NCT02676687

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
120

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jan 2016

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2016

Completed
28 days until next milestone

First Submitted

Initial submission to the registry

January 29, 2016

Completed
10 days until next milestone

First Posted

Study publicly available on registry

February 8, 2016

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2018

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2018

Completed
Last Updated

February 8, 2016

Status Verified

February 1, 2016

Enrollment Period

2.4 years

First QC Date

January 29, 2016

Last Update Submit

February 4, 2016

Conditions

Glioma

Keywords

surgery, noneloquent area

Outcome Measures

Primary Outcomes (1)

  • Progression-free survival (PFS) rates

    2 years

Secondary Outcomes (2)

  • Volume of resection

    3 days

  • Karnofsky performance scale (KPS)

    2 years

Study Arms (2)

total resection

ACTIVE COMPARATOR

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

Procedure: total resection

supratotal resection

EXPERIMENTAL

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

Procedure: supratotal resection

Interventions

total resectionPROCEDURE

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

total resection
supratotal resectionPROCEDURE

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

supratotal resection

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

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

Chongqing, 400038, China

RECRUITING

MeSH Terms

Conditions

Glioma

Condition Hierarchy (Ancestors)

Neoplasms, NeuroepithelialNeuroectodermal TumorsNeoplasms, Germ Cell and EmbryonalNeoplasms by Histologic TypeNeoplasmsNeoplasms, Glandular and EpithelialNeoplasms, Nerve Tissue

Study Officials

  • Rong Hu, Ph.D

    Southwest Hospital, China

    PRINCIPAL INVESTIGATOR

  • Hua Feng, Ph.D

    Southwest Hospital, China

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Rong Hu, Ph.D

CONTACT

86-23-68765761huchrong@aliyun.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor, Associate Chief Neurosurgeon

Study Record Dates

First Submitted

January 29, 2016

First Posted

February 8, 2016

Study Start

January 1, 2016

Primary Completion

June 1, 2018

Study Completion

December 1, 2018

Last Updated

February 8, 2016

Record last verified: 2016-02

Data Sharing

IPD Sharing
Will not share

Locations

CN(1)