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

900 Hospital of the People's Liberation Army Joint Logistic Support Force

Status: Unknown

Conditions: Glioblastoma

Treatments: Drug: Temozolomide（TMZ）; Drug: Apatinib

Study type: Observational

Funder types: Other

Identifiers

NCT03567135

20180524

Details and patient eligibility

About

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.

Full 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.

Enrollment: 60 estimated patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Search Criteria:

1. Subjects received anti-angiogenesis drugs simultaneous accompanied with radio-and chemotherapy in Fuzhou Zongyuan since October, 2017;
2. Age: 18-70 years;
3. The first surgical pathology was diagnosed as glioblastoma, WHO grade III or IV;
4. Patients who have previously received no more than one surgical treatment;
5. ECOG performance status: 0-2;
6. Survival expectation≥3 months.

Trial design

60 participants in 3 patient groups

Experimental 1

Description:

concurrent chemoradiotherapy（Temozolomide+apatinib） maintenance therapy（Temozolomide）

Treatment:

Drug: Temozolomide（TMZ）

Drug: Apatinib

control

Description:

concurrent chemoradiotherapy（Temozolomide） maintenance therapy（Temozolomide）

Treatment:

Drug: Temozolomide（TMZ）

Experimental 2

Description:

concurrent chemoradiotherapy（Temozolomide+apatinib） maintenance therapy（Temozolomide+apatinib）

Treatment:

Drug: Temozolomide（TMZ）

Drug: Apatinib