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Glioma Supra Marginal Incision Trial

High Grade Glioma

G-SUMIT is a pilot, phase II,randomized controlled trial to evaluate the feasibility of performing a large-scale trial in patients undergoing surgery for first-time diagnosis of high grade glioma (HGG) in a surgically favorable anatomical location to answer the following:

Does extending the margin of resection 1 cm beyond visible enhanced volume on MRI result in (a) an increase in overall survival? (b) result in a similar rate of "clinically-significant" neurological worsening during 30 days post surgery and quality of life at 6 and 12 months?

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Conditions de participation

  • Sexe:

    ALL

  • Âges admissibles:

    18 to 85

Critères de participation

Inclusion Criteria:

1. Radiographic evidence of a GAD-enhancing intra-axial tumor consistent with HGG;
2. Age ≥18 ≤ 85 years;
3. Karnofsky Performance Score ≥ 60;
4. Location of tumor in a safe anatomical location and
5. Patient or substitute decision maker (SDM) able to understand and consent to study participation.

Exclusion Criteria:

1. Multi-focal tumor, gliomatosis cerebri (≥3 lobes of the brain affected), tumors crossing the midline, or leptomeningeal enhancement;
2. Previous craniotomy for tumor excision (stereotactic biopsy is permitted);
3. Known metastatic cancer;
4. Uncorrectable coagulopathy;
5. Unable to obtain GAD-enhanced brain MRI.

Lieu de l'étude

Sunnybrook Health Sciences Centre
Sunnybrook Health Sciences Centre
Toronto, Ontario
Canada

Contactez l'équipe d'étude

Primary Contact

Farhad Pirouzmand, MD, MSc, FRCSC

[email protected]
416-480-6100
St Michael's Hospital
St Michael's Hospital
Toronto, Ontario
Canada

Contactez l'équipe d'étude

Primary Contact

Clementine k Affana

[email protected]
Mackenzie Health Sciences Center
Mackenzie Health Sciences Center
Edmonton, Alberta
Canada

Contactez l'équipe d'étude

Primary Contact

Mathew Mossey

[email protected]
University of Saskatchewan
University of Saskatchewan
Saskatoon, Saskatchewan
Canada

Contactez l'équipe d'étude

Primary Contact

Jessica Grosskleg

[email protected]
Kingston Health Sciences Centre
Kingston Health Sciences Centre
Kingston, Ontario
Canada

Contactez l'équipe d'étude

Primary Contact

Craig Spencer

[email protected]
Étude parrainée par
Sunnybrook Health Sciences Centre
Participants recherchés
Plus d'informations
ID de l'étude: NCT04737577