Repeat Surgery for Recurrent Glioblastoma

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Alberta

Disqualifiers: Informed consent not possible

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: Varies based on treatment allocation

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores whether repeat surgery for recurrent glioblastoma (GBM), an aggressive brain tumor, can improve patients' quality and length of survival. It aims to provide neurosurgeons with evidence on managing GBM without adding extra risks or tests beyond normal care. The trial includes two groups: one receiving repeat surgery and the other following standard non-surgical care. Suitable participants have had previous surgery for GBM, and their surgeon believes another surgery could enhance their survival quality. As an unphased trial, it allows patients to contribute to research that could improve future treatment strategies.

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 prior data suggests that repeat surgical management of recurrent GBM is safe?

Research has shown that undergoing another surgery for recurrent glioblastoma might extend patient survival, but it carries certain risks. One study found that patients who had a second surgery lived an average of 23.9 months, compared to 9.2 months for those who had only one surgery. However, the likelihood of post-surgery complications is higher. Specifically, another study found that about 4.9% of patients experienced complications lasting three months or more. Despite this, many patients do not face long-term issues. Considering these potential risks and benefits is crucial when evaluating the option of another surgery. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about repeat surgical management for recurrent glioblastoma because it offers a potential new approach to a very challenging condition. Unlike standard treatments that might include chemotherapy, radiation, or single surgeries, this method explores whether undergoing another surgery can better manage the tumor's regrowth. By comparing outcomes of repeat surgery against non-surgical management, researchers aim to understand if this approach could extend survival or improve quality of life for patients dealing with this aggressive brain cancer.

What evidence suggests that repeat surgical management of recurrent GBM could be effective?

Research has shown that another surgery for returning glioblastoma (GBM) can extend life expectancy. In this trial, participants in the "Repeat Surgical Resection" arm will undergo an additional surgery. One study found that patients who had a second surgery lived an average of 23.9 months, compared to 9.2 months for those who only had one surgery. Another study demonstrated that a second surgery improved survival rates, regardless of the patient's age or health condition. Additionally, patients who had more of the tumor removed during the second surgery lived longer than those with less removed. These findings suggest that another surgery might help people with returning GBM live longer and spend more time outside of hospitals. ^{1 5 6 7 8}

Are You a Good Fit for This Trial?

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.

Timeline for a Trial Participant

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

What Are the Treatments Tested in This Trial?

Interventions

• Repeat Surgical Management of Recurrent GBM

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.

How Is the Trial Designed?

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.

Who Is Running the Clinical Trial?

University of Alberta

Lead Sponsor

Trials

957

Recruited

437,000+

Published Research Related to This Trial

In a study of 42 patients with recurrent glioblastoma multiforme (GBM), those who underwent multiple surgical resections (Group A) had a median overall survival of 26 months, compared to 16 months for those who did not have further surgery (Group B).

The 2-year survival rate for patients in Group A was significantly higher at 58.3% compared to 29.0% in Group B, suggesting that repeated surgical intervention may be an effective treatment option for prolonging survival in recurrent GBM.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Multiple microsurgical resections for repeated recurrence of glioblastoma multiforme. Hong, B., Wiese, B., Bremer, M., et al.[2022]

In a study of 25 patients with recurrent glioblastoma (GBM), second surgery did not show any significant benefits in terms of survival or clinical outcomes when compared to chemotherapy alone.

Only 40% of patients who underwent reoperation received chemotherapy afterward, but the analysis indicated that the second surgery had a limited impact on the overall clinical course of the disease.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Reoperation does not provide a survival advantage in patients with recurrent Glioblastoma treated with irinotecan/bevacizumab treatment. Sever, ON., Oktay, K., Güzel, E., et al.[2022]

In a study of 97 patients with recurrent glioblastoma who underwent reoperation, the median postoperative survival was 12.4 months, highlighting the potential benefit of surgical intervention in this patient group.

Patients with larger residual tumors (>3 cm³) after reoperation had significantly decreased survival compared to those with smaller or absent residual tumors, indicating that minimizing residual tumor volume is crucial for improving overall survival.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Residual tumor volume and patient survival following reoperation for recurrent glioblastoma. Yong, RL., Wu, T., Mihatov, N., et al.[2022]

In a study of 237 patients with glioblastoma, those who underwent repeat surgical resection did not experience a significant increase in overall survival compared to those who had a single resection, with survival times being similar (17.8 months vs 17 months).

Patients who had repeat resections faced a higher rate of postoperative neurological complications, suggesting that while repeat surgery is an option, it may not provide the expected benefits and could lead to additional risks.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Reoperation in adult patients with recurrent glioblastoma: A matched cohort analysis. Yang, K., Ellenbogen, Y., Martyniuk, A., et al.[2022]

The 3rGBM trial is a multicenter, randomized study involving 250 adult patients with recurrent glioblastoma, aiming to determine if repeat surgery can improve overall survival by at least 3 months compared to standard care without repeat surgery.

This trial is designed to evaluate the effectiveness of repeat resection in a real-world clinical setting, with a focus on both survival and quality of life, measured by the number of days patients spend outside of hospital or care facilities.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Repeat resection in recurrent glioblastoma (3rGBM) Trial: A randomized care trial. Patel, M., Au, K., Easaw, JC., et al.[2022]

In a study of 232 patients with recurrent glioblastoma, re-surgery followed by chemotherapy did not show a significant impact on survival compared to chemotherapy alone.

Key prognostic factors for survival included age, MGMT methylation status, and progression-free survival at 6 months, suggesting that these factors are more critical than the choice of re-surgery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The effect of re-operation on survival in patients with recurrent glioblastoma. Franceschi, E., Bartolotti, M., Tosoni, A., et al.[2015]

In a study of 312 patients with recurrent glioblastoma multiforme, those who underwent repeat resection had a median survival since recurrence of 10.8 months compared to 6.9 months for those who did not have surgery, indicating a significant survival benefit from reoperation.

Patients who had repeat surgery also reported better quality of life scores at follow-up, with scores improving from 59 to 62, while non-operated patients' scores decreased from 54 to 51, suggesting that repeat resection not only extends survival but also enhances quality of life.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Craniotomy for recurrent glioblastoma: Is it justified? A comparative cohort study with outcomes over 10 years. Mukherjee, S., Wood, J., Liaquat, I., et al.[2021]

Citations

1.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC10177480/

Effects of Reoperation Timing on Survival among Recurrent ...

Based on our results, the best outcomes yielded GBM reoperation in the following period after the 16th month of progression, and its efficacy ...

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clinicaltrials.gov

clinicaltrials.gov/study/NCT04838782

Role of Repeat Resection in Recurrent Glioblastoma

Secondary goals include a test of the hypothesis that repeat resection can improve median overall survival, and that it can increase the number of days of ...

3.

sciencedirect.com

sciencedirect.com/science/article/abs/pii/S1878875022010191

Surgery for Recurrent Glioblastoma Multiforme

Surgery for recurrent GBM leads to improved survival independent of age, Karnofsky Performance Scale, and time to tumor recurrence.

4.

mdpi.com

mdpi.com/2076-3425/15/5/463

Repeat Resection for Recurrent Glioblastoma in the WHO ...

Results: The patients who underwent repeat resection had a significantly longer median survival of 23.9 months compared to 9.2 months in the one-surgery group ( ...

5.

annalsofoncology.org

annalsofoncology.org/article/S0923-7534(19)35115-4/fulltext

Overall survival benefit from surgical resection in treatment ...

For patients with initial STR, survival following repeat resection significantly increased with GTR compared with STR: 16.7 versus 7.4 months, P = 0.001.

6.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC12109614/

Repeat Resection for Recurrent Glioblastoma in the WHO ...

Results: The patients who underwent repeat resection had a significantly longer median survival of 23.9 months compared to 9.2 months in the one-surgery group ( ...

7.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC9389419/

Reoperation in adult patients with recurrent glioblastoma

In addition, we found that repeat surgical resection carried a higher risk of postoperative neurological complications and overall higher-grade Clavien–Dindo ...

8.

sciencedirect.com

sciencedirect.com/science/article/pii/S0967586825000852

Outcomes of awake surgery for recurrent glioblastoma

Gross total resection was achieved in 48.8 % of cases, and complications lasting at least 3 months were infrequent occurring in 4.9 % of cases.