A phase II pilot randomized controlled trial to assess the feasibility of the “supra-marginal” surgical resection of malignant glioma (G-SUMIT: Glioma supra marginal incision trial) study protocol
Bibliographic record
Abstract
BACKGROUND: 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 gadolinium (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 2-cm region surrounding the original GAD-enhancing margin. However, this must be weighed against the risk of potential damage to functional brain tissue. METHODS: In this phase II pilot randomized control trial (RCT), we aim to assess the feasibility of "supra-marginal" resection extending 1 cm beyond the enhancing tumor in adults with radiographic evidence of GAD-enhancing intra-axial tumor consistent with high-grade glioma in a safe anatomical location and a Karnofsky Performance Score > 60. With six academic institutions with established neurosurgical oncology practices in participation, we aim to enroll 72 patients over 2 years. Primary outcomes include evaluating the feasibility of performing a large-scale trial with regard 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 (Modified Rankin Scale (mRS), EuroQol-5D (ED-5D), 30-day all-cause mortality). DISCUSSION: Recent studies have revealed survival advantages comparing supra-marginal resection to standard attempt at gross total resection (GTR) with no additional perioperative surgical risk; however, the current quality of evidence is low and under-powered. Therefore, there are no current practice guidelines, and the philosophy of surgical resection is guided by individual surgeon preferences on an individual patient basis. This creates additional uncertainty and is potentially detrimental to our patients. This clinical equipoise supports the need for an adequately powered RCT to determine whether a supra-marginal resection can have a positive impact on survival for patients with HGGs. Our pilot RCT will test the feasibility of comparing the standard gross total resection of GAD-enhancing tumors and supra-marginal resection to prepare for a larger definitive multicenter RCT. TRIAL REGISTRATION: ClinicalTrials.gov , NCT04737577. Registered on February 4, 2021.
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How this classification was reachedexpand
Full frame distilled prediction
Teacher imitationNot calibrated prevalence, not ground truth. Human validation pending. Learned from the 10,348 direct Codex labels and 10,348 direct Gemma labels. Candidate is the union of thresholded teacher heads; consensus is their intersection. These outputs are machine_predicted_unvalidated and are not human labels or direct frontier model labels.
Codex and Gemma teacher scores by category
| Category | Codex | Gemma |
|---|---|---|
| Metaresearch | 0.013 | 0.005 |
| Meta-epidemiology (narrow) | 0.001 | 0.000 |
| Meta-epidemiology (broad) | 0.004 | 0.001 |
| Bibliometrics | 0.000 | 0.001 |
| Science and technology studies | 0.001 | 0.001 |
| Scholarly communication | 0.000 | 0.000 |
| Open science | 0.000 | 0.001 |
| Research integrity | 0.000 | 0.000 |
| Insufficient payload (model declined to judge) | 0.000 | 0.000 |
Machine scores (provisional)
The two teacher heads of the student model, read on this work. A score orders the frame for review; it never asserts a category, and the validation status ships verbatim with every row.
Baseline scores from an immature model (maturity gate not passed, 7 training rounds). Scores rank; they never assert a category.
score_only:v0-immature-baseline · verbatim from the scoring run: score_only means the number may rank works, and no category label ships from itClassification
machine, unvalidatedMachine predicted; a candidate call from one teacher head, not a consensus.
How this classification was reached, model by model and score by score, is at the end of the page under "How this classification was reached".