Back to results

Addition of Anlotinib Hydrochloride to the Stupp Regimen Versus the Stupp Regimen Alone for Newly Diagnosed Glioblastoma

Primary Purpose

Glioblastoma

Status

Not yet recruiting

Phase

Phase 2

Locations

China

Study Type

Interventional

Intervention

Anlotinib Hydrochloride

Radiation therapy

Temozolomide

About this trial

This is an interventional treatment trial for Glioblastoma focused on measuring Glioblastoma, Anlotinib hydrochloride, Stupp regimen, Temozolomide, Radiation therapy, Tyrosine kinase inhibitor

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Newly diagnosed and histological proven glioblastoma
Complete gross resection or subtotal resection
Eastern Cooperative Oncology Group (ECOG) performance status of 0-2
Adequate bone marrow, liver and renal function
Written informed consent

Exclusion Criteria:

Meningeal carcinomatosis or spinal compression
Patients who have previously received chemotherapy, targeted therapy, or anti-angiogenesis
Active, known, or suspected autoimmune disease
Severe allergy to anlotinib or temozolomide
Patient having acute hepatitis virus infection, active tuberculosis, or other acute infectious diseases
Uncontrolled mental disorders
High risk of bleeding
Severe cardiovascular disease: myocardial ischemia or myocardial infarction above grade II, poorly controlled arrhythmias (including men with QTc interval ≥ 450 ms, women ≥ 470 ms), according to NYHA criteria; grades III to IV Insufficient function, or cardiac color Doppler ultrasound examination indicates left ventricular ejection fraction (LVEF) <50%
Contraindicated for MRI examination
Recipient of live vaccine prior to the first dose of anlotinib
Ready for or previously received organ transplantation

Sites / Locations

Nanxishan Hospital of Guangxi Zhuang Autonomous Region
Liuzhou Worker's Hospital
Liuzhou People's Hospital
Affiliated Hospital of Guangxi Medical University
Affiliated Tumor Hospital of Guangxi Medical University
People's Hospital of Guangxi Zhuang Autonomous Region
Yulin First Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Radiation therapy, Temozolomide and anlotinib

Radiation therapy and temozolomide

Arm Description

Patients will receive standard radiation therapy plus temozolomide (Stupp regimen). 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.

Patients will receive standard radiation therapy plus temozolomide (Stupp regimen).

Outcomes

Primary Outcome Measures

Progression-free survival

Secondary Outcome Measures

Overall survival

Objective response rate

Full Information

NCT ID

NCT04157478

First Posted

November 6, 2019

Last Updated

November 7, 2019

Sponsor

People's Hospital of Guangxi

Collaborators

First Affiliated Hospital of Guangxi Medical University, Cancer Hospital of Guangxi Medical University, Liuzhou Workers Hospital, Nanxishan Hospital, LiuZhou People's Hospital, Affiliated Hospital of Guilin University

1. Study Identification

Unique Protocol Identification Number

NCT04157478

Brief Title

Addition of Anlotinib Hydrochloride to the Stupp Regimen Versus the Stupp Regimen Alone for Newly Diagnosed Glioblastoma

Official Title

Addition of Anlotinib Hydrochloride to the Stupp Regimen Versus the Stupp Regimen Alone for Newly Diagnosed Glioblastoma: A Randomized Multicenter Prospective Phase II Study

Study Type

Interventional

2. Study Status

Record Verification Date

November 2019

Overall Recruitment Status

Not yet recruiting

Study Start Date

January 2020 (Anticipated)

Primary Completion Date

December 2022 (Anticipated)

Study Completion Date

December 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

People's Hospital of Guangxi

Collaborators

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

For patients with glioblastoma,postoperative radiotherapy combined with concurrent and adjuvant temozolomide (Stupp regimen) has long been considered a standard treatment approach.The treatment outcomes, however, are still dismal, with a median overall survival time of 8-12 months. As a novel small molecule multi-target tyrosine kinase inhibitor, anlotinib hydrochloride has been found to be able to inhibit both tumor angiogenesis and cell growth.Previous studies on recurrent glioblastoma have demonstrated its effectiveness in tumor control with manageable toxicities. The current study is designed to evaluate the efficacy and feasibility of the additional anlotinib hydrochloride to the Stupp regimen for newly diagnosed glioblastoma.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Glioblastoma

Keywords

Glioblastoma, Anlotinib hydrochloride, Stupp regimen, Temozolomide, Radiation therapy, Tyrosine kinase inhibitor

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

464 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Radiation therapy, Temozolomide and anlotinib

Arm Type

Experimental

Arm Description

Arm Title

Radiation therapy and temozolomide

Arm Type

Active Comparator

Arm Description

Patients will receive standard radiation therapy plus temozolomide (Stupp regimen).

Intervention Type

Drug

Intervention Name(s)

Anlotinib Hydrochloride

Intervention Description

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.

Intervention Type

Radiation

Intervention Name(s)

Radiation therapy

Intervention Description

Radiation therapy will be delivered in daily fractions of 2 Gy given 5 days a week for a total of 60 Gy.

Intervention Type

Drug

Intervention Name(s)

Temozolomide

Intervention Description

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 150-200 mg/m2 for 5 days of a 28-day cycle for a total of 6 cycles.

Primary Outcome Measure Information:

Title

Progression-free survival

Time Frame

3 years

Secondary Outcome Measure Information:

Title

Overall survival

Time Frame

3 years

Title

Objective response rate

Time Frame

3 years

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

75 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Newly diagnosed and histological proven glioblastoma Complete gross resection or subtotal resection Eastern Cooperative Oncology Group (ECOG) performance status of 0-2 Adequate bone marrow, liver and renal function Written informed consent Exclusion Criteria: Meningeal carcinomatosis or spinal compression Patients who have previously received chemotherapy, targeted therapy, or anti-angiogenesis Active, known, or suspected autoimmune disease Severe allergy to anlotinib or temozolomide Patient having acute hepatitis virus infection, active tuberculosis, or other acute infectious diseases Uncontrolled mental disorders High risk of bleeding Severe cardiovascular disease: myocardial ischemia or myocardial infarction above grade II, poorly controlled arrhythmias (including men with QTc interval ≥ 450 ms, women ≥ 470 ms), according to NYHA criteria; grades III to IV Insufficient function, or cardiac color Doppler ultrasound examination indicates left ventricular ejection fraction (LVEF) <50% Contraindicated for MRI examination Recipient of live vaccine prior to the first dose of anlotinib Ready for or previously received organ transplantation

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Heming Lu, MD

Phone

86-771-2186-504

gxheminglu@sina.com

Facility Information:

Facility Name

Nanxishan Hospital of Guangxi Zhuang Autonomous Region

City

Guilin

State/Province

Guangxi

ZIP/Postal Code

541002

Country

China

Facility Name

Liuzhou Worker's Hospital

City

Liuzhou

State/Province

Guangxi

ZIP/Postal Code

545005

Country

China

Facility Name

Liuzhou People's Hospital

City

Liuzhou

State/Province

Guangxi

ZIP/Postal Code

545006

Country

China

Facility Name

Affiliated Hospital of Guangxi Medical University

City

Nanning

State/Province

Guangxi

ZIP/Postal Code

530021

Country

China

Facility Name

Affiliated Tumor Hospital of Guangxi Medical University

City

Nanning

State/Province

Guangxi

ZIP/Postal Code

530021

Country

China

Facility Name

People's Hospital of Guangxi Zhuang Autonomous Region

City

Nanning

State/Province

Guangxi

ZIP/Postal Code

530021

Country

China

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Heming Lu, MD

Phone

+86-771-218-6503

gxheminglu@sina.com

First Name & Middle Initial & Last Name & Degree

Heming Lu, MD

Facility Name

Yulin First Hospital

City

Yulin

State/Province

Guangxi

ZIP/Postal Code

537000

Country

China

12. IPD Sharing Statement

Learn more about this trial

Addition of Anlotinib Hydrochloride to the Stupp Regimen Versus the Stupp Regimen Alone for Newly Diagnosed Glioblastoma

We'll reach out to this number within 24 hrs