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

June 28, 2021 updated by: The Affiliated Hospital of Qingdao University

Iodine-125 Brachytherapy Together With Chemotherapy Compared With Surgical Resection Followed by Concomitant Radiochemotherapy in Patients With Newly Diagnosed Glioblastoma，a Randomized, Open-label, Multi-center Clinical Trial

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 patients with newly diagnosed glioblastoma.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

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 radiochemotherapy in patients with newly diagnosed glioblastoma.

The primary efficacy outcome was evaluated with progression-free survival (PFS).

Study Type

Interventional

Enrollment (Anticipated)

84

Phase

  • Not Applicable

Contacts and Locations

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

Study 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

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • 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 Criteria:

  • 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.
  • 5.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.

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

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Iodine-125+Chemotherapy
Iodine-125; Temozolomide
Other: Iodine-125+Chemotherapy
Iodine-125: Iodine-125 if necessary, 0.6-0.8mCi, PD:120-150Gy Temozolomide: 75 mg per square meter of body-surface area per day, 7 days per week,42 days.
Other Names:
  • Iodine-125+Temozolomide
Active Comparator: Surgical resection+Radiochemotherapy
Surgical resection; Radiotherapy; Temozolomide:
Other: Surgical resection+Radiochemotherapy

Surgical resection: Maximal surgical resection, including gross total resection, subtotal resection, and partial resection.

Radiation: total 60 Gy, 2 Gy per daily fraction (Monday to Friday) for 6 weeks. Temozolomide: 75 mg per square meter of body-surface area per day, 7 days per week,42 days.

Other Names:
  • Surgical resection+Radiotherapy+Temozolomide

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Progression-free survival (PFS)
Time Frame: 2.5 years after randomization
PFS is defined as the time from randomization to progression or death from any causes. Progression is defined as the RANO Criteria indicated.
2.5 years after randomization

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Overall Survival (OS)
Time Frame: 2.5 years after randomization
OS is defined as the time from randomization to death from any causes.
2.5 years after randomization
Survival rates at 6 months and 1 year
Time Frame: at 6 months and 1 year after operation respectively
The survival rates were measured at 6 months and 1 year
at 6 months and 1 year after operation respectively
EORTC QLQ-C30
Time Frame: 2.5 year after randomization
The Quality of life is measured with EORTC QLQ-C30 (The European Organization for Research and Treatment of Cancer Core Quality of Life questionnaire). The EORTC QLQ-C30 is designed to measure cancer patients' physical, psychological and social functions. The questionnaire is composed of multi-item scales and single items.
2.5 year after randomization
ECOG Performance Status
Time Frame: 2.5 year after randomization
ECOG PS (Eastern Cooperative Oncology Group, performance status) is to assess how a patient's disease is progressing, and how the disease affects the daily living abilities of the patient, and determine appropriate treatment and prognosis. The scale is from 0 to 5. Higher scores mean a worse outcome.
2.5 year after randomization
Complications
Time Frame: within 1 week after operation
Complications 1 week after operation were assessed. The complications after operation include headache, nausea, vomit, myodynamia, seizer, and so on.
within 1 week after operation

Collaborators and Investigators

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

Sponsor

The Affiliated Hospital of Qingdao University

Investigators

  • Principal Investigator: Xiaokun Hu, MD, The Affiliated Hospital of Qingdao University

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 (Anticipated)

June 28, 2021

Primary Completion (Anticipated)

August 1, 2022

Study Completion (Anticipated)

August 31, 2023

Study Registration Dates

First Submitted

April 20, 2021

First Submitted That Met QC Criteria

April 22, 2021

First Posted (Actual)

April 23, 2021

Study Record Updates

Last Update Posted (Actual)

June 29, 2021

Last Update Submitted That Met QC Criteria

June 28, 2021

Last Verified

June 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IC-SRC-20201119
  • 2019YFE0120100 (Other Grant/Funding Number: MOST)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

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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