Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03567135
Recruitment Status : Recruiting
First Posted : June 25, 2018
Last Update Posted : March 3, 2020
Sponsor:
Information provided by (Responsible Party):
Fuzhou General Hospital

Tracking Information
First Submitted Date May 30, 2018
First Posted Date June 25, 2018
Last Update Posted Date March 3, 2020
Actual Study Start Date October 1, 2017
Actual Primary Completion Date April 1, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: June 12, 2018)
  • 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.
  • 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.
  • 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.
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Temozolomide Plus Anti-angiogenesis Drugs and Radiotherapy as a Treatment for Glioblastoma
Official Title A Retrospective Clinical Study of Postoperative Concurrent Chemoradiotherapy Combined With Anti-angiogenic Drugs in the Treatment of Glioblastoma.
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.
Study Type Observational
Study Design Observational Model: Case-Control
Time Perspective: Retrospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
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.
Condition Glioblastoma
Intervention
  • Drug: Apatinib
    These drugs are planned to inhibit the proliferation and metastasis of tumors.
    Other Name: 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.
Study Groups/Cohorts
  • Experimental 1
    concurrent chemoradiotherapy(Temozolomide+apatinib) maintenance therapy(Temozolomide)
    Interventions:
    • Drug: Apatinib
    • Drug: Temozolomide(TMZ)
  • control
    concurrent chemoradiotherapy(Temozolomide) maintenance therapy(Temozolomide)
    Intervention: Drug: Temozolomide(TMZ)
  • Experimental 2
    concurrent chemoradiotherapy(Temozolomide+apatinib) maintenance therapy(Temozolomide+apatinib)
    Interventions:
    • Drug: Apatinib
    • Drug: Temozolomide(TMZ)
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Recruiting
Estimated Enrollment
 (submitted: April 22, 2019)
60
Original Estimated Enrollment
 (submitted: June 12, 2018)
50
Estimated Study Completion Date October 1, 2020
Actual Primary Completion Date April 1, 2019   (Final data collection date for primary outcome measure)
Eligibility 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.
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years to 70 Years   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts
Contact: Wenmin Ying, Bachelor 15080015210 18352770@qq.com
Listed Location Countries China
Removed Location Countries  
 
Administrative Information
NCT Number NCT03567135
Other Study ID Numbers 20180524
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement
Plan to Share IPD: Undecided
Responsible Party Fuzhou General Hospital
Study Sponsor Fuzhou General Hospital
Collaborators Not Provided
Investigators Not Provided
PRS Account Fuzhou General Hospital
Verification Date February 2020