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ACTIVE NOT RECRUITING
NCT04959500
PHASE2

Newly Diagnosed Glioblastoma

Sponsor: Sun Yat-sen University

View on ClinicalTrials.gov

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

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.

DRUG

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 (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