Status:
RECRUITING
THERApeutic Outcomes Related to Gut microBIOME in Glioblastoma (GBM) Patients Receiving Chemo-radiation (THERABIOME-GBM)
Lead Sponsor:
Ottawa Hospital Research Institute
Conditions:
Glioblastoma, IDH-wildtype
Eligibility:
All Genders
18+ years
Brief Summary
This is a pilot or feasibility study to test the study plan and to find out whether enough participants will join a larger study and accept the study procedures. Eligible participants (adults with new...
Detailed Description
This is a prospective observational study designed to assess changes in the gut microbial composition and diversity in prospectively collected stool samples at important time points throughout GBM tre...
Eligibility Criteria
Inclusion
- Patients with newly diagnosed WHO grade 4 glioblastoma, IDH-1 R132H wild type
- Maximum safe resection (≥70% of initial tumor volume resected)
- Age ≥ 18
- Eastern Cooperative Oncology Group (ECOG) performance status 0 to 1 or ECOG 2 if on ≤ 8 mg/day of dexamethasone (or bioequivalent)
- Plan to receive 60 Gy / 30 fractions of radiation with temozolomide within 12 weeks of surgery
- Patient or substitute decision maker able to provide written informed consent
Exclusion
- Metastatic cancer or secondary cancer that could affect interpretation of primary and secondary study outcomes
- Receiving additional systemic therapy / clinical intervention for glioblastoma that would prevent a uniform treatment cohort with temozolomide and radiation x 6 weeks followed by adjuvant temozolomide 150-200 mg/m2 on days 1-5 every 28 days for up to 6 cycles.\*
- Inability to collect study stool samples
- Any diagnosis or medical condition, physical and / or psychological, that the investigator feels precludes the patient from participation in the study.
- If there is a new standard of care treatment for newly diagnosed GBM before the first patient is enrolled (e.g., Optune Tumor Treating Fields), then we will allow all patients on this study to adopt the new standard of care therapy. To allow for maximum patient accrual, if patient chooses to enroll on an open label randomized therapeutic study whereby the control arm involves only the standard of care treatment, then patients enrolled in the control arm could be eligible for this study at the discretion of the investigator.
Key Trial Info
Start Date :
March 2 2023
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
September 1 2029
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT05326334
Start Date
March 2 2023
End Date
September 1 2029
Last Update
April 18 2023
Active Locations (1)
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1
The Ottawa Hospital Cancer Centre
Ottawa, Ontario, Canada, K1H 8L6