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

Glioblastoma Clinical Trial

Official title:

A Retrospective Clinical Study of Postoperative Concurrent Chemoradiotherapy Combined With Anti-angiogenic Drugs in the Treatment of Glioblastoma.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03567135
• Other study ID #: 20180524
• Status: Recruiting
• Start date: October 1, 2017
• Est. completion date: October 1, 2020

Study information

• Verified date: February 2020
• Source: Fuzhou General Hospital
• Contact: Wenmin Ying, Bachelor
• Phone: 15080015210
• Email: 18352770[@]qq.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: October 1, 2020
• Est. primary completion date: April 1, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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.

Related Conditions & MeSH terms

• Glioblastoma

Intervention

Drug:
• Apatinib
These drugs are planned to inhibit the proliferation and metastasis of tumors.
• Temozolomide(TMZ)
Radiotherapy is a common treatment for glioblastoma.Accompanied with TMZ, the damages caused by tumors to the normal tissues will be reduced.

Locations

Country	Name	City	State
China	Fuzhou General Hospital	Fuzhou	Fujian

Sponsors (1)

Lead Sponsor	Collaborator
Fuzhou General Hospital

Country where clinical trial is conducted

China, 

Outcome

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