Glioblastoma
Conditions
Keywords
Temozolomide, Apatinib, Radiotherapy
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.
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.
Interventions
DRUGApatinib
These drugs are planned to inhibit the proliferation and metastasis of tumors.
DRUGTemozolomide（TMZ）
Radiotherapy is a common treatment for glioblastoma.Accompanied with TMZ, the damages caused by tumors to the normal tissues will be reduced.
Sponsors
Fuzhou General Hospital
Study design
Observational model
CASE_CONTROL
Time perspective
RETROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
China
Contacts
Primary ContactWenmin Ying, Bachelor
Outcome results
None listed