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Newly Diagnosed Glioblastoma

Primary Purpose

Glioblastoma

Status
Recruiting
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
Anlotinib Hydrochloride
Placebo
Radiation Therapy
Temozolomide
Sponsored by
Sun Yat-sen University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Glioblastoma

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Understood and Signed an informed consent form., with good compliance
  • Age: 18-75 years old；.Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2；Life expectancy of at least 3 months.
  • Glioblastoma confirmed by histology ;
  • Random time is 4-6 weeks from the last operation , and the investigator judges that the surgical wound has healed well;
  • Within 5 days before administration, the dosage of corticosteroids was stable or gradually decreased;
  • Male or female subjects should agree to use an adequate method of contraception starting with the first dose of study therapy through 6 months after the last dose of study ；Not Pregnant or breastfeeding women,Pregnancy before pregnancy screening, the women who blood / urine results were positivetherapy.

Exclusion Criteria:

  • Have previously received systemic radiotherapy and chemotherapy for GBM;
  • IDH1/2 mutations are present
  • Contraindicated for MRI examination
  • The tumor only occurs in the brain stem
  • Radiologically obvious diffuse meningeal dissemination
  • Imaging shows that the tumor has invaded the periphery of important blood vessels or the investigator judges that the tumor is very likely to invade important blood vessels and cause fatal hemorrhage, cerebrovascular malformations or other bleeding tendency during the subsequent study period;
  • Patients with arterial or venous thromboembolic events occurred within 6 months, such as cerebrovascular accident , deep vein thrombosis and pulmonary embolism；
  • Other malignant tumors have occurred or are currently present at the same time within 3 years.
  • There are many factors that affect oral medications ;
  • Received anti-tumor Chinese patent medicine which were approved by NMPA Within 2 weeks before the start of the study.
  • A clear history of neurological or psychiatric diseases, moderate or higher epilepsy , moderate or higher aphasia or dementia
  • Participated in other anti-tumor drug clinical trials within 4 weeks before grouping;
  • Other conditions which are not fit for this study assessed by investigator.

Sites / Locations

  • The First Affiliated Hospital of Bengbu Medical College
  • Beijing TianTan Hospital,Capital Medical University
  • The Sixth Madical Center of PLA General Hospital
  • The General Hospital of the People's Liberation Army (PLAGH)
  • Chongqing University Cancer Hospital
  • Fujian Provincial Cancer Hospital
  • Lanzhou University Second Hospital
  • The First Hospital of Lanzhou University
  • Sun Yat-sen University Cancer CenterRecruiting
  • Shenzhen People's Hospital
  • The Fifth Affiliated Hospital Sun Yat-sen University
  • The affiliated hospital of xuzhou medical university
  • The First Affiliated Hospital of NanChang University
  • Jiangxi Cancer Hospital
  • Gansu Provincial Hospital
  • Liaoning Cancer Hospital & Institute
  • Fudan University shabghai cancer center
  • The Second Affiliated Hospital of PLA Air Force Medical University
  • West China Hospital，Sichuan University
  • Tianjin Medical University General Hospital
  • Zhejiang Cancer Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Experimental group

control group

Arm Description

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 10 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.

Experimental: Radiation therapy, Temozolomide and Placebo Patients will receive standard radiation therapy plus temozolomide (Stupp regimen). Placebo will be given with a daily dose of 0 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.

Outcomes

Primary Outcome Measures

Progression Free Survival (PFS) assessed by IRC
PFS was defined as the time from the date of study enrollment to the date of the first of the following events: objective disease progression or death due to any cause.

Secondary Outcome Measures

The progression free survival (PFS)
PFS was defined as the time from the date of study enrollment to the date of the first of the following events: objective disease progression or death due to any cause.
Overall survival (OS)
OS was defined as the time from the date of study enrollment to the date of death due to any cause. Survival time was censored at the date of last contact for patients who were still alive or lost to follow-up.

Full Information

First Posted
June 23, 2021
Last Updated
July 12, 2021
Sponsor
Sun Yat-sen University
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1. Study Identification

Unique Protocol Identification Number
NCT04959500
Brief Title
Newly Diagnosed Glioblastoma
Official Title
Addition of Anlotinib Hydrochloride to the Stupp Regimen Versus the Stupp Regimen Alone for Newly Diagnosed Glioblastoma: A Randomized Double-blind Multicenter Prospective Phase II Study
Study Type
Interventional

2. Study Status

Record Verification Date
July 2021
Overall Recruitment Status
Recruiting
Study Start Date
June 10, 2021 (Actual)
Primary Completion Date
October 31, 2023 (Anticipated)
Study Completion Date
October 31, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Sun Yat-sen University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief Summary
Addition of Anlotinib Hydrochloride to the Stupp Regimen Versus the Stupp Regimen Alone for Newly Diagnosed Glioblastoma.Take PFS as the main evaluation index, the purpose is to evaluate its effectiveness

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Glioblastoma

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
150 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Experimental group
Arm Type
Experimental
Arm Description
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 10 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.
Arm Title
control group
Arm Type
Placebo Comparator
Arm Description
Experimental: Radiation therapy, Temozolomide and Placebo Patients will receive standard radiation therapy plus temozolomide (Stupp regimen). Placebo will be given with a daily dose of 0 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.
Intervention Type
Drug
Intervention Name(s)
Anlotinib Hydrochloride
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Drug: Placebo Placebo 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.
Intervention Type
Radiation
Intervention Name(s)
Radiation Therapy
Intervention Description
Radiation: Radiation therapy Radiation therapy will be delivered in daily fractions of 1.8-2.0 Gy given 5 days a week for a total of 54-60 Gy.
Intervention Type
Drug
Intervention Name(s)
Temozolomide
Intervention Description
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 200 mg/m2 for 5 days of a 28-day cycle for a total of 6 cycles.
Primary Outcome Measure Information:
Title
Progression Free Survival (PFS) assessed by IRC
Description
PFS was defined as the time from the date of study enrollment to the date of the first of the following events: objective disease progression or death due to any cause.
Time Frame
From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 24 months
Secondary Outcome Measure Information:
Title
The progression free survival (PFS)
Description
PFS was defined as the time from the date of study enrollment to the date of the first of the following events: objective disease progression or death due to any cause.
Time Frame
From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 24 months
Title
Overall survival (OS)
Description
OS was defined as the time from the date of study enrollment to the date of death due to any cause. Survival time was censored at the date of last contact for patients who were still alive or lost to follow-up.
Time Frame
From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 24 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Understood and Signed an informed consent form., with good compliance Age: 18-75 years old；.Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2；Life expectancy of at least 3 months. Glioblastoma confirmed by histology ; Random time is 4-6 weeks from the last operation , and the investigator judges that the surgical wound has healed well; Within 5 days before administration, the dosage of corticosteroids was stable or gradually decreased; Male or female subjects should agree to use an adequate method of contraception starting with the first dose of study therapy through 6 months after the last dose of study ；Not Pregnant or breastfeeding women,Pregnancy before pregnancy screening, the women who blood / urine results were positivetherapy. Exclusion Criteria: Have previously received systemic radiotherapy and chemotherapy for GBM; IDH1/2 mutations are present Contraindicated for MRI examination The tumor only occurs in the brain stem Radiologically obvious diffuse meningeal dissemination Imaging shows that the tumor has invaded the periphery of important blood vessels or the investigator judges that the tumor is very likely to invade important blood vessels and cause fatal hemorrhage, cerebrovascular malformations or other bleeding tendency during the subsequent study period; Patients with arterial or venous thromboembolic events occurred within 6 months, such as cerebrovascular accident , deep vein thrombosis and pulmonary embolism； Other malignant tumors have occurred or are currently present at the same time within 3 years. There are many factors that affect oral medications ; Received anti-tumor Chinese patent medicine which were approved by NMPA Within 2 weeks before the start of the study. A clear history of neurological or psychiatric diseases, moderate or higher epilepsy , moderate or higher aphasia or dementia Participated in other anti-tumor drug clinical trials within 4 weeks before grouping; Other conditions which are not fit for this study assessed by investigator.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Zhongping Chen, Doctor
Phone
13500002457
Email
chenzhp@sysucc.org.cn
First Name & Middle Initial & Last Name or Official Title & Degree
Yuanyuan Chen, Doctor
Phone
13738103808
Email
chenyy@zjcc.org.cn
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Zhongping Chen, Doctor
Organizational Affiliation
Sun Yat-sen University
Official's Role
Principal Investigator
Facility Information:
Facility Name
The First Affiliated Hospital of Bengbu Medical College
City
Bengbu
State/Province
Anhui
ZIP/Postal Code
233004
Country
China
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Hao Jiang, Master
Phone
13500568891
Email
jianghao1223@163.com
Facility Name
Beijing TianTan Hospital,Capital Medical University
City
Beijing
State/Province
Beijing Province
ZIP/Postal Code
100070
Country
China
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Song Lin, Doctor
Phone
1380112769
Email
linsong2005@126.com
Facility Name
The Sixth Madical Center of PLA General Hospital
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100142
Country
China
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Wei Zheng, Doctor
Phone
18600317539
Email
navyzw@163.com
Facility Name
The General Hospital of the People's Liberation Army (PLAGH)
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100853
Country
China
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Longsheng Pan, Doctor
Phone
1390136562
Email
panls301@163.com
First Name & Middle Initial & Last Name & Degree
Shiyu Feng, Undergraduate
Phone
15011288969
Email
fsy72123@163.com
Facility Name
Chongqing University Cancer Hospital
City
Chongqing
State/Province
Chongqing Province
ZIP/Postal Code
400000
Country
China
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Run Cai, Doctor
Phone
13072341313
Email
cairun0519@qq.com
Facility Name
Fujian Provincial Cancer Hospital
City
Fuzhou
State/Province
Fujian
ZIP/Postal Code
350014
Country
China
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Junxin Wu, Doctor
Phone
13635293859
Email
junxinwu@126.com
Facility Name
Lanzhou University Second Hospital
City
Lanzhou
State/Province
Gansu
ZIP/Postal Code
730000
Country
China
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Pengfei Sun, Doctor
Phone
13919485464
Email
sunpengfeiby@163.com
Facility Name
The First Hospital of Lanzhou University
City
Lanzhou
State/Province
Gansu
ZIP/Postal Code
730000
Country
China
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Juntao Ran, Doctor
Phone
13893399585
Email
ranjt@lzu.edu.cn
Facility Name
Sun Yat-sen University Cancer Center
City
Guangzhou
State/Province
Guangdong
ZIP/Postal Code
510060
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Zhongping Chen, Doctor
Phone
13500002457
Email
chenzhp@sysucc.org.cn
First Name & Middle Initial & Last Name & Degree
Yuanyuan Chen, Doctor
Phone
13738103808
Email
chenyy@zjcc.org.cn
Facility Name
Shenzhen People's Hospital
City
Shenzhen
State/Province
Guangdong
ZIP/Postal Code
518000
Country
China
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Xianming Li, Doctor
Phone
13502869369
Email
lxm1828@hotmail.com
Facility Name
The Fifth Affiliated Hospital Sun Yat-sen University
City
Zhuhai
State/Province
Guangdong
ZIP/Postal Code
519000
Country
China
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Zhigang Liu, Doctor
Phone
18627585860
Email
Zhigangliu1983@hotmail.com
Facility Name
The affiliated hospital of xuzhou medical university
City
Xuzhou
State/Province
Jiangsu
ZIP/Postal Code
221000
Country
China
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Guihong Liu, Master
Phone
18052268720
Email
2995181541@qq.com
Facility Name
The First Affiliated Hospital of NanChang University
City
Nanchang
State/Province
Jiangxi
ZIP/Postal Code
330006
Country
China
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Meihua Li, Doctor
Phone
13970052318
Email
Limeihua2000@sina.com
Facility Name
Jiangxi Cancer Hospital
City
Nanchang
State/Province
Jiangxi
ZIP/Postal Code
330029
Country
China
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yiqiang Tang, Master
Phone
13607916372
Email
Johnytangyq@163.com
Facility Name
Gansu Provincial Hospital
City
Gansu
State/Province
Lanzhou Province
ZIP/Postal Code
730000
Country
China
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Hongyi Cai, Master
Phone
13309492018
Email
gschy333@163.com
Facility Name
Liaoning Cancer Hospital & Institute
City
Shenyang
State/Province
Liaoning
ZIP/Postal Code
110042
Country
China
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Haozhe Pu, Doctor
Phone
13940070166
Email
pzpy@163.com
Facility Name
Fudan University shabghai cancer center
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
200433
Country
China
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Xueguan Lu, Doctor
Phone
18121199382
Email
luxueguan@163.com
Facility Name
The Second Affiliated Hospital of PLA Air Force Medical University
City
Xian
State/Province
Shanxi
ZIP/Postal Code
710000
Country
China
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Liang Wang, Doctor
Phone
13319232049
Email
Doctorwangliang@163.com
Facility Name
West China Hospital，Sichuan University
City
Chengdu
State/Province
Sichuan
ZIP/Postal Code
610041
Country
China
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yanhui Liu, Doctor
Phone
18980601509
Email
827005432@qq.com
Facility Name
Tianjin Medical University General Hospital
City
Tianjin
State/Province
Tianjin
ZIP/Postal Code
300052
Country
China
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Xuejun Yang, Doctor
Phone
13011329950
Email
ydenny@126.com
Facility Name
Zhejiang Cancer Hospital
City
Hangzhou
State/Province
Zhejiang
ZIP/Postal Code
310000
Country
China
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yonghong Hua, Doctor
Phone
13858032047
Email
yonghonghua@163.com

12. IPD Sharing Statement

Learn more about this trial

Newly Diagnosed Glioblastoma

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