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

Not Applicable

• Conditions: Glioblastoma

• Registration Number: NCT04856852
• Lead Sponsor: The Affiliated Hospital of Qingdao University

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 patients with newly diagnosed glioblastoma.

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 Timeline

• Study First Submitted: 2021-04-20
• Study First Submitted QC: 2021-04-22
• Study First Posted: 2021-04-23
• Status Verified: 2021-06
• Study Start: 2021-06-28
• Last Update Submitted: 2021-06-28
• Last Update Posted: 2021-06-29
• Primary Completion: 2022-08-01
• Study Completion: 2023-08-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 84

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Progression-free survival (PFS)	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.

Secondary Outcome Measures

Name	Time	Method
Overall Survival (OS)	2.5 years after randomization	OS is defined as the time from randomization to death from any causes.
Survival rates at 6 months and 1 year	at 6 months and 1 year after operation respectively	The survival rates were measured at 6 months and 1 year
EORTC QLQ-C30	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.
ECOG Performance Status	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.
Complications	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.