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

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ClinicalTrials.gov Identifier: NCT03567135

Recruitment Status : Recruiting

First Posted : June 25, 2018

Last Update Posted : March 3, 2020

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Sponsor:

Information provided by (Responsible Party):

Fuzhou General Hospital

Study Description

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.

Condition or disease	Intervention/treatment
Glioblastoma	Drug: Apatinib Drug: Temozolomide（TMZ）

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 Design

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Study Type :	Observational
Estimated Enrollment :	60 participants
Observational Model:	Case-Control
Time Perspective:	Retrospective
Official Title:	A Retrospective Clinical Study of Postoperative Concurrent Chemoradiotherapy Combined With Anti-angiogenic Drugs in the Treatment of Glioblastoma.
Actual Study Start Date :	October 1, 2017
Actual Primary Completion Date :	April 1, 2019
Estimated Study Completion Date :	October 1, 2020

Resource links provided by the National Library of Medicine

Drug Information available for: Temozolomide

Genetic and Rare Diseases Information Center resources: Glioblastoma Glioma Neuroepithelioma

U.S. FDA Resources

Groups and Cohorts

Group/Cohort	Intervention/treatment
Experimental 1 concurrent chemoradiotherapy（Temozolomide+apatinib） maintenance therapy（Temozolomide）	Drug: Apatinib These drugs are planned to inhibit the proliferation and metastasis of tumors. Other Name: Temozolomide（TMZ） Drug: Temozolomide（TMZ） Radiotherapy is a common treatment for glioblastoma.Accompanied with TMZ, the damages caused by tumors to the normal tissues will be reduced.
control concurrent chemoradiotherapy（Temozolomide） maintenance therapy（Temozolomide）	Drug: Temozolomide（TMZ） Radiotherapy is a common treatment for glioblastoma.Accompanied with TMZ, the damages caused by tumors to the normal tissues will be reduced.
Experimental 2 concurrent chemoradiotherapy（Temozolomide+apatinib） maintenance therapy（Temozolomide+apatinib）	Drug: Apatinib These drugs are planned to inhibit the proliferation and metastasis of tumors. Other Name: Temozolomide（TMZ） Drug: Temozolomide（TMZ） Radiotherapy is a common treatment for glioblastoma.Accompanied with TMZ, the damages caused by tumors to the normal tissues will be reduced.

Outcome Measures

Primary Outcome Measures :

Progression-Free-Survival(PFS) [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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.

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:	18 Years to 70 Years (Adult, Older Adult)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No
Sampling Method:	Probability Sample

Study Population

Subjects are all previously received anti-angiogenesis drugs simultaneous accompanied with radio-and chemotherapy in Fuzhou Zongyuan since October, 2017.

Criteria

Search Criteria:

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

Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03567135

Contacts

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Contact: Wenmin Ying, Bachelor	15080015210	18352770@qq.com

Locations

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China, Fujian
Fuzhou General Hospital	Recruiting
Fuzhou, Fujian, China, 350025
Contact: Wenmin Ying, Bachelor 15080015210 18352770@qq.com

Sponsors and Collaborators

Fuzhou General Hospital

More Information

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Responsible Party:	Fuzhou General Hospital
ClinicalTrials.gov Identifier:	NCT03567135
Other Study ID Numbers:	20180524
First Posted:	June 25, 2018 Key Record Dates
Last Update Posted:	March 3, 2020
Last Verified:	February 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD:	Undecided

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Studies a U.S. FDA-regulated Drug Product:	No
Studies a U.S. FDA-regulated Device Product:	No

Keywords provided by Fuzhou General Hospital:


Temozolomide Apatinib Radiotherapy

Additional relevant MeSH terms:

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Glioblastoma Astrocytoma Glioma Neoplasms, Neuroepithelial Neuroectodermal Tumors Neoplasms, Germ Cell and Embryonal Neoplasms by Histologic Type Neoplasms Neoplasms, Glandular and Epithelial	Neoplasms, Nerve Tissue Temozolomide Apatinib Antineoplastic Agents, Alkylating Alkylating Agents Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Protein Kinase Inhibitors Enzyme Inhibitors

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