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Newly Diagnosed Glioblastoma
Sponsor: Sun Yat-sen University
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
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
Key Details
Gender
All
Age Range
18 Years - 75 Years
Study Type
INTERVENTIONAL
Enrollment
150
Start Date
2021-07-21
Completion Date
2026-12-31
Last Updated
2026-01-02
Healthy Volunteers
No
Conditions
Interventions
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 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.
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 (22)
The First Affiliated Hospital of Bengbu Medical College
Bengbu, Anhui, China
Beijing TianTan Hospital,Capital Medical University
Beijing, Beijing Municipality, China
The Sixth Madical Center of PLA General Hospital
Beijing, Beijing Municipality, China
The General Hospital of the People's Liberation Army (PLAGH)
Beijing, Beijing Municipality, China
Chongqing University Cancer Hospital
Chongqing, Chongqing Municipality, China
Fujian Provincial Cancer Hospital
Fuzhou, Fujian, China
Lanzhou University Second Hospital
Lanzhou, Gansu, China
The First Hospital of Lanzhou University
Lanzhou, Gansu, China
Sun Yat-sen University Cancer Center
Guangzhou, Guangdong, China
Shenzhen People's Hospital
Shenzhen, Guangdong, China
The Fifth Affiliated Hospital Sun Yat-sen University
Zhuhai, Guangdong, China
Henan Cancer Hospital
Zhengzhou, Henan, China
The affiliated hospital of xuzhou medical university
Xuzhou, Jiangsu, China
The First Affiliated Hospital of NanChang University
Nanchang, Jiangxi, China
Jiangxi Cancer Hospital
Nanchang, Jiangxi, China
Gansu Provincial Hospital
Gansu, Lanzhou Province, China
Liaoning Cancer Hospital & Institute
Shenyang, Liaoning, China
Fudan University shabghai cancer center
Shanghai, Shanghai Municipality, China
The Second Affiliated Hospital of PLA Air Force Medical University
Xian, Shanxi, China
West China Hospital,Sichuan University
Chengdu, Sichuan, China
Tianjin Medical University General Hospital
Tianjin, Tianjin Municipality, China
Zhejiang Cancer Hospital
Hangzhou, Zhejiang, China