Repeat Surgery for Recurrent Glioblastoma

Recruiting in Palo Alto (17 mi)

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Recruiting

Sponsor: University of Alberta

Disqualifiers: Informed consent not possible

No Placebo Group

Trial Summary

What is the purpose of this trial?

This trial is testing if performing another surgery to remove a brain tumor can help patients with Glioblastoma live longer and spend more time at home instead of in medical facilities.

Will I have to stop taking my current medications?

The trial protocol does not specify whether you need to stop taking your current medications.

What data supports the effectiveness of the treatment Repeat Surgical Management of Recurrent GBM?

The research indicates that while repeat surgery for recurrent glioblastoma can help confirm the diagnosis and relieve symptoms, there is no clear evidence that it improves survival or quality of life. The effectiveness of this treatment remains uncertain and controversial. ^{1 2 3 4 5}

Is repeat surgery for recurrent glioblastoma safe?

The studies reviewed do not provide specific safety data for repeat surgery in recurrent glioblastoma, but they do mention that reoperation is used to confirm diagnosis and relieve symptoms, suggesting it is generally considered safe enough to be performed in practice. ^{1 2 3 5 6}

How is repeat surgery for recurrent glioblastoma different from other treatments?

Repeat surgery for recurrent glioblastoma is unique because it involves performing another surgical operation to remove the tumor after it has returned, which can help confirm the diagnosis and relieve symptoms, but its impact on extending life is still uncertain. ^{1 2 3 4 7}

Eligibility Criteria

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.

Inclusion Criteria

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

I have had brain surgery to remove a tumor.

The surgeon believes that another operation could help you live longer or have a better quality of life.

Exclusion Criteria

You are unable to provide consent for the study.

Trial Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants are randomized to either repeat surgical resection or non-surgical management

Varies based on treatment allocation

Follow-up

Participants are monitored for overall survival and quality survival, with follow-up visits to assess outcomes

5 years or until death

Treatment Details

Interventions

• Repeat Surgical Management of Recurrent GBM (Surgery)

Trial Overview 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.

Participant Groups

Group I: Repeat Surgical Resection Experimental Treatment 1 Intervention

Standard surgical operative management according to local practices.

Group II: Management Without Re-operation Active Control 1 Intervention

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

Find a Clinic Near You

Research Locations Nearby Select from list below to view details:

University of Alberta Division of Neurosurgery Edmonton, Canada

Who Is Running the Clinical Trial?

University of Alberta Lead Sponsor

References

1. France pubmed.ncbi.nlm.nih.gov

Repeat resection in recurrent glioblastoma (3rGBM) Trial: A randomized care trial. [2022] The prognosis for patients with recurrent glioblastoma (GBM) is dismal, and the question of repeat surgery at time of recurrence is common. Re-operation in the management of these patients remains controversial, as there is no randomized evidence of benefit. An all-inclusive pragmatic care trial is needed to evaluate the role of repeat resection.

2. India pubmed.ncbi.nlm.nih.gov

Reoperation does not provide a survival advantage in patients with recurrent Glioblastoma treated with irinotecan/bevacizumab treatment. [2022] Treatment options for recurrent glioblastoma (GBM) have limited efficacy. Although reoperation is useful for both the confirmation of the diagnosis of recurring disease and the relief of the symptoms, its effect on survival is unknown. The aim of this study was to evaulate the impact of second surgery in recurrent GBM.

3. United States pubmed.ncbi.nlm.nih.gov

Multiple microsurgical resections for repeated recurrence of glioblastoma multiforme. [2022] There has been little evidence so far supporting further surgical intervention in case of repeated recurrence of glioblastoma multiforme (GBM). Thus, the efficacy and utility of repeated resection remains unclear but worthy of consideration. The aim of this study was to review the efficacy of multiple repeated resections in patients with recurrent GBM.

4. Netherlands pubmed.ncbi.nlm.nih.gov

Craniotomy for recurrent glioblastoma: Is it justified? A comparative cohort study with outcomes over 10 years. [2021] The role of repeat resection for recurrent glioblastoma multiforme (rGBM) is unclear. This large comparative cohort study assessed overall survival (OS), survival since recurrence (SSR), quality of life, and complications in reoperated versus non-reoperated patients for rGBM.

5. England pubmed.ncbi.nlm.nih.gov

Reoperation in adult patients with recurrent glioblastoma: A matched cohort analysis. [2022] Despite maximal safe cytoreductive surgery and postoperative adjuvant therapies, glioblastoma (GBM) inevitably recurs and leads to deterioration of neurological status and eventual death. There is no consensus regarding the benefit of repeat resection for enhancing survival or quality of life in patients with recurrent GBM. We aimed to examine if reoperation for GBM recurrence incurs a survival benefit as well as examine its complication profile.

6. United States pubmed.ncbi.nlm.nih.gov

Residual tumor volume and patient survival following reoperation for recurrent glioblastoma. [2022] Maximal safe tumor resection is part of the standard of care for patients with newly diagnosed glioblastoma. The role of reoperation in the care of patients with recurrent glioblastoma is less clear, and less than a quarter of patients undergo a second surgery. Previous studies have identified preoperative variables associated with the improved survival of patients following reoperation, and guidelines for the selection of patients for reoperation have been devised and validated. In this study, the authors analyzed the relative survival benefit of maximal safe tumor removal in a series of patients with recurrent glioblastoma who all underwent reoperation.

7. Greece pubmed.ncbi.nlm.nih.gov

The effect of re-operation on survival in patients with recurrent glioblastoma. [2015] Treatment options for glioblastoma (GBM) at recurrence have limited efficacy. Re-surgery has been used for confirmation of recurrent disease and to provide relief of symptoms but the real impact on survival is unknown.