564 Participants Needed

Tumor Resection vs Biopsy for Brain Cancer

(RESBIOP Trial)

Recruiting at 7 trial locations
JG
AV
Overseen ByArnaud Vincent, MD PhD
Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: Jasper Gerritsen
Stay on Your Current MedsYou can continue your current medications while participating
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores the best surgical approach for treating high-grade gliomas, an aggressive brain tumor, in older patients or those with limited daily functioning. It compares two methods: removing as much of the tumor as possible (resection) or taking a small tissue sample (biopsy). Participants will help researchers determine which method improves survival and quality of life and identify who can benefit most from further treatments like chemotherapy and radiotherapy. Individuals diagnosed with high-grade gliomas on an MRI, who can provide consent, might be suitable for this trial. As an unphased study, this trial offers a unique opportunity to contribute to groundbreaking research that could enhance treatment options for future patients.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Previous studies have shown that removing a tumor through surgery carries some risks, with many patients experiencing complications during or after the procedure. However, most issues improve over time and usually don't cause long-term problems.

Research indicates that a tumor biopsy is generally safe, with a low chance of serious complications or death. This suggests the procedure is usually well-tolerated, and major issues are rare.

Both treatments have their own risks, but evidence shows they are typically manageable. It's important to discuss with your doctor which option might be best for you.12345

Why are researchers excited about this trial?

Researchers are excited about this trial because it directly compares two surgical approaches—tumor resection and tumor biopsy—in treating high-grade glioma, a type of aggressive brain cancer. Resection involves removing as much of the tumor as possible, which is thought to potentially improve survival by reducing the tumor burden. In contrast, a biopsy is a less invasive procedure that takes a small tissue sample to inform treatment decisions, and it could be beneficial for patients who cannot undergo extensive surgery. The trial aims to provide insights into the effectiveness and potential benefits of each approach, helping to tailor treatment strategies for better patient outcomes.

What evidence suggests that this trial's treatments could be effective for brain cancer?

This trial will compare tumor resection with tumor biopsy for brain cancer. Studies have shown that removing more of the brain tumor often leads to better patient outcomes. Research indicates that excising a larger portion of the tumor can improve survival rates and overall health. For example, one study found that many patients had better functional abilities six months to a year after surgery. Additionally, removing the tumor can relieve pressure in the brain, potentially alleviating symptoms like difficulties in thinking or speaking. Overall, tumor removal is generally considered the standard treatment for improving outcomes in brain cancer.678910

Who Is on the Research Team?

JG

Jasper Gerritsen, MD PhD

Principal Investigator

Erasmus Medical Center

Are You a Good Fit for This Trial?

Inclusion Criteria

You have signed a form saying you agree to be in the study.
Your tumor is classified as high-grade (grade III/IV) based on MRI scans reviewed by a neurosurgeon.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Surgery

Participants undergo either tumor resection or biopsy

1 day
1 visit (in-person)

Adjuvant Treatment

Participants receive adjuvant treatment with chemotherapy and radiotherapy

6 months

Follow-up

Participants are monitored for safety, neurological morbidity, and quality of life

12 months
4 visits (in-person) at 6 weeks, 3 months, 6 months, and 12 months

What Are the Treatments Tested in This Trial?

Interventions

  • Tumor biopsy
  • Tumor resection

How Is the Trial Designed?

2

Treatment groups

Experimental Treatment

Group I: Tumor resectionExperimental Treatment1 Intervention
Group II: Tumor biopsyExperimental Treatment1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Jasper Gerritsen

Lead Sponsor

Trials
5
Recruited
3,100+

Universitaire Ziekenhuizen KU Leuven

Collaborator

Trials
1,048
Recruited
1,658,000+

Haaglanden Medical Centre

Collaborator

Trials
18
Recruited
11,200+

Insel Gruppe AG, University Hospital Bern

Collaborator

Trials
831
Recruited
2,353,000+

University Hospital Heidelberg

Collaborator

Trials
258
Recruited
278,000+

University of California, San Francisco

Collaborator

Trials
2,636
Recruited
19,080,000+

Massachusetts General Hospital

Collaborator

Trials
3,066
Recruited
13,430,000+

Technical University of Munich

Collaborator

Trials
395
Recruited
813,000+

Citations

Long-Term Outcomes of Patients with Primary Brain Tumors ...

Rehabilitation outcomes were sustained, with 125 (76.7%) and 113 (69.3%) patients having a GOS of ≥4 at 6 months and 1 year after discharge, ...

Evidence-based recommendations on categories for extent ...

Surgical resection represents the standard of care in diffuse glioma, and more extensive tumour resection appears to be associated with favourable outcome.

Surgical outcomes of brain tumors in Africa

The findings indicate suboptimal short-term outcomes, with a high in-hospital mortality rate (25.8% at 12 weeks) and a limited number of ...

Timing of glioblastoma surgery and patient outcomes

Patients with tumor volumes > 50 mL with more than a month of time-to-surgery appear to have lower extent of resection and shorter survival and could be ...

Brain Tumor Surgery

Less pressure within the skull can mean reduced symptoms and improved ability to function (for example, to think, speak or see better).

Safety and efficacy of brain biopsy: Results from a single ...

This study demonstrates that brain biopsy is a procedure with an acceptably low rate of severe complications and mortality, in line with previously published ...

Variability in biopsy quality informs translational research ...

We report biopsy safety and quality outcomes for percutaneous core biopsies of hepatocellular carcinoma (HCC) performed as part of a prospective clinical trial.

Oncological Safety of MRI-Informed Biopsy Decision ...

Findings In this cohort study involving 593 biopsy-naive men, 48% had negative MRI results, 86% of whom avoided biopsy over 3 years. After 3 ...

Navigating Biopsy Safety: Complication Rates Under ...

With a technical success rate of 97.6%, image-guided percutaneous biopsy appears to be highly effective and safe. CT-guided biopsies were ...

The percutaneous needle biopsy is safe and recommended in ...

Open incisional biopsies have a complication rate of 16%, and 8.2% of all patients who have had a biopsy have their treatment plan affected by ...