Supratotal Resection for Gliomas Within Noneloquent Areas

Glioma Clinical Trial

Official title:

Supratotal Resection for Gliomas Within Noneloquent Areas: A Single Center Prospective Randomized Controlled Clinical Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02676687
• Other study ID #: Neurosurg02
• Status: Recruiting
• Phase: N/A
• First received: January 29, 2016
• Last updated: February 4, 2016
• Start date: January 2016
• Est. completion date: December 2018

Study information

• Verified date: February 2016
• Source: Southwest Hospital, China
• Contact: Rong Hu, Ph.D
• Phone: 86-23-68765761
• Email: huchrong[@]aliyun.com
• Is FDA regulated: No
• Health authority: China: Food and Drug Administration
• Study type: Interventional

Clinical 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. 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 120
• Est. completion date: December 2018
• Est. primary completion date: June 2018
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Glioma

Intervention

Procedure:
• total resection
Removing the parenchyma until signal abnormalities on FLAIR-weighted MR / enhanced-weighted MR in adults with glioma
• supratotal resection
Extended removing the parenchyma at least 1cm beyond signal abnormalities on FLAIR-weighted MR / enhanced-weighted MR in adults with glioma

Locations

Country	Name	City	State
China	Department of Neurosurgery , Southwest Hospital, Third Military Medical University,	Chongqing

Sponsors (1)

Lead Sponsor	Collaborator
Southwest Hospital, China

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Progression-free survival (PFS) rates		2 years	Yes
Secondary	Volume of resection		3 days	No
Secondary	Karnofsky performance scale (KPS)		2 years	Yes