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Addition of Anlotinib Hydrochloride to the Stupp Regimen Versus the Stupp Regimen Alone for Newly Diagnosed Glioblastoma

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ClinicalTrials.gov Identifier: NCT04157478
Recruitment Status : Not yet recruiting
First Posted : November 8, 2019
Last Update Posted : November 11, 2019
Sponsor:
Collaborators:
First Affiliated Hospital of Guangxi Medical University
Cancer Hospital of Guangxi Medical University
Liuzhou Worker's Hospital
Nanxishan Hospital
Liuzhou People's Hospital
Affiliated Hospital of Guilin University
Information provided by (Responsible Party):
Heming Lu, People's Hospital of Guangxi

Tracking Information
First Submitted Date  ICMJE November 6, 2019
First Posted Date  ICMJE November 8, 2019
Last Update Posted Date November 11, 2019
Estimated Study Start Date  ICMJE January 2020
Estimated Primary Completion Date December 2022   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: November 6, 2019)
Progression-free survival [ Time Frame: 3 years ]
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT04157478 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: November 6, 2019)
  • Overall survival [ Time Frame: 3 years ]
  • Objective response rate [ Time Frame: 3 years ]
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 Addition of Anlotinib Hydrochloride to the Stupp Regimen Versus the Stupp Regimen Alone for Newly Diagnosed Glioblastoma
Official Title  ICMJE Addition of Anlotinib Hydrochloride to the Stupp Regimen Versus the Stupp Regimen Alone for Newly Diagnosed Glioblastoma: A Randomized Multicenter Prospective Phase II Study
Brief Summary For patients with glioblastoma,postoperative radiotherapy combined with concurrent and adjuvant temozolomide (Stupp regimen) has long been considered a standard treatment approach.The treatment outcomes, however, are still dismal, with a median overall survival time of 8-12 months. As a novel small molecule multi-target tyrosine kinase inhibitor, anlotinib hydrochloride has been found to be able to inhibit both tumor angiogenesis and cell growth.Previous studies on recurrent glioblastoma have demonstrated its effectiveness in tumor control with manageable toxicities. The current study is designed to evaluate the efficacy and feasibility of the additional anlotinib hydrochloride to the Stupp regimen for newly diagnosed glioblastoma.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Glioblastoma
Intervention  ICMJE
  • Drug: Anlotinib Hydrochloride
    Anlotinib hydrochloride will be given with a daily dose of 12 mg for 14 days of a 21-day cycle up to 2 cycles, initiated on the first day of radiation therapy and followed by adjuvant treatment with the same dosing schedule until patients have disease progression or intolerable toxicities.
  • Radiation: Radiation therapy
    Radiation therapy will be delivered in daily fractions of 2 Gy given 5 days a week for a total of 60 Gy.
  • Drug: Temozolomide
    Temozolomide will be administered at a daily dose of 75 mg/m2 until the completion of radiation therapy. Four weeks after the completion of radiation therapy, patients will be given with adjuvant chemotherapy with temozolomide at a dose of 150-200 mg/m2 for 5 days of a 28-day cycle for a total of 6 cycles.
Study Arms  ICMJE
  • Experimental: Radiation therapy, Temozolomide and anlotinib
    Patients will receive standard radiation therapy plus temozolomide (Stupp regimen). Anlotinib hydrochloride will be given with a daily dose of 12 mg for 14 days of a 21-day cycle up to 2 cycles, initiated on the first day of radiation therapy and followed by adjuvant treatment with the same dosing schedule until patients have disease progression or intolerable toxicities.
    Interventions:
    • Drug: Anlotinib Hydrochloride
    • Radiation: Radiation therapy
    • Drug: Temozolomide
  • Active Comparator: Radiation therapy and temozolomide
    Patients will receive standard radiation therapy plus temozolomide (Stupp regimen).
    Interventions:
    • Radiation: Radiation therapy
    • Drug: Temozolomide
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 Not yet recruiting
Estimated Enrollment  ICMJE
 (submitted: November 6, 2019)
464
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 2024
Estimated Primary Completion Date December 2022   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Newly diagnosed and histological proven glioblastoma
  • Complete gross resection or subtotal resection
  • Eastern Cooperative Oncology Group (ECOG) performance status of 0-2
  • Adequate bone marrow, liver and renal function
  • Written informed consent

Exclusion Criteria:

  • Meningeal carcinomatosis or spinal compression
  • Patients who have previously received chemotherapy, targeted therapy, or anti-angiogenesis
  • Active, known, or suspected autoimmune disease
  • Severe allergy to anlotinib or temozolomide
  • Patient having acute hepatitis virus infection, active tuberculosis, or other acute infectious diseases
  • Uncontrolled mental disorders
  • High risk of bleeding
  • Severe cardiovascular disease: myocardial ischemia or myocardial infarction above grade II, poorly controlled arrhythmias (including men with QTc interval ≥ 450 ms, women ≥ 470 ms), according to NYHA criteria; grades III to IV Insufficient function, or cardiac color Doppler ultrasound examination indicates left ventricular ejection fraction (LVEF) <50%
  • Contraindicated for MRI examination
  • Recipient of live vaccine prior to the first dose of anlotinib
  • Ready for or previously received organ transplantation
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 75 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Heming Lu, MD 86-771-2186-504 gxheminglu@sina.com
Listed Location Countries  ICMJE China
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04157478
Other Study ID Numbers  ICMJE GXPH-19001
Has Data Monitoring Committee Yes
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 Not Provided
Responsible Party Heming Lu, People's Hospital of Guangxi
Study Sponsor  ICMJE People's Hospital of Guangxi
Collaborators  ICMJE
  • First Affiliated Hospital of Guangxi Medical University
  • Cancer Hospital of Guangxi Medical University
  • Liuzhou Worker's Hospital
  • Nanxishan Hospital
  • Liuzhou People's Hospital
  • Affiliated Hospital of Guilin University
Investigators  ICMJE Not Provided
PRS Account People's Hospital of Guangxi
Verification Date November 2019

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