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Status unknownNCT02676687Updated Feb 8, 2016

Supratotal Resection for Gliomas Within Noneloquent Areas

An interventional study of total resection and supratotal resection in Glioma, sponsored by Southwest Hospital, China. Status unknown at 1 site in China. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2016-02-08.

Sponsored by Southwest Hospital, China · Not applicable, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Feb 2016), so the status shown — last known as Recruiting — may be out of date.
Phase
Not applicable
Study type
Interventional
Enrollment
120
Allocation
Randomized
Ages
18 Years to 80 Years
Sex
All
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Study 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.

Read the 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.

02

Conditions studied

  • Glioma

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Keywords

  • surgery, noneloquent area
03

In context

Glioma

1,425 studies on the registry are indexed under Glioma; 355 are open to participants now.

This study's planned enrollment of 120 is above the median of 32 across 1,085 interventional studies indexed under Glioma.

Browse Glioma studies →

Lead sponsor

Southwest Hospital, China is the lead sponsor of 87 studies on the registry; 16 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 80 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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.
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Outcomes assessor)
Enrollment
120 participants (estimated)

Study arms

  • Active comparator
    total resection

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

    Procedure: total resection

  • Experimental
    supratotal resection

    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

  • Proceduretotal resection

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

  • Proceduresupratotal resection

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

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What researchers measure

Primary outcomes

  1. Progression-free survival (PFS) rates

    Time frame: 2 years

Secondary outcomes

  1. Volume of resection

    Time frame: 3 days

  2. Karnofsky performance scale (KPS)

    Time frame: 2 years

07

Study locations

1 of 1 sites recruiting
  • Department of Neurosurgery , Southwest Hospital, Third Military Medical University,
    Chongqing, 400038, China
    • Rong Hu, MD · Contact · huchrong@aliyun.com · +8615123917123
    • Rong Hu, MD PHD · Principal investigator
    Recruiting
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
Not marked actual or estimatedDates not marked actual or estimated

The record gives a start of Jan 2016, a primary completion of Jun 2018 and a completion of Dec 2018. It does not say whether these dates are actual or estimated.

How these figures are worked out, and which studies are left out of them.

Registered
Jan 29, 2016
First posted
Feb 8, 2016
Start
Jan 2016
Primary completionEst.
Jun 2018
CompletionEst.
Dec 2018
Last update
Feb 8, 2016
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Feb 8, 2016, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT02676687
Lead sponsor
Southwest Hospital, China
Responsible party
Rong Hu (Associate Professor, Associate Chief Neurosurgeon, Southwest Hospital, China) — Principal investigator
First posted
Feb 8, 2016
Start date
Jan 2016
Primary completion
Jun 2018 (estimated)
Completion
Dec 2018 (estimated)
Last update
Feb 8, 2016

Study contacts

Rong Hu, Ph.D
Contact
huchrong@aliyun.com
86-23-68765761
Rong Hu, Ph.D
principal investigator · Southwest Hospital, China
Hua Feng, Ph.D
principal investigator · Southwest Hospital, China

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Feb 2016. You cannot join it, but the record below documents what was studied.

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