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

Supratentorial Glioblastoma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03997136
• Other study ID #: Brain Gliomas Surgery
• Status: Not yet recruiting
• Start date: September 1, 2019
• Est. completion date: July 1, 2021

Study information

• Verified date: August 2019
• Source: Assiut University
• Contact: Amr Badary
• Phone: 00201023310102
• Email: amr.badary[@]hotmail.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 28
• Est. completion date: July 1, 2021
• Est. primary completion date: April 1, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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.

Related Conditions & MeSH terms

• Glioblastoma
• Supratentorial Glioblastoma

Intervention

Procedure:
• Supratentorial high grade gliomas resection.
Total, near total or subtotal/debulking resection of the brain supratentorial high grade gliomas

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Assiut University

References & Publications (5)

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. — View 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. — View 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. Review. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Clinical picture using Modified Rankin's Scale (mRS).	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.; - No significant disability. Able to carry out all usual activities, despite some symptoms.; - Slight disability. Able to look after own affairs without assistance, but unable to carry out all previous activities.; - Moderate disability. Requires some help, but able to walk unassisted.; - Moderately severe disability. Unable to attend to own bodily needs without assistance, and unable to walk unassisted.; - Severe disability. Requires constant nursing care and attention, bedridden, incontinent.; - Dead.	1 year
Secondary	Recurrence or increased residual	Recurrence of the tumor	within 3 months after treatment