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A Phase III Study of Postoperative Early Temozolomide Treatment Plus STUPP Regimen for Newly Diagnosed GBM Multiforme

NCT ID: NCT05600491

Last Updated: 2022-10-31

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE3

Total Enrollment

78 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-11-08

Study Completion Date

2025-12-01

Brief Summary

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This study was to explore the effectiveness and safety of early TMZ chemotherapy between surgery and chemoradiotherapy plus the standard concomitant radiochemotherapy regimen.

Detailed Description

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This study was to explore the effectiveness and safety of early temozolomide chemotherapy between surgery and chemoradiotherapy plus the standard concomitant radiochemotherapy regimen. Patients were treated with a standard therapy regimen (Stupp) plus early postsurgical temozolomide.

Conditions

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Anaplastic Oligoastrocytoma Glioblastoma

Keywords

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Glioblastoma Multiforme chemotherapy Temozolomide

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Early TMZ chemotherapy

Patients were treated with standard concomitant radiochemotherapy regimen (Stupp) plus early postsurgical temozolomide.

Group Type EXPERIMENTAL

Temozolomide

Intervention Type DRUG

Two weeks after surgery, temozolomide was administered orally at 200 mg·m-2 ·d -1 for 5 days. From day 29, patients were treated with a standard therapy regimen (Stupp).

Interventions

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Temozolomide

Two weeks after surgery, temozolomide was administered orally at 200 mg·m-2 ·d -1 for 5 days. From day 29, patients were treated with a standard therapy regimen (Stupp).

Intervention Type DRUG

Other Intervention Names

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Temodar TMZ

Eligibility Criteria

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Inclusion Criteria

Age: 18 years to 70 years; Newly diagnosed Glioblastoma in the supratentorial cerebral hemisphere; Gross total resection or large resection of \>70% in imaging studies; Eastern Cooperative Oncology Group performance status of 0-2; Adequate bone marrow, liver and renal function; Ability of subject to understand character and individual consequences of the clinical trial Written informed consent; anticipating survival ≥7 months.

Exclusion Criteria

Refusal to participate the study; Current diagnosis or history of malignancies within the 3-year period preceding enrollment; Recurrent or multiple malignant gliomas, including gliomatosis cerebri, or metastatic extracalvarial or subtentorial lesions; Known hypersensitivity or contraindication to temozolomide; Pregnant or lactating females; Malignant tumor other than brain tumor; Contraindicated for MRI examination; Unable to comply with the follow-up studies of this trial; Uncontrolled psychotic disorders or epilepsy.
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Sun Yat-sen University

OTHER

Sponsor Role lead

Responsible Party

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Yonggao Mou

Professor and Chair, Department of Neurosurgery, Sun Yat-sen University

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Mou Y Gao, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Department of Neurosurgery/Neuro-oncology, Sun Yat-sen University Cancer Center

Locations

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Sun Yat-sen University Cancer Center

Guangzhou, Guangdong, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Mou Y Gao, MD, PhD

Role: CONTACT

Phone: +86-20-87343821

Email: [email protected]

Guo C Cheng, MD, PhD

Role: CONTACT

Phone: +86-20-87343309

Email: [email protected]

Facility Contacts

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Mou Y Gao, MD, PhD

Role: primary

Guo C Cheng, MD, PhD

Role: backup

Other Identifiers

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Yonggao Mou

Identifier Type: -

Identifier Source: org_study_id