of bleeding diathesis or coagulopathy
  7. Patients on anticoagulants for co-morbidity

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04119674


Contacts
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Contact: Chen Yuanyuan, MD 08613738103808 chenyy@zjcc.org.cn

Locations
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China, Zhejiang
Zhejiang cancer hospital Recruiting
Hangzhou, Zhejiang, China, 310022
Contact: Chen Ming, MD    0086-571-88122068      
Sponsors and Collaborators
Zhejiang Cancer Hospital
Investigators
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Principal Investigator: Chen Ming Zhejiang Cancer Hospital

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Responsible Party: Zhejiang Cancer Hospital
ClinicalTrials.gov Identifier: NCT04119674     History of Changes
Other Study ID Numbers: GBM-AS
First Posted: October 8, 2019    Key Record Dates
Last Update Posted: October 8, 2019
Last Verified: January 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Glioblastoma
Astrocytoma
Glioma
Neoplasms, Neuroepithelial
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms, Nerve Tissue
Temozolomide
Antineoplastic Agents, Alkylating
Alkylating Agents
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents