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

Qingdao University

Status: Unknown

Conditions: Glioblastoma

Treatments: Other: Surgical resection+Radiochemotherapy; Other: Iodine-125+Chemotherapy

Study type: Interventional

Funder types: Other

Identifiers

NCT04856852

IC-SRC-20201119

2019YFE0120100 (Other Grant/Funding Number)

Details and patient eligibility

About

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.

Full 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).

Enrollment: 84 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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84 participants in 2 patient groups

Iodine-125+Chemotherapy

Experimental group

Description:

Iodine-125; Temozolomide

Treatment:

Other: Iodine-125+Chemotherapy

Surgical resection+Radiochemotherapy

Active Comparator group

Description:

Surgical resection; Radiotherapy; Temozolomide:

Treatment:

Other: Surgical resection+Radiochemotherapy