GliomaNCT02676687
Supratotal Resection for Gliomas Within Noneloquent Areas
A study testing total resection and supratotal resection in people with Glioma, run by Southwest Hospital, China at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Glioma
- What is being tested?
- total resection and supratotal resection
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteChina
- Study dates
- Jan 2016to Dec 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Department of Neurosurgery , Southwest Hospital, Third Military Medical University,
Chongqing, 400038
Rong Hu, MD, +8615123917123, huchrong@aliyun.com
Rong Hu, MD PHD
About this study
Official title: Supratotal Resection for Gliomas Within Noneloquent Areas: A Single Center Prospective Randomized Controlled Clinical Trial
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.
- Conditions
- Glioma
- Being tested
- total resection, supratotal resection
- Keywords
- surgery, noneloquent area
- Medical subject headings
- Glioma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
total resectionProcedure or surgery
Removing the parenchyma until signal abnormalities on FLAIR-weighted MR / enhanced-weighted MR in adults with glioma
supratotal resectionProcedure or surgery
Extended removing the parenchyma at least 1cm beyond signal abnormalities on FLAIR-weighted MR / enhanced-weighted MR in adults with glioma
| Study group | Role | What they receive |
|---|---|---|
| total resection | Active comparator | Removing the parenchyma until signal abnormalities on FLAIR-weighted MR / enhanced-weighted MR in adults with glioma Receives: 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 Receives: Procedure: supratotal resection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression-free survival (PFS) rates
Measured: 2 years
Secondary outcomes (2)
Volume of resection
Measured: 3 days
Karnofsky performance scale (KPS)
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Feb 2016 (estimated)
- Study startJan 2016
- Primary completionJun 2018 (estimated)
- Study completionDec 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for GliomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Southwest Hospital, China
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Rong Hu, Southwest Hospital, China
- Investigators
- Rong Hu, Ph.D, Principal investigator, Southwest Hospital, ChinaHua Feng, Ph.D, Principal investigator, Southwest Hospital, China
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02676687
- Sponsor's protocol ID
- Neurosurg02
- Status last verified
- Feb 2016
- First submitted
- 29 Jan 2016
- Last updated
- 8 Feb 2016
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Feb 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Supratotal Resection for Gliomas Within Noneloquent Areas: A Single Center Prospective Randomized Controlled Clinical Trial
- ClinicalTrials.gov ID
- NCT02676687
- Acronym / sponsor ID
- Neurosurg02
- Conditions
- Glioma
- Keywords
- surgery, noneloquent area
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Southwest Hospital, ChinaUniversity, hospital or other
- Study start
- Jan 2016
- Primary completion
- Jun 2018 (estimated)
- Study completion
- Dec 2018 (estimated)
- First posted
- 8 Feb 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| total resection | Active comparator | Procedure: total resectionRemoving the parenchyma until signal abnormalities on FLAIR-weighted MR / enhanced-weighted MR in adults with glioma |
| supratotal resection | Experimental | Procedure: supratotal resectionExtended removing the parenchyma at least 1cm beyond signal abnormalities on FLAIR-weighted MR / enhanced-weighted MR in adults with glioma |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| total resectionRemoving the parenchyma until signal abnormalities on FLAIR-weighted MR / enhanced-weighted MR in adults with glioma | Procedure or surgery | total resection |
| supratotal resectionExtended removing the parenchyma at least 1cm beyond signal abnormalities on FLAIR-weighted MR / enhanced-weighted MR in adults with glioma | Procedure or surgery | supratotal resection |
Primary outcome
Progression-free survival (PFS) rates
Time frame: 2 years
2 secondary outcomes
Volume of resection
Time frame: 3 days
Karnofsky performance scale (KPS)
Time frame: 2 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Feb 2016.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Rong Hu, Ph.D principal investigator
Southwest Hospital, China
Hua Feng, Ph.D principal investigator
Southwest Hospital, China
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing total resection and supratotal resection in people with Glioma, run by Southwest Hospital, China at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 8 Feb 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Rong Hu, Ph.D (86-23-68765761, huchrong@aliyun.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Progression-free survival (PFS) rates (time frame: 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Feb 2016.