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

250 Participants Needed

What You Need to Know Before You Apply

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.

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 4 5}

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. ^{2 3 4 6 7}

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 7}

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

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 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 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 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]

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]

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 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]

Citations

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

Repeat resection in recurrent glioblastoma (3rGBM) Trial: A randomized care trial. [2022]

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]

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

Multiple microsurgical resections for repeated recurrence of glioblastoma multiforme. [2022]

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

Craniotomy for recurrent glioblastoma: Is it justified? A comparative cohort study with outcomes over 10 years. [2021]

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

Reoperation in adult patients with recurrent glioblastoma: A matched cohort analysis. [2022]

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

Residual tumor volume and patient survival following reoperation for recurrent glioblastoma. [2022]

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

The effect of re-operation on survival in patients with recurrent glioblastoma. [2015]