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

Glioblastoma Clinical Trial

— IBCNG  

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04856852
• Other study ID #: IC-SRC-20201119
• Secondary ID: 2019YFE0120100
• Status: Not yet recruiting
• Phase: N/A
• Start date: June 28, 2021
• Est. completion date: August 31, 2023

Study information

• Verified date: June 2021
• Source: The Affiliated Hospital of Qingdao University
• Contact: Xiaokun Hu, PhD
• Phone: +8618661801166
• Email: huxiaokun770[@]163.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 84
• Est. completion date: August 31, 2023
• Est. primary completion date: August 1, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Glioblastoma

Intervention

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.
• 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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
The Affiliated Hospital of Qingdao University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Progression-free survival (PFS)	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	Overall Survival (OS)	OS is defined as the time from randomization to death from any causes.	2.5 years after randomization
Secondary	Survival rates at 6 months and 1 year	The survival rates were measured at 6 months and 1 year	at 6 months and 1 year after operation respectively
Secondary	EORTC QLQ-C30	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
Secondary	ECOG Performance Status	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
Secondary	Complications	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