Clinical trial NCT03997136: Prognostic Impact of Surgical Resection Extent for Supratentorial High Grade Gliomas.
Official title: Prognostic Impact of Surgical Resection Extent for Supratentorial High Grade Gliomas.
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Supratentorial Glioblastoma
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2019-06-25
Enrollment: 28
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All cases of patients of supratentorial high grade gliomas that fullfill the selection criteria that will be admitted in the department of neurosurgery in Assuit university hospital. (Non propability sample size) with expected size of 28 patients starting from 01/07/2019 to 15/06/2021.

Patients whose follow-ups will be lost due to any other cause will be excluded from this study (expected to be 25%). Additionally, the competence of follow-up will be approved by imaging and medical records.

Brief summary: Prospective randomized controlled clinical trials (single arm study) of surgical treatment modalities for supratentorial high grade gliomas within the next two years.

Detailed description: Supratentorial high grade gliomas are for surgical resection in any case according to many factors.

Investigators will compare the outcomes/survival rate and clinical outcome of the different resection types (Total, near total, subtotal/debulking) of supratentorial high grade gliomas according to the clinical condition and comorbidities of the patient, the location and morphology of the lesion, the grading of lesions, and the clinical experience of the neurosurgeon.

Eligibility criteria: Inclusion Criteria:

* Patients who will undergo surgical excision of the supratentorial high grade gliomas at the time of study (two years).
* Denovo disease for the first time.
* Any age

Exclusion Criteria:

* Low-grade Gliomas.
* Infratentorial high-grade gliomas.
* Past history of gliomas.
* Patients who are unfit for any neurosurgical interventions.
* Patients who do not receive their adjuvant standard therapy.

Primary outcomes:
measure: Clinical picture using Modified Rankin's Scale (mRS).
timeFrame: 1 year
Secondary outcomes:
measure: Recurrence or increased residual
timeFrame: within 3 months after treatment
Other outcomes:
Locations:
Study officials:
affiliation: Assiut University
name: Mahmoud Ragab
role: STUDY_DIRECTOR
References:
citation: Gulati S, Jakola AS, Nerland US, Weber C, Solheim O. The risk of getting worse: surgically acquired deficits, perioperative complications, and functional outcomes after primary resection of glioblastoma. World Neurosurg. 2011 Dec;76(6):572-9. doi: 10.1016/j.wneu.2011.06.014.
citation: Ostrom QT, Bauchet L, Davis FG, Deltour I, Fisher JL, Langer CE, Pekmezci M, Schwartzbaum JA, Turner MC, Walsh KM, Wrensch MR, Barnholtz-Sloan JS. The epidemiology of glioma in adults: a "state of the science" review. Neuro Oncol. 2014 Jul;16(7):896-913. doi: 10.1093/neuonc/nou087.
citation: Ryken TC, Frankel B, Julien T, Olson JJ. Surgical management of newly diagnosed glioblastoma in adults: role of cytoreductive surgery. J Neurooncol. 2008 Sep;89(3):271-86. doi: 10.1007/s11060-008-9614-5. Epub 2008 Aug 20. No abstract available.
citation: Sanai N, Polley MY, McDermott MW, Parsa AT, Berger MS. An extent of resection threshold for newly diagnosed glioblastomas. J Neurosurg. 2011 Jul;115(1):3-8. doi: 10.3171/2011.2.jns10998. Epub 2011 Mar 18.
citation: Orringer D, Lau D, Khatri S, Zamora-Berridi GJ, Zhang K, Wu C, Chaudhary N, Sagher O. Extent of resection in patients with glioblastoma: limiting factors, perception of resectability, and effect on survival. J Neurosurg. 2012 Nov;117(5):851-9. doi: 10.3171/2012.8.JNS12234. Epub 2012 Sep 14.