Clinical trial · Interventional
Iodine-125 Brachytherapy Together With Chemotherapy in Patients With Newly Diagnosed Glioblastoma
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
NCT04856852CI-TRIAL-00052461IBCNGunknownN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Glioblastoma | Glioblastoma | CURATED_BROADER | 0.80 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Iodine-125+Chemotherapy | Other | — | UNRESOLVED |
| Surgical resection+Radiochemotherapy | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Iodine-125+Chemotherapy
- description
- Iodine-125; Temozolomide
- interventionNames
- Other: Iodine-125+Chemotherapy
- type
- ACTIVE_COMPARATOR
- label
- Surgical resection+Radiochemotherapy
- description
- Surgical resection; Radiotherapy; Temozolomide:
- interventionNames
- Other: Surgical resection+Radiochemotherapy
Primary outcomes (1)
- measure
- Progression-free survival (PFS)
- timeFrame
- 2.5 years after randomization
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available
No reference posted for this study.