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

NCT ID: NCT03567135

Last Updated: 2020-03-03

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

UNKNOWN

Total Enrollment

60 participants

Study Classification

OBSERVATIONAL

Study Start Date

2017-10-01

Study Completion Date

2020-10-01

Brief Summary

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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

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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.

Conditions

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Glioblastoma

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

RETROSPECTIVE

Study Groups

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Experimental 1

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

Apatinib

Intervention Type DRUG

These drugs are planned to inhibit the proliferation and metastasis of tumors.

Temozolomide(TMZ)

Intervention Type DRUG

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)

Temozolomide(TMZ)

Intervention Type DRUG

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)

Apatinib

Intervention Type DRUG

These drugs are planned to inhibit the proliferation and metastasis of tumors.

Temozolomide(TMZ)

Intervention Type DRUG

Radiotherapy is a common treatment for glioblastoma.Accompanied with TMZ, the damages caused by tumors to the normal tissues will be reduced.

Interventions

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Apatinib

These drugs are planned to inhibit the proliferation and metastasis of tumors.

Intervention Type 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.

Intervention Type DRUG

Other Intervention Names

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Temozolomide(TMZ)

Eligibility Criteria

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Inclusion 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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Fuzhou General Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Fuzhou General Hospital

Fuzhou, Fujian, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Wenmin Ying, Bachelor

Role: CONTACT

15080015210

Facility Contacts

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Wenmin Ying, Bachelor

Role: primary

15080015210

Other Identifiers

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20180524

Identifier Type: -

Identifier Source: org_study_id

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