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Repeat Surgery for Recurrent Glioblastoma

N/A

Recruiting

Research Sponsored by University of Alberta

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Previously histologically confirmed and surgically resected Glioblastoma

Previous craniotomy for open tumor resection (needle biopsies alone do not count as resection)

Timeline

Screening 3 weeks

Treatment Varies

Follow Up follow-up for 5 years or until death

Awards & highlights

Study Summary

This trial is important because it will help neurosurgeons manage patients with recurrent GBM in the best way possible.

Who is the study for?

This trial is for adults over 18 with recurrent Glioblastoma (GBM) who've had it surgically removed before. Candidates should be considered by their surgeon to potentially benefit in quality of life from another surgery. Those unable to give informed consent are excluded.Check my eligibility

What is being tested?

The study tests the effectiveness of repeat surgical resection on patients with recurrent GBM, aiming to see if a second surgery can extend overall survival and improve time spent out of hospitals or care facilities without extra risks beyond standard care.See study design

What are the potential side effects?

Since the intervention involves routine surgical procedures, potential side effects include typical surgical risks such as infection, bleeding, neurological deficits depending on tumor location, and general anesthesia complications.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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My glioblastoma was confirmed by a biopsy and has been surgically removed.

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I have had brain surgery to remove a tumor.

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I am 18 years old or older.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ follow-up for 5 years or until death

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~follow-up for 5 years or until death

This trial's timeline: 3 weeks for screening, Varies for treatment, and follow-up for 5 years or until death for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Length of Overall Survival

Secondary outcome measures

Discharge to a location other than home

Aphasia

Incidence of peri-operative non-neurological complications (wound infection, CSF leaks)

+2 more

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Repeat Surgical ResectionExperimental Treatment1 Intervention

Standard surgical operative management according to local practices.

Group II: Management Without Re-operationActive Control1 Intervention

Non-surgical management with standard care according to local practices.

0 / 3Eligibility criteria met

Find a Location

Who is running the clinical trial?

University of AlbertaLead Sponsor

888 Previous Clinical Trials

384,708 Total Patients Enrolled

1 Trials studying Glioblastoma

40 Patients Enrolled for Glioblastoma

Media Library

Repeat Surgical Management of Recurrent GBM Clinical Trial Eligibility Overview. Trial Name: NCT04838782 — N/A

Glioblastoma Research Study Groups: Repeat Surgical Resection, Management Without Re-operation

Glioblastoma Clinical Trial 2023: Repeat Surgical Management of Recurrent GBM Highlights & Side Effects. Trial Name: NCT04838782 — N/A

Repeat Surgical Management of Recurrent GBM 2023 Treatment Timeline for Medical Study. Trial Name: NCT04838782 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

How many participants have enrolled in this research project thus far?

"Affirmative. The clinical trial is still recruiting according to the information published on clinicaltrials.gov, which was first posted in late August 2021 and last revised on April 5th 2022. Approximately 250 volunteers are sought for this single-site research project."

Answered by AI

Is recruitment still underway for this research initiative?

"Clinicaltrials.gov confirms that the recruitment process for this medical study is ongoing, having been first posted on August 26th 2021 and last updated on April 5th 2022."

Answered by AI

Recent research and studies

World NeurosurgeryJournal

Recruitment in Clinical Trials: The Use of Zelen's Prerandomization in Recent Neurovascular Studies

Raymond, Jean, Tim E. Darsaut, and David J. Roy. 2017. “Recruitment in Clinical Trials: The Use of Zelen's Prerandomization in Recent Neurovascular Studies”. World Neurosurgery. Elsevier BV. doi:10.1016/j.wneu.2016.11.052.

Cancer Epidemiology, Biomarkers & PreventionJournal

Epidemiologic and Molecular Prognostic Review of Glioblastoma

Thakkar, Jigisha P., Therese A. Dolecek, Craig Horbinski, Quinn T. Ostrom, Donita D. Lightner, Jill S. Barnholtz-Sloan, and John L. Villano. 2014. “Epidemiologic and Molecular Prognostic Review of Glioblastoma”. Cancer Epidemiology, Biomarkers & Prevention. American Association for Cancer Research (AACR). doi:10.1158/1055-9965.epi-14-0275.

Clinical Neurology and NeurosurgeryJournal

The Influence of Surgery on Recurrence Pattern of Glioblastoma

De Bonis, Pasquale, Carmelo Anile, Angelo Pompucci, Alba Fiorentino, Mario Balducci, Silvia Chiesa, Libero Lauriola, Giulio Maira, and Annunziato Mangiola. 2013. “The Influence of Surgery on Recurrence Pattern of Glioblastoma”. Clinical Neurology and Neurosurgery. Elsevier BV. doi:10.1016/j.clineuro.2012.04.005.

Journal of NeurosurgeryJournal