✓ Translated by DotMD AI Clinical Council Source: Radiotherapy and oncology : journal of the European Society for Therapeutic Radiology and Oncology • Phase III Randomized Trial
Verify Primary Source: NIH PubMed PMID #40796015 ↗

Phase III Randomized Trial: Quality assurance in the randomized multicentre phase III trial EORTC-1709-BTG/CCTG CE.8 (MIRAGE) for glioblastoma: Results of the radiotherapy delineation benchmark case procedure (N = 70)

Original Paper Title: “Quality assurance in the randomized multicentre phase III trial EORTC-1709-BTG/CCTG CE.8 (MIRAGE) for glioblastoma: Results of the radiotherapy delineation benchmark case procedure”

Elena Rostova (AI Quant) Rigor Score
82 / 100
Sample Size (Participants)
N = 70
Evidence Classification
Phase III Randomized Trial
Sarah Jenkins, RN (AI Plain-English Editor) • Key Takeaways
  • Variations in the delineation of target volumes and organs at risk were frequently judged as "unacceptable" during the RTQA review process. Besides a significant increase of CTV coverage, the impact of variations on organ at risk dosimetry was minor, suggesting a potentially negligible effect on toxicity outcomes.
  • Study Design & Sample: Phase III Randomized Trial published in Radiotherapy and oncology : journal of the European Society for Therapeutic Radiology and Oncology (N = 70 human participants).
  • Biostatistical Rigor Score: 82/100 audited by Elena Rostova (AI Biostatistician & openFDA Quant).

What the Study Found (In Plain English)

Published in Radiotherapy and oncology : journal of the European Society for Therapeutic Radiology and Oncology (2025), this phase iii randomized trial evaluating 70 human participants investigated: The multicentre randomised phase III trial EORTC-1709-BTG/CCTG CE.8 (MIRAGE) (NCT03345095) analysed the addition of the proteasome inhibitor marizomib to temozolomide-based chemoradiotherapy with 60 Gy in 30 fractions in patients with newly diagnosed glioblastoma. Key clinical takeaway: Variations in the delineation of target volumes and organs at risk were frequently judged as "unacceptable" during the RTQA review process. Besides a significant increase of CTV coverage,...

Dr. Lin (AI Evidence Lead): Statistical Endpoints & Numbers

Primary Endpoint & Quantitative Summary (Radiotherapy and oncology : journal of the European Society for Therapeutic Radiology and Oncology, 2025-10-15; N = 70; Rigor 82/100): Variations in the delineation of target volumes and organs at risk were frequently judged as "unacceptable" during the RTQA review process. Besides a significant increase of CTV coverage, the impact of variations on organ at risk dosimetry was minor, suggesting a potentially negligible effect on toxicity outcomes.

Study Limitations & Caveats Before You Act

Clinical trials evaluate specific inclusion/exclusion cohorts under protocol-controlled conditions (Phase III Randomized Trial). Individual response, hepatic/renal clearance, CYP450 drug interactions, and baseline comorbidities vary; verify applicability with a board-certified physician before modifying any prescription or supplement regimen.

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