Status:

UNKNOWN

Iodine-125 Brachytherapy Together With Chemotherapy in Patients With Newly Diagnosed Glioblastoma

Lead Sponsor:

The Affiliated Hospital of Qingdao University

Conditions:

Glioblastoma

Eligibility:

All Genders

18-75 years

Phase:

NA

Brief Summary

The purpose of this study is to evaluate the efficacy and safety of Iodine-125 brachytherapy together with chemotherapy compared with surgical resection followed by concomitant radiochemotherapy in pa...

Detailed Description

This is a prospective, multicentric open-label trial to evaluate the efficacy and safety of Iodine-125 brachytherapy together with chemotherapy compared with surgical resection followed by concomitant...

Eligibility Criteria

Inclusion

  • 1\. Diagnosis of glioblastoma confirmed by histology
  • 2\. Age: 18-75 years old
  • 3\. Single lesion located in one hemisphere with a diameter between 2 and 6 centimeters
  • 4\. No prior anticancer therapy for glioblastoma besides biopsy.
  • 5\. ECOG PS:0-2 point

Exclusion

  • 1\. Infra-tentorial tumor or tumor involves the ependymal surface.
  • 2\. Nonmeasurable disease.
  • 3\. Evidence of uncontrolled intracranial pressure.
  • 4\. Severe heart, brain, and lung diseases.
  • Severe hepatic or renal dysfunction.
  • 6\. Uncontrolled, active infection.
  • 7\. Severe clotting dysfunction.
  • 8\. Pregnant.
  • 9\. Uncontrolled hypertension.
  • 10\. Participated in any other clinical treatment trial within 4 weeks before randomization.
  • 11\. Severe vascular diseases within 6 months before randomization.
  • 12\. Participants who received major surgical treatment within 4 weeks or were expected to be treated during the trial.

Key Trial Info

Start Date :

June 28 2021

Trial Type :

INTERVENTIONAL

Allocation :

ESTIMATED

End Date :

August 31 2023

Estimated Enrollment :

84 Patients enrolled

Trial Details

Trial ID

NCT04856852

Start Date

June 28 2021

End Date

August 31 2023

Last Update

June 29 2021

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Iodine-125 Brachytherapy Together With Chemotherapy in Patients With Newly Diagnosed Glioblastoma | DecenTrialz