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Supratotal Resection for Gliomas Within Noneloquent Areas

Primary Purpose

Glioma

Status
Unknown status
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
total resection
supratotal resection
Sponsored by
Southwest Hospital, China
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Glioma focused on measuring surgery, noneloquent area

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. Individuals aged 18-80 years with highly suspected (as assessed by study surgeon), newly diagnosed, untreated glioma
  2. Tumor in noneloquent brain areas diagnosed by Head MRI, an eloquent areas is defined according to the recent UCSF (University of California, San Francisco) classification, including the sensor motor areas (precentral and postcentral gyri), perisylvian language areas in the dominant hemisphere (superior temporal, inferior frontal, and inferior parietal gyri), basal ganglia, internal capsule, thalamus, and visual cortex around the calcarine sulcus
  3. Lesions located at least 1 cm far away from an eloquent area and important subcortical tracts such as pyramidal tract, uncinate fasciculus (preoperatively roughly estimated by MRI and DTI)
  4. Individuals who can accept and complete Stupp regimen therapy after surgery
  5. Karnofsky performance scale (KPS) 70 or more
  6. All patients giving written informed consent.

Exclusion Criteria:

  1. Individuals with age < 18 years or > 80 years
  2. Tumors in eloquent areas, as well as tumors with long invasion (i.e., crossing the corpus callosum) and deep seated tumors (i.e., basal ganglia)
  3. Recurrent gliomas after surgery (except needle biopsy)
  4. Pregnancy or breast-feeding women
  5. Unable to achieve imaging data
  6. Inability to give written informed consent
  7. KPS < 70
  8. Heart insufficiency, lungs insufficiency, renal insufficiency, hepatic insufficiency, autoimmune diseases and other organ diseases with severe dysfunction.

Sites / Locations

  • Department of Neurosurgery , Southwest Hospital, Third Military Medical University,Recruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

total resection

supratotal resection

Arm Description

Removing the parenchyma until signal abnormalities on FLAIR-weighted MR / enhanced-weighted MR in adults with glioma

Extended removing the parenchyma at least 1cm beyond signal abnormalities on FLAIR-weighted MR / enhanced-weighted MR in adults with glioma

Outcomes

Primary Outcome Measures

Progression-free survival (PFS) rates

Secondary Outcome Measures

Volume of resection
Karnofsky performance scale (KPS)

Full Information

First Posted
January 29, 2016
Last Updated
February 4, 2016
Sponsor
Southwest Hospital, China
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1. Study Identification

Unique Protocol Identification Number
NCT02676687
Brief Title
Supratotal Resection for Gliomas Within Noneloquent Areas
Official Title
Supratotal Resection for Gliomas Within Noneloquent Areas: A Single Center Prospective Randomized Controlled Clinical Trial
Study Type
Interventional

2. Study Status

Record Verification Date
February 2016
Overall Recruitment Status
Unknown status
Study Start Date
January 2016 (undefined)
Primary Completion Date
June 2018 (Anticipated)
Study Completion Date
December 2018 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Southwest Hospital, China

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
Gliomas, especially high grade gliomas and diffuse low grade gliomas, are characterized by their infiltrative nature. Recently, a new conception of supratotal resection has been proposed. Given the lack of prospective supporting data, the correlation between supratotal resection and the survival of patients with glioma need to be established. Therefore, the investigators aim to do a single center prospective randomized controlled clinical trial to assess the effect of supratotal resection at least 1 cm beyond the MR imaging-defined abnormalities on progression-free survival (PFS) of glioma.
Detailed Description
It has been demonstrated that an extensive resection (total or subtotal) significantly increases the overall survival in patients with gliomas. Yet, recent data have shown that conventional MR imaging underestimates the spatial extent of gliomas, since tumor cells were found to invade beyond MR imaging abnormalities. Thus, it is hypothesized that an extended resection with a margin beyond MR imaging-defined abnormalities-a "supratotal" resection-might improve the outcome of gliomas. However, the exact extent of supratotal resection remains unclear. Unnecessary removal of brain tissue that does not contain cancer cells can lead to neurological deficits that affect quality of life, such as impaired cognition, memory, and vision. Recently, studies from human specimens have shown that infiltrating glioma cells spread about 1cm beyond the gross and radiographic margins of the tumor. The investigators thereof propose to perform extended resection at least 1cm beyond the MRI defined margin might improve the outcome of patients with gliomas.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Glioma
Keywords
surgery, noneloquent area

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
120 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
total resection
Arm Type
Active Comparator
Arm Description
Removing the parenchyma until signal abnormalities on FLAIR-weighted MR / enhanced-weighted MR in adults with glioma
Arm Title
supratotal resection
Arm Type
Experimental
Arm Description
Extended removing the parenchyma at least 1cm beyond signal abnormalities on FLAIR-weighted MR / enhanced-weighted MR in adults with glioma
Intervention Type
Procedure
Intervention Name(s)
total resection
Intervention Description
Removing the parenchyma until signal abnormalities on FLAIR-weighted MR / enhanced-weighted MR in adults with glioma
Intervention Type
Procedure
Intervention Name(s)
supratotal resection
Intervention Description
Extended removing the parenchyma at least 1cm beyond signal abnormalities on FLAIR-weighted MR / enhanced-weighted MR in adults with glioma
Primary Outcome Measure Information:
Title
Progression-free survival (PFS) rates
Time Frame
2 years
Secondary Outcome Measure Information:
Title
Volume of resection
Time Frame
3 days
Title
Karnofsky performance scale (KPS)
Time Frame
2 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Individuals aged 18-80 years with highly suspected (as assessed by study surgeon), newly diagnosed, untreated glioma Tumor in noneloquent brain areas diagnosed by Head MRI, an eloquent areas is defined according to the recent UCSF (University of California, San Francisco) classification, including the sensor motor areas (precentral and postcentral gyri), perisylvian language areas in the dominant hemisphere (superior temporal, inferior frontal, and inferior parietal gyri), basal ganglia, internal capsule, thalamus, and visual cortex around the calcarine sulcus Lesions located at least 1 cm far away from an eloquent area and important subcortical tracts such as pyramidal tract, uncinate fasciculus (preoperatively roughly estimated by MRI and DTI) Individuals who can accept and complete Stupp regimen therapy after surgery Karnofsky performance scale (KPS) 70 or more All patients giving written informed consent. Exclusion Criteria: Individuals with age < 18 years or > 80 years Tumors in eloquent areas, as well as tumors with long invasion (i.e., crossing the corpus callosum) and deep seated tumors (i.e., basal ganglia) Recurrent gliomas after surgery (except needle biopsy) Pregnancy or breast-feeding women Unable to achieve imaging data Inability to give written informed consent KPS < 70 Heart insufficiency, lungs insufficiency, renal insufficiency, hepatic insufficiency, autoimmune diseases and other organ diseases with severe dysfunction.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Rong Hu, Ph.D
Phone
86-23-68765761
Email
huchrong@aliyun.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Rong Hu, Ph.D
Organizational Affiliation
Southwest Hospital, China
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Hua Feng, Ph.D
Organizational Affiliation
Southwest Hospital, China
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department of Neurosurgery , Southwest Hospital, Third Military Medical University,
City
Chongqing
ZIP/Postal Code
400038
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Rong Hu, MD
Phone
+8615123917123
Email
huchrong@aliyun.com
First Name & Middle Initial & Last Name & Degree
Rong Hu, MD PHD

12. IPD Sharing Statement

Plan to Share IPD
No

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Supratotal Resection for Gliomas Within Noneloquent Areas

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