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

February 29, 2020 updated by: Fuzhou General Hospital

A Retrospective Clinical Study of Postoperative Concurrent Chemoradiotherapy Combined With Anti-angiogenic Drugs in the Treatment of Glioblastoma.

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Anticipated)

60

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Fujian
      • Fuzhou, Fujian, China, 350025
        • Recruiting
        • Fuzhou General Hospital
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years to 68 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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.

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Control
  • Time Perspectives: Retrospective

Cohorts and Interventions

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 Names:
  • 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 Names:
  • 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
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
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.
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
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.
From date of randomization until the date of end of the trial, assessed up to 36 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Fuzhou General Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 1, 2017

Primary Completion (Actual)

April 1, 2019

Study Completion (Anticipated)

October 1, 2020

Study Registration Dates

First Submitted

May 30, 2018

First Submitted That Met QC Criteria

June 12, 2018

First Posted (Actual)

June 25, 2018

Study Record Updates

Last Update Posted (Actual)

March 3, 2020

Last Update Submitted That Met QC Criteria

February 29, 2020

Last Verified

February 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 20180524

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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