Addition of Anlotinib Hydrochloride to the Stupp Regimen Versus the Stupp Regimen Alone for Newly Diagnosed Glioblastoma
1 other identifier
interventional
464
1 country
7
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Jan 2020
Longer than P75 for phase_2
7 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 6, 2019
CompletedFirst Posted
Study publicly available on registry
November 8, 2019
CompletedStudy Start
First participant enrolled
January 1, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2024
CompletedNovember 12, 2019
November 1, 2019
2.9 years
November 6, 2019
November 7, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Progression-free survival
3 years
Secondary Outcomes (2)
Overall survival
3 years
Objective response rate
3 years
Study Arms (2)
Radiation therapy, Temozolomide and anlotinib
EXPERIMENTALPatients 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.
Radiation therapy and temozolomide
ACTIVE COMPARATORPatients will receive standard radiation therapy plus temozolomide (Stupp regimen).
Interventions
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 therapy will be delivered in daily fractions of 2 Gy given 5 days a week for a total of 60 Gy.
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.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- People's Hospital of Guangxi Zhuang Autonomous Regionlead
- First Affiliated Hospital of Guangxi Medical Universitycollaborator
- Cancer Hospital of Guangxi Medical Universitycollaborator
- Liuzhou Workers' Hospitalcollaborator
- Nanxishan Hospitalcollaborator
- LiuZhou People's Hospitalcollaborator
- Affiliated Hospital of Guilin Universitycollaborator
Study Sites (7)
Nanxishan Hospital of Guangxi Zhuang Autonomous Region
Guilin, Guangxi, 541002, China
Liuzhou Worker's Hospital
Liuchow, Guangxi, 545005, China
Liuzhou People's Hospital
Liuchow, Guangxi, 545006, China
Affiliated Hospital of Guangxi Medical University
Nanning, Guangxi, 530021, China
Affiliated Tumor Hospital of Guangxi Medical University
Nanning, Guangxi, 530021, China
People's Hospital of Guangxi Zhuang Autonomous Region
Nanning, Guangxi, 530021, China
Yulin First Hospital
Yulin, Guangxi, 537000, China
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor
Study Record Dates
First Submitted
November 6, 2019
First Posted
November 8, 2019
Study Start
January 1, 2020
Primary Completion
December 1, 2022
Study Completion
December 1, 2024
Last Updated
November 12, 2019
Record last verified: 2019-11