Newly Diagnosed Glioblastoma | NCT04959500

NCT04959500

Protocol Section

Identification Module

Results Section

No data available

No data is available for this block.

Annotation Section

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No data is available for this block.

Document Section

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No data is available for this block.

Derived Section

Miscellaneous Info Module

Status Module

Oversight Module

Design Module

Interventional Study Design

Biospecimen

No data available

No data is available for this block.

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Experimental group	Experimental	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.	Drug: Anlotinib Hydrochloride Radiation: Radiation Therapy Drug: Temozolomide
control group	Placebo Comparator	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.	Drug: Placebo Radiation: Radiation Therapy Drug: Temozolomide

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Anlotinib Hydrochloride	Drug	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.

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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.	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 Outcomes

Measure	Description	Time Frame
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.	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

Eligibility Module

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.

Facility	Status	City	State	ZIP	Country	Contacts
The First Affiliated Hospital of Bengbu Medical College		Bengbu	Anhui	233004	China
Beijing TianTan Hospital,Capital Medical University

ID	Term
D011878	Radiotherapy
D000077204	Temozolomide