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

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ClinicalTrials.gov Identifier: NCT03567135
Recruitment Status : Recruiting
First Posted : June 25, 2018
Last Update Posted : April 23, 2019
Sponsor:
Information provided by (Responsible Party):
Fuzhou General Hospital

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
Glioblastoma Drug: Apatinib Drug: Temozolomide(TMZ)

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.

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Study Type : Observational
Estimated Enrollment : 60 participants
Observational Model: Case-Control
Time Perspective: Retrospective
Official Title: A Retrospective Clinical Study of Postoperative Concurrent Chemoradiotherapy Combined With Anti-angiogenic Drugs in the Treatment of Glioblastoma.
Actual Study Start Date : October 1, 2017
Actual Primary Completion Date : April 1, 2019
Estimated Study Completion Date : October 1, 2019

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
Experimental
Temozolomide concurrent radiochemotherapy Apatinib
Drug: Apatinib
These drugs are planned to inhibit the proliferation and metastasis of tumors.
Other Name: Temozolomide(TMZ)

control
Temozolomide concurrent radiochemotherapy
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.




Primary Outcome Measures :
  1. 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.

  2. 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.

  3. 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.



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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03567135


Contacts
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Contact: Wenmin Ying, Bachelor 15080015210 18352770@qq.com

Locations
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China, Fujian
Fuzhou General Hospital Recruiting
Fuzhou, Fujian, China, 350025
Contact: Wenmin Ying, Bachelor    15080015210    18352770@qq.com   
Sponsors and Collaborators
Fuzhou General Hospital

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Responsible Party: Fuzhou General Hospital
ClinicalTrials.gov Identifier: NCT03567135     History of Changes
Other Study ID Numbers: 20180524
First Posted: June 25, 2018    Key Record Dates
Last Update Posted: April 23, 2019
Last Verified: April 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Fuzhou General Hospital:
Temozolomide
Apatinib
Radiotherapy

Additional relevant MeSH terms:
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Glioblastoma
Astrocytoma
Glioma
Neoplasms, Neuroepithelial
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms, Nerve Tissue
Temozolomide
Apatinib
Antineoplastic Agents, Alkylating
Alkylating Agents
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Protein Kinase Inhibitors
Enzyme Inhibitors