Newly Diagnosed Glioblastoma

Glioblastoma Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04959500
• Other study ID #: ALTN-?-01
• Status: Recruiting
• Phase: Phase 2
• Start date: June 10, 2021
• Est. completion date: October 31, 2023

Study information

• Verified date: July 2021
• Source: Sun Yat-sen University
• Contact: Zhongping Chen, Doctor
• Phone: 13500002457
• Email: chenzhp[@]sysucc.org.cn
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 150
• Est. completion date: October 31, 2023
• Est. primary completion date: October 31, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Glioblastoma

Intervention

Drug:
• Anlotinib Hydrochloride
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.
• Placebo
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.

Radiation:
• Radiation Therapy
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.

Drug:
• Temozolomide
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.

Locations

Country	Name	City	State
China	Beijing TianTan Hospital,Capital Medical University	Beijing	Beijing Province
China	The General Hospital of the People's Liberation Army (PLAGH)	Beijing	Beijing
China	The Sixth Madical Center of PLA General Hospital	Beijing	Beijing
China	The First Affiliated Hospital of Bengbu Medical College	Bengbu	Anhui
China	West China Hospital,Sichuan University	Chengdu	Sichuan
China	Chongqing University Cancer Hospital	Chongqing	Chongqing Province
China	Fujian Provincial Cancer Hospital	Fuzhou	Fujian
China	Gansu Provincial Hospital	Gansu	Lanzhou Province
China	Sun Yat-sen University Cancer Center	Guangzhou	Guangdong
China	Zhejiang Cancer Hospital	Hangzhou	Zhejiang
China	Lanzhou University Second Hospital	Lanzhou	Gansu
China	The First Hospital of Lanzhou University	Lanzhou	Gansu
China	Jiangxi Cancer Hospital	Nanchang	Jiangxi
China	The First Affiliated Hospital of NanChang University	Nanchang	Jiangxi
China	Fudan University shabghai cancer center	Shanghai	Shanghai
China	Liaoning Cancer Hospital & Institute	Shenyang	Liaoning
China	Shenzhen People's Hospital	Shenzhen	Guangdong
China	Tianjin Medical University General Hospital	Tianjin	Tianjin
China	The Second Affiliated Hospital of PLA Air Force Medical University	Xian	Shanxi
China	The affiliated hospital of xuzhou medical university	Xuzhou	Jiangsu
China	The Fifth Affiliated Hospital Sun Yat-sen University	Zhuhai	Guangdong

Sponsors (1)

Lead Sponsor	Collaborator
Sun Yat-sen University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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.	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