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NCT05271240 · ClinicalTrials.gov registry record · Phase 3
Repeated Superselective Intraarterial Cerebral Infusion (SIACI) of Bevacizumab With Temozolomide and Radiation Compared to Temozolomide and Radiation Alone in Newly Diagnosed GBM
A Phase 3 study of Glioblastoma and Glioblastoma Multiforme, sponsored by Northwell Health.
- Recruiting
- Registry status
- Phase 3
- Development phase
- 432
- Enrollment target
- 1
- Study location
NCT05271240: Recruiting Phase 3 study of Glioblastoma and Glioblastoma Multiforme, sponsored by Northwell Health.
NCT05271240 is a Phase 3 study of Glioblastoma and Glioblastoma Multiforme that is actively recruiting participants, run by Northwell Health. The registered enrollment target is 432 participants, above the 107-participant average among 199 other Glioblastoma trials with a reported enrollment target (304% higher). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05271240, a Phase 3 study of Glioblastoma and Glioblastoma Multiforme, is actively recruiting participants, sponsored by Northwell Health.
- RECRUITING
- Registry status
- Phase 3
- Development phase
- 432 participants
- Enrollment target
- 1
- Study location
Study Summary
Primary brain cancer kills up to 10,000 Americans a year. These brain tumors are typically treated by surgery, radiation therapy and chemotherapy, either individually or in combination. Present therapies are inadequate, as evidenced by the low 5-year survival rate for brain cancer patients, with median survival at approximately 12 months. Glioma is the most common form of primary brain cancer, afflicting approximately 7,000 patients in the United States each year. These highly malignant cancers remain a significant unmet clinical need in oncology. The investigators have completed a Phase I clinical trial that has shown that Superselective Intraarterial Cerebral Infusion (SIACI) of Bevacizumab (BV) is safe up to a dose of 15mg/kg in patients with recurrent malignant glioma. Additionally, the investigators have shown in a recently completed Phase I/II clinical trial, that SIACI BV improves the median progression free survival (PFS) from 4-6 months to 11.5 months and overall survival (OS) from 12-15 months to 23 months in patients with newly diagnosed GBM. Therefore, this two-arm, randomized trial (2:1) is a follow up study to these trials and will ask simple questions: Will this repeated SIACI treatment regimen increase progression free survival (PFS-primary endpoint) and overall survival (OS-secondary endpoint) when compared with standard of care in patients with newly diagnosed GBM? Exploratory endpoints will include adverse events and safety analysis as well as quality of life (QOL) assessments. The investigators expect that this project will provide important information regarding the utility of repeated SIACI BV therapy for newly diagnosed GBM and may alter the way these drugs are delivered to our patients in the near future.
Primary Outcome
The primary end point will be overall survival (OS). Overall survival is defined as the time from randomization until death due to any cause. Participants who are still alive at the time of analysis will be censored at their last known alive date.
Conditions Studied
Interventions
- DRUG Repeated Superselective Intraarterial Cerebral infusion (SIACI) of Bevacizumab (Avastin) with Temozolomide and Radiation
- DRUG Temozolomide and Radiation Alone
Study Locations (1)
New York
- Lenox Hill Brain Tumor Center - New York
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 432 participants |
| Start Date | 2022-04-27 |
| Est. Completion | 2028-04-01 |
| Phase | Phase 3 |
What NCT05271240 shows while recruiting
NCT05271240 is an interventional study that assigns participants to a tested intervention. The registered 432 participants enrollment target is mid-sized for trials with a published cap, above the 107-participant average among 199 other Glioblastoma trials with a reported enrollment target (304% higher).
The record links to 7 conditions, with Glioblastoma appearing as the primary indexed condition, and to 2 interventions - of which Repeated Superselective Intraarterial Cerebral infusion (SIACI) of Bevacizumab (Avastin) with Temozolomide and Radiation is the first listed.
NCT05271240 reports a single indexed study location in New York.
Frequently Asked Questions
What is clinical trial NCT05271240 about?
NCT05271240 is a clinical study titled "Repeated Superselective Intraarterial Cerebral Infusion (SIACI) of Bevacizumab With Temozolomide and Radiation Compared to Temozolomide and Radiation Alone in Newly Diagnosed GBM". Primary brain cancer kills up to 10,000 Americans a year. These brain tumors are typically treated by surgery, radiation therapy and chemotherapy, either individually or in combination. Present therapies are inadequate, as evidenced by the low 5-year survival rate for brain cancer patients, with med...
What is the current status of trial NCT05271240?
This trial is currently recruiting. It is a Phase 3 study. The enrollment target is 432 participants. The study started on 2022-04-27. Estimated completion is 2028-04-01.
What conditions does trial NCT05271240 study?
This clinical trial studies the following conditions: Glioblastoma, Glioblastoma Multiforme, Brain Cancer, GBM, Glioma, Malignant.
What interventions are being tested in trial NCT05271240?
The interventions under investigation include: Repeated Superselective Intraarterial Cerebral infusion (SIACI) of Bevacizumab (Avastin) with Temozolomide and Radiation (DRUG), Temozolomide and Radiation Alone (DRUG).
Who is sponsoring clinical trial NCT05271240?
This trial is sponsored by Northwell Health, which has 370 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05271240 being conducted?
This trial has 1 study location across New York. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT05271240's enrollment target sits among peer trials
432 16th of 199 higher than 184 of 199 other Glioblastoma trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Glioblastoma trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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