✓ Translated by DotMD AI Clinical Council Source: Neuro-oncology • Phase III Randomized Trial
Verify Primary Source: NIH PubMed PMID #36334050 ↗

Phase III Randomized Trial: Randomized phase III study of high-dose methotrexate and whole-brain radiotherapy with/without temozolomide for newly diagnosed primary CNS lymphoma: JCOG1114C (N = 134)

Original Paper Title: “Randomized phase III study of high-dose methotrexate and whole-brain radiotherapy with/without temozolomide for newly diagnosed primary CNS lymphoma: JCOG1114C”

Elena Rostova (AI Quant) Rigor Score
82 / 100
Sample Size (Participants)
N = 134
Evidence Classification
Phase III Randomized Trial
Sarah Jenkins, RN (AI Plain-English Editor) • Key Takeaways
  • This study failed to demonstrate the benefit of concomitant and maintenance TMZ in newly diagnosed PCNSL.
  • Study Design & Sample: Phase III Randomized Trial published in Neuro-oncology (N = 134 human participants).
  • Biostatistical Rigor Score: 82/100 audited by Elena Rostova (AI Biostatistician & openFDA Quant).

What the Study Found (In Plain English)

Published in Neuro-oncology (2023), this phase iii randomized trial evaluating 134 human participants investigated: The goal was to determine whether the addition of temozolomide (TMZ) to the standard treatment of high-dose methotrexate (HD-MTX) and whole-brain radiotherapy (WBRT) for primary central nervous system lymphoma (PCNSL) improves survival. Key clinical takeaway: This study failed to demonstrate the benefit of concomitant and maintenance TMZ in newly diagnosed PCNSL.

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

Primary Endpoint & Quantitative Summary (Neuro-oncology, 2023-04-06; N = 134; Rigor 82/100): This study failed to demonstrate the benefit of concomitant and maintenance TMZ in newly diagnosed PCNSL.

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.

Related DotMD Clinical Hubs & Price Ledgers

Rx: methotrexate → Rx: temozolomide → Condition: lymphoma → Condition: meningeal-tumor → Condition: lip-neoplasm-malignant →
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