Prognostic Impact of Surgical Resection Extent for Supratentorial High Grade Gliomas.

• Conditions: Supratentorial Glioblastoma

• Registration Number: NCT03997136
• Lead Sponsor: Assiut University

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.

Study Timeline

• Study First Submitted: 2019-06-21
• Study First Submitted QC: 2019-06-24
• Study First Posted: 2019-06-25
• Status Verified: 2019-08
• Last Update Submitted: 2019-08-06
• Last Update Posted: 2019-08-07
• Study Start: 2019-09-01
• Primary Completion: 2021-04-01
• Study Completion: 2021-07-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 28

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Clinical picture using Modified Rankin's Scale (mRS).	1 year	The changes in clinical condition of the patients will be assessed using Modified Rankin's Scale (mRS) before and after treatment.; The scale runs from 0-6, running from perfect health without symptoms to death. 0 - No symptoms.; 1. - No significant disability. Able to carry out all usual activities, despite some symptoms.; 2. - Slight disability. Able to look after own affairs without assistance, but unable to carry out all previous activities.; 3. - Moderate disability. Requires some help, but able to walk unassisted.; 4. - Moderately severe disability. Unable to attend to own bodily needs without assistance, and unable to walk unassisted.; 5. - Severe disability. Requires constant nursing care and attention, bedridden, incontinent.; 6. - Dead.

Secondary Outcome Measures

Name	Time	Method
Recurrence or increased residual	within 3 months after treatment	Recurrence of the tumor