Temozolomide Plus Anti-angiogenesis Drugs and Radiotherapy as a Treatment for Glioblastoma

• Conditions: Glioblastoma
• Interventions: Drug: Apatinib; Drug: Temozolomide（TMZ）

• Registration Number: NCT03567135
• Lead Sponsor: Fuzhou General Hospital

Brief Summary

Temozolomide (TMZ) is an oral chemotherapy drug. It is an alkylating agent used as a first-line treatment for glioblastoma. This methylation damages the DNA and triggers the death of tumor cells. According to the results of several clinical studies, TMZ synchronous plus radiotherapy and subsequent as adjuvant therapy can significantly improve the survival rate of newly diagnosed glioblastoma patients.

Detailed Description

Glioma is the highest incidence of the central nervous system tumor. Surgical treatment is one of the most important therapeutic methods in patients with glioblastoma. But since malignant glioma is a highly invasive tumor, the rate of surgery failure is . So the postoperative therapy shall be accompanied by radiotherapy. Since 1998, the clinical application of Temozolomide(TMZ) has brought hope for malignant glioma patients with its definite curative effect. According to the results of several clinical studies, TMZ synchronous plus radiotherapy and subsequent as adjuvant therapy can significantly improve the survival rate of newly diagnosed GBM patients and break the survival limit of malignant glioma patients. Besides, antiangiogenic therapy is also a choice for the treatment of glioblastoma patients. Vascular endothelial growth factor receptors (VEGFRs) inhibitors block the new formation around the tumor and cut down the supply of oxygen, nutrients and metabolic waste, so that the tumor is hard to proliferate and metastases.

Study Timeline

• Study Start: 2017-10-01
• Study First Submitted: 2018-05-30
• Study First Submitted QC: 2018-06-12
• Study First Posted: 2018-06-25
• Primary Completion: 2019-04-01
• Status Verified: 2020-02
• Last Update Submitted: 2020-02-29
• Last Update Posted: 2020-03-03
• Study Completion: 2020-10-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Experimental 1	Temozolomide（TMZ）	concurrent chemoradiotherapy（Temozolomide+apatinib） maintenance therapy（Temozolomide）
Experimental 2	Temozolomide（TMZ）	concurrent chemoradiotherapy（Temozolomide+apatinib） maintenance therapy（Temozolomide+apatinib）
control	Temozolomide（TMZ）	concurrent chemoradiotherapy（Temozolomide） maintenance therapy（Temozolomide）
Experimental 1	Apatinib	concurrent chemoradiotherapy（Temozolomide+apatinib） maintenance therapy（Temozolomide）
Experimental 2	Apatinib	concurrent chemoradiotherapy（Temozolomide+apatinib） maintenance therapy（Temozolomide+apatinib）

Primary Outcome Measures

Name	Time	Method
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 36 months.	in this Survival Duration neither Progression nor death occurs in the subjects.
Assessment of brain edema	From date of randomization until the date of end of the trial, assessed up to 36 months	The average score of edema grading in patients before and after treatment was calculated separately.
Number of participants with treatment-related adverse events as assessed by CTCAE v4.0	From date of randomization until the date of end of the trial, assessed up to 36 months	To observe any adverse events that occurred during the clinical study.

Trial Locations

Locations (1)

Fuzhou General Hospital; 🇨🇳 Fuzhou, Fujian, China