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

Sponsor
Fuzhou General Hospital
Study ID
NCT03567135
Status
Unknown

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 70 Years
Healthy Volunteers
Not accepted

Interventions

  • Apatinib — DRUG
    These drugs are planned to inhibit the proliferation and metastasis of tumors.
  • Temozolomide（TMZ） — DRUG
    Radiotherapy is a common treatment for glioblastoma.Accompanied with TMZ, the damages caused by tumors to the normal tissues will be reduced.

Study Details

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.

Key Dates

Start date
Oct 1, 2017
Status verified
Feb 2020
Primary completion
Apr 1, 2019
Completion
Oct 1, 2020

Study Design

Enrollment
60 participants (estimated)

Arms

  • Arm: Experimental 1
    concurrent chemoradiotherapy（Temozolomide+apatinib） maintenance therapy（Temozolomide）
  • Arm: control
    concurrent chemoradiotherapy（Temozolomide） maintenance therapy（Temozolomide）
  • Arm: Experimental 2
    concurrent chemoradiotherapy（Temozolomide+apatinib） maintenance therapy（Temozolomide+apatinib）

Primary Outcome Measure

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. ]

Central Contacts

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