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Surgical Resection of Latent Brain Tumors Prior to Recurrence

ConditionBrain Neoplasm
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorMayo Clinic

About this trial

This clinical trial evaluates the side effects and possible benefits of operating on brain tumors prior to the tumor coming back (recurrence). Understanding when surgery is most useful to patients with brain tumors is important. Some patients may undergo chemotherapy or radiation but still have visible tumor remaining after treatment. The purpose of this research is to compare outcomes of those who have surgery after chemotherapy or radiation, but prior to tumor recurrence, to those who have surgery at a different time, or no surgery at all.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Age >= 18 years

Histological or cytological confirmation of brain tumor and/or suspected brain tumor based on clinical and radiologic findings

Prior chemotherapy and/or radiation treatment directed to the known/suspected tumor

Radiographic evidence of residual or previously unresected tumor

Disqualifiers

Age < 18 years

Found to be a member of a vulnerable population (e.g. pregnant, lacking capacity to consent) during the course of pre-enrollment or pre-surgical assessment

Prior gross total resection of brain tumor leading to absence of visible latent disease (exemption available for post-operative enrollment)

Any contraindication to surgery, including anyone who in the opinion of the surgeon is at unreasonably elevated risk of wound complications

Trial design

Design model

Single group

Treatments tested in this trial

  • Brain Surgery

    Procedure/Surgery

    Undergo surgery

Treatment groups

40 Participants
are divided into 1 treatment group
Group A: Treatment (surgery)Experimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Feasibility of surgical resection by short and long term outcomes

Feasibility will be evaluated by meeting enrollment criteria.

Time frame
Up to 5 years
2

Incidence of adverse events

Safety will be evaluated by recording adverse events utilizing proper reporting measures.

Time frame
Up to 5 years

Secondary outcomes

1

Overall survival

Median time of survival along with 95% confidence interval will be estimated using the Kaplan-Meier method.

Time frame
Time from initial diagnosis to the date of death/or censored at the time of last known alive, assessed up to 5 years
2

Progression free survival

Median time of progress-free survival along with the 95% confidence interval will be estimated using the Kaplan Meier method.

Time frame
Time from initial diagnosis to the date progression is identified, assessed up to 5 years
3

Neurosurgical morbidity

Postoperative complications such as wound infection and neurologic deficits will be logged. Additional metrics including hospital stay and readmission rates will also be logged. Standard descriptive statistics will be used to summarize the outcomes.

Time frame
Up to completion of surgery
4

Time to subsequent treatment (i.e. chemotherapy/immunotherapy and/or radiation)

Median time to subsequent treatment along with the 95% confidence interval will be estimated using standard descriptive statistics.

Time frame
Time from surgical resection at Mayo Clinic until an adjuvant treatment is administered, assessed up to 5 years

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Mayo Clinic

Lead sponsor

Source ClinicalTrials.gov
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