IOTG-02. Glioma Supra Marginal Incision Trial (G-SUMIT): a phase II pilot randomized control trial to assess the feasibility of “supra-marginal” surgical resection of malignant glioma

Abstract

Abstract High grade gliomas are the most common primary malignant brain tumor in adults having a median survival of only 13–16 months. This is despite the current standard of maximal safe surgical resection followed by fractionated radiotherapy and chemotherapy. Extending the tumor resection limit beyond the GAD-enhancing margin (i.e. supra-marginal resection) could in principle provide an added survival benefit as it has been shown that >80% of post-operative tumor recurrence is within a 2cm region surrounding the original GAD-enhancing margin. However, this must be weighed against the risk of potential damage to functional brain tissue. In this phase II pilot randomized control trial (RCT), we aim to assess the feasibility of “supra-marginal” resection extending 1cm beyond the enhancing tumor in adults with radiographic evidence of GAD-enhancing intra-axial tumour consistent with high grade glioma in a safe anatomical location and a Karnofsky Performance Score > 60. With six academic centres participating, we aim to enroll 72 patients over two years. Currently, four patients have already been enrolled in the first four months. Primary outcomes include evaluating the feasibility of performing a large-scale trial with regards to recruitment, allocation and outcome documentation as well as safety data. Secondary outcomes include determining if there is an increased survival benefit with supra-marginal resection and impact on quality of life. Our pilot RCT will test the feasibility of comparing standard gross total resection of GAD-enhancing tumour and supra-marginal resection to prepare for a larger definitive multicentre RCT.