Resection for Brain Cancer
(RECSUR Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial examines the effectiveness of surgery (tumor removal) compared to other leading cancer treatments for individuals with recurrent glioblastoma, a type of brain cancer. Researchers aim to determine if surgery extends life and improves quality of life more than treatments like chemotherapy, radiation, or experimental care. The trial suits those with recurrent glioblastoma and surgically removable tumors. Participants will either undergo surgery or receive the best cancer care recommended by doctors. As a Phase 3 trial, this study represents the final step before FDA approval, offering participants an opportunity to contribute to potentially groundbreaking treatment advancements.
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?
Research has shown that undergoing surgery again to remove a recurring glioblastoma tumor is generally safe, though some risks exist. Studies found that patients who had this second surgery lived about 11 months on average after their tumor returned, which is longer than those who did not undergo the surgery. Serious complications lasting at least three months were uncommon, occurring in about 4.9% of cases.
In the "best cancer treatment" group, options might include trying temozolomide (a chemotherapy drug) again, receiving more radiation, trying experimental treatments, or receiving supportive care. The safety of these options can vary. Temozolomide is a well-known treatment and is usually well-tolerated, but it can cause side effects like tiredness and nausea. More radiation might also cause side effects like skin changes or tiredness, but these are usually manageable.
Overall, while some risks exist, previous evidence suggests these treatments can be safe and might help patients live longer. It is important to consult with the medical team to determine the best approach for each individual.12345Why are researchers excited about this trial?
Researchers are excited about the RECSUR-study because it explores two different approaches for treating recurrent glioblastoma, a tough-to-treat brain cancer. One approach is re-resection, which involves surgically removing the recurrent tumor, offering a direct way to reduce tumor size and potentially improve symptoms. The other approach looks at the best oncological treatment, which includes options like re-challenging with temozolomide, re-irradiation, or even experimental therapies. This trial is significant because it aims to determine which of these strategies could lead to better outcomes for patients, providing valuable insights into optimizing treatment for this challenging condition.
What evidence suggests that this trial's treatments could be effective for recurrent glioblastoma?
This trial will compare two treatment approaches for recurrent glioblastoma. One arm involves re-resection, where surgery is performed again to remove the recurrent tumor. Research has shown that this approach can extend patients' lives, with studies indicating an average survival time of up to 11 months after the tumor returns, compared to 7 months for those who do not undergo surgery. In some cases, patients lived significantly longer when the entire tumor was removed compared to only part of it.
The other arm involves the best oncological treatment, which may include re-challenge with temozolomide, re-irradiation, experimental therapy, or best supportive care. For example, reusing temozolomide has kept the disease stable or partially improved in about 53% of cases. Meanwhile, additional radiation therapy has shown that 56% of patients did not experience disease progression for at least 6 months. Both treatments offer advantages, depending on the individual patient's situation.678910Who Is on the Research Team?
Jasper Gerritsen, MD PhD
Principal Investigator
Erasmus Medical Center
Are You a Good Fit for This Trial?
Inclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants undergo tumor re-resection or receive best oncological treatment, including re-challenge temozolomide, re-irradiation, experimental therapy, or best supportive care
Follow-up
Participants are monitored for safety and effectiveness after treatment, with evaluations at 6 weeks, 3 months, and 6 months postoperatively
Long-term follow-up
Participants are monitored for overall survival and progression-free survival up to 5 years postoperatively
What Are the Treatments Tested in This Trial?
Interventions
- Lomustine
- Re-irradiation
- Re-resection
- Temozolomide
How Is the Trial Designed?
2
Treatment groups
Experimental Treatment
Resection of the recurrent tumor
Best oncological treatment consisting of re-challenge temozolomide, re-irradiation, experimental therapy, or best supportive care
Find a Clinic Near You
Who Is Running the Clinical Trial?
Jasper Gerritsen
Lead Sponsor
University of California, San Francisco
Collaborator
Haaglanden Medical Centre
Collaborator
University Hospital Heidelberg
Collaborator
Universitaire Ziekenhuizen KU Leuven
Collaborator
Technical University of Munich
Collaborator
Insel Gruppe AG, University Hospital Bern
Collaborator
Massachusetts General Hospital
Collaborator
Citations
Temozolomide and Reirradiation in Recurrent Grade II Brain ...
Two patients achieved complete remission, and six achieved partial remission, with an overall objective response rate of 40%. The mean overall survival (OS) was ...
2.
acsjournals.onlinelibrary.wiley.com
acsjournals.onlinelibrary.wiley.com/doi/full/10.1002/cncr.23813Temozolomide rechallenge in recurrent malignant glioma by ...
The overall clinical benefit rate was 47% with no complete responses, 3 partial responses (14.3%), and 7 patients having stable disease (33%) ...
Second-line temozolomide in first recurrent MGMT-methylated ...
Among patients receiving temozolomide only, stable disease or partial response was achieved in 53.3%, with a progression-free survival rate at 6 ...
Re-irradiation using high precision radiotherapy and ...
Progression-free survival was 56% at 6 months after FSRT; survival after FSRT was 75% at 6 months. Median overall survival was 39 months, with ...
5.
researchgate.net
researchgate.net/publication/355608745_Temozolomide_Rechallenge_in_Patients_With_Recurrent_High-Grade_Glioma_Treated_With_Re-IrradiationTemozolomide Rechallenge in Patients With Recurrent ...
Conclusion TMZ rechallenge in patients with recurrent HGG treated with re-irradiation offered no survival benefit. Our findings suggest that patient selection ...
Prognostic evaluation of re-resection for recurrent ...
Patients undergoing re-resection had a median overall survival of 11 ± 0.7 months after recurrence compared to 7 ± 0.5 months among patients who ...
Repeat Resection for Recurrent Glioblastoma in the WHO ...
Re-resection was associated with favorable outcomes, with a median overall survival of 11 months after recurrence compared to 7 months for non-surgically ...
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.
Re-resection of brain metastases – outcomes of ... - BMC Cancer
Median intracranial progression-free survival was 7.7 months [95% CI: 6.5–11.2], time to re-resection was 11.6 months [95% CI: 9.1–15.3], and ...
Surgical Resection of Latent Brain Tumors Prior to ...
This clinical trial evaluates the side effects and possible benefits of operating on brain tumors prior to the tumor coming back (recurrence).
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