Temozolomide Plus Anti-angiogenesis Drugs and Radiotherapy as a Treatment for Glioblastoma
A Retrospective Clinical Study of Postoperative Concurrent Chemoradiotherapy Combined With Anti-angiogenic Drugs in the Treatment of Glioblastoma.
1 other identifier
observational
60
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for all trials
Started Oct 2017
Typical duration for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 1, 2017
CompletedFirst Submitted
Initial submission to the registry
May 30, 2018
CompletedFirst Posted
Study publicly available on registry
June 25, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2020
CompletedMarch 3, 2020
February 1, 2020
1.5 years
May 30, 2018
February 29, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (3)
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.
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
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
Study Arms (3)
Experimental 1
concurrent chemoradiotherapy（Temozolomide+apatinib） maintenance therapy（Temozolomide）
control
concurrent chemoradiotherapy（Temozolomide） maintenance therapy（Temozolomide）
Experimental 2
concurrent chemoradiotherapy（Temozolomide+apatinib） maintenance therapy（Temozolomide+apatinib）
Interventions
These drugs are planned to inhibit the proliferation and metastasis of tumors.
Radiotherapy is a common treatment for glioblastoma.Accompanied with TMZ, the damages caused by tumors to the normal tissues will be reduced.
Eligibility Criteria
Subjects are all previously received anti-angiogenesis drugs simultaneous accompanied with radio-and chemotherapy in Fuzhou Zongyuan since October, 2017.
Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.
Sponsors & Collaborators
Study Sites (1)
Fuzhou General Hospital
Fuzhou, Fujian, 350025, China
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- CASE CONTROL
- Time Perspective
- RETROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 30, 2018
First Posted
June 25, 2018
Study Start
October 1, 2017
Primary Completion
April 1, 2019
Study Completion
October 1, 2020
Last Updated
March 3, 2020
Record last verified: 2020-02