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Spots Global Cancer Trial Database for Supramarginal Resection in Glioblastoma

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Trial Identification

Brief Title: Supramarginal Resection in Glioblastoma

Official Title: Supramarginal Resection in Patients With Glioblastoma: A Randomised Controlled Trial

Study ID: NCT04243005

Conditions

Glioblastoma

Study Description

Brief Summary: Gliomas are the most common malignant brain tumor. Glioblastoma, WHO grade IV astrocytoma, is the most common subtype and unfortunately also the most aggressive subtype with median survival in population based cohorts being only 10 months. Extensive surgical resections followed by postoperative fractioned radiotherapy and concomitant and adjuvant temozolomide prolong survival and is the standard treatment. The investigators think there is significant potential in individualized surgical decision-making in glioblastoma management. The idea that some patients are amendable to radical surgery, while others should be treated more conservatively, is not controversial in other fields of oncology. The current concept in all patients with glioblastoma is "maximum safe resection of the contrast enhancing tumor", but this may in selected cases be extended to simply "maximum safe resection" tailored to the patient and extent of disease at hand. Densely proliferating tumor cells have been found from at an average of 10 mm beyond the margins of contrast enhancement in high-grade gliomas. There are now several case series, using various definitions of supramarginal resection, but they have in common that they report a benefit of resection with a margin. This potential benefit also comes together with an associated neurological risk, making this approach unethical and simply not feasible in the patients with glioblastoma as a whole. Objective of this study is: To investigate if resection with a margin, that is significantly beyond the radiological contrast enhancement, improves survival in selected patients with glioblastoma.

Detailed Description:

Eligibility

Minimum Age: 18 Years

Eligible Ages: ADULT, OLDER_ADULT

Sex: ALL

Healthy Volunteers: No

Locations

Medical University of Vienna, Vienna, , Austria

Odense University Hospital, Odense, , Denmark

Helsinki University Hospital, Helsinki, , Finland

Kuopio University Hospital, Kuopio, , Finland

Oulu University Hospital, Oulu, , Finland

Tampere University Hospital, Tampere, , Finland

Turku University Hospital, Turku, , Finland

Haukeland University Hospital, Bergen, , Norway

Oslo University Hospital, Rikshospitalet, Oslo, , Norway

Ullevål University Hospital, Oslo, , Norway

University Hospital North Norway, Tromsø, , Norway

St Olavs Hospital, Trondheim, , Norway

Sahlgrenska University Hospital,, Göteborg, , Sweden

Linköping University Hospital, Linköping, , Sweden

Skåne University Hospital, Lund, , Sweden

Karolinska University Hospital, Stockholm, , Sweden

University Hospital of Umeå, Umeå, , Sweden

Uppsala University Hospital, Uppsala, , Sweden

Contact Details

Name: Asgeir S Jakola, MD, PhD

Affiliation: St.Olavs University Hospital and Sahlgrenska University Hospital

Role: PRINCIPAL_INVESTIGATOR

Name: Geir Bråthen, MD, PhD

Affiliation: St. Olavs Hospital

Role: STUDY_DIRECTOR

Useful links and downloads for this trial

Clinicaltrials.gov

Google Search Results

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