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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
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

Tracking Information
First Submitted Date  ICMJE October 6, 2019
First Posted Date  ICMJE October 8, 2019
Last Update Posted Date October 8, 2019
Actual Study Start Date  ICMJE January 15, 2019
Estimated Primary Completion Date June 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 6, 2019)
PFS [ Time Frame: from enrollment to progression or death (for any reason),assessed up to 18months ]
Progression-Free Survival
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: October 6, 2019)
  • OS [ Time Frame: from enrollment to death (for any reason).assessed up to 24 months ]
    Overall Survival
  • 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
  • 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.
  • 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).
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Pilot Study of Anlotinib With STUPP Regimen for Patients With Newly Diagnosed Glioblastoma
Official Title  ICMJE Pilot Study of Anlotinib in Combination With STUPP Regimen for Treatment of Patients With Newly Diagnosed Glioblastoma
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Phase 2
Study Design  ICMJE Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Glioblastoma
Intervention  ICMJE
  • Biological: Anlotinib
    Anlotinib With STUPP Regimen
  • Drug: Temozolomide Capsule
    Anlotinib With STUPP Regimen
Study Arms  ICMJE Experimental: Arm
Experimental: arm Biological: Anlotinib Drug: Temozolomide Radiotherapy:2.0 Gy/fraction ×30 fractions Monday to Friday total dose of 60Gy
Interventions:
  • Biological: Anlotinib
  • Drug: Temozolomide Capsule
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: October 6, 2019)
20
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE May 2021
Estimated Primary Completion Date June 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 70 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Chen Yuanyuan, MD 08613738103808 chenyy@zjcc.org.cn
Listed Location Countries  ICMJE China
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04119674
Other Study ID Numbers  ICMJE GBM-AS
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Zhejiang Cancer Hospital
Study Sponsor  ICMJE Zhejiang Cancer Hospital
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Chen Ming Zhejiang Cancer Hospital
PRS Account Zhejiang Cancer Hospital
Verification Date January 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP