Newly Diagnosed Glioblastoma

Sponsor

Sun Yat-sen University (Other)

Overall Status

Recruiting

CT.gov ID

NCT04959500

Collaborator

(none)

150

Enrollment

Locations

Arms

28.7

Anticipated Duration (Months)

7.1

Patients Per Site

0.2

Patients Per Site Per Month

Study Details

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

Condition or Disease	Intervention/Treatment	Phase
Glioblastoma	Drug: Anlotinib Hydrochloride Drug: Placebo Radiation: Radiation Therapy Drug: Temozolomide	Phase 2

Study Design

Study Type:

Interventional

Anticipated Enrollment :

150 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Primary Purpose:

Treatment

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

Actual Study Start Date :

Jun 10, 2021

Anticipated Primary Completion Date :

Oct 31, 2023

Anticipated Study Completion Date :

Oct 31, 2023

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Experimental group 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 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. 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.
Placebo Comparator: control group 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 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.

Arm

Intervention/Treatment

Experimental: Experimental group

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

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.

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.

Placebo Comparator: control group

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

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

Outcome Measures

Primary Outcome Measures

Progression Free Survival (PFS) assessed by IRC [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]
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) [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]
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) [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]
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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 75 Years

Sexes Eligible for Study:

All

Accepts 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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	The First Affiliated Hospital of Bengbu Medical College	Bengbu	Anhui	China	233004
2	Beijing TianTan Hospital,Capital Medical University	Beijing	Beijing Province	China	100070
3	The Sixth Madical Center of PLA General Hospital	Beijing	Beijing	China	100142
4	The General Hospital of the People's Liberation Army (PLAGH)	Beijing	Beijing	China	100853
5	Chongqing University Cancer Hospital	Chongqing	Chongqing Province	China	400000
6	Fujian Provincial Cancer Hospital	Fuzhou	Fujian	China	350014
7	Lanzhou University Second Hospital	Lanzhou	Gansu	China	730000
8	The First Hospital of Lanzhou University	Lanzhou	Gansu	China	730000
9	Sun Yat-sen University Cancer Center	Guangzhou	Guangdong	China	510060
10	Shenzhen People's Hospital	Shenzhen	Guangdong	China	518000
11	The Fifth Affiliated Hospital Sun Yat-sen University	Zhuhai	Guangdong	China	519000
12	The affiliated hospital of xuzhou medical university	Xuzhou	Jiangsu	China	221000
13	The First Affiliated Hospital of NanChang University	Nanchang	Jiangxi	China	330006
14	Jiangxi Cancer Hospital	Nanchang	Jiangxi	China	330029
15	Gansu Provincial Hospital	Gansu	Lanzhou Province	China	730000
16	Liaoning Cancer Hospital & Institute	Shenyang	Liaoning	China	110042
17	Fudan University shabghai cancer center	Shanghai	Shanghai	China	200433
18	The Second Affiliated Hospital of PLA Air Force Medical University	Xian	Shanxi	China	710000
19	West China Hospital，Sichuan University	Chengdu	Sichuan	China	610041
20	Tianjin Medical University General Hospital	Tianjin	Tianjin	China	300052
21	Zhejiang Cancer Hospital	Hangzhou	Zhejiang	China	310000

Sponsors and Collaborators

Sun Yat-sen University

Investigators

Principal Investigator: Zhongping Chen, Doctor, Sun Yat-sen University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Zhongping Chen, clinical professor, Sun Yat-sen University

ClinicalTrials.gov Identifier:

NCT04959500

Other Study ID Numbers:

ALTN-Ⅱ-01

First Posted:

Jul 13, 2021

Last Update Posted:

Jul 13, 2021

Last Verified:

Jul 1, 2021

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Glioblastoma

Temozolomide

Study Results

No Results Posted as of Jul 13, 2021