Temozolomide Plus Anti-angiogenesis Drugs and Radiotherapy as a Treatment for Glioblastoma
Study Details
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 | Phase |
|---|---|---|
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
Arms and Interventions
| Arm | 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 Names:
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 Names:
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) [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.
Eligibility Criteria
Criteria
Search Criteria:
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Subjects received anti-angiogenesis drugs simultaneous accompanied with radio-and chemotherapy in Fuzhou Zongyuan since October, 2017;
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Age: 18-70 years;
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The first surgical pathology was diagnosed as glioblastoma, WHO grade III or IV;
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Patients who have previously received no more than one surgical treatment;
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ECOG performance status: 0-2;
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Survival expectation≥3 months.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Fuzhou General Hospital | Fuzhou | Fujian | China | 350025 |
Sponsors and Collaborators
- Fuzhou General Hospital
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 20180524