✓ Translated by DotMD AI Clinical Council Source: JAMA network open • Phase III Randomized Trial
Verify Primary Source: NIH PubMed PMID #40971156 ↗

Phase III Randomized Trial: Chemoradiotherapy With or Without Simultaneous Integrated Boost for Cervical Cancer With Full-Thickness Stromal Invasion (N = 466)

Original Paper Title: “Chemoradiotherapy With or Without Simultaneous Integrated Boost for Cervical Cancer With Full-Thickness Stromal Invasion: A Phase 3 Randomized Clinical Trial”

Elena Rostova (AI Quant) Rigor Score
87 / 100
Sample Size (Participants)
N = 466
Evidence Classification
Phase III Randomized Trial
Sarah Jenkins, RN (AI Plain-English Editor) • Key Takeaways
  • A total of 466 patients with cervical cancer presenting with FT or OFT stromal invasion after radical hysterectomy were randomized (233 in non-SIB radiotherapy group: median age, 53 years [IQR, 46-59 years]; 233 in SIB radiotherapy group: median age, 55 years [IQR, 48-60 years]).
  • Study Design & Sample: Phase III Randomized Trial published in JAMA network open (N = 466 human participants).
  • Biostatistical Rigor Score: 87/100 audited by Elena Rostova (AI Biostatistician & openFDA Quant).

What the Study Found (In Plain English)

Published in JAMA network open (2025), this phase iii randomized trial evaluating 466 human participants investigated: To determine if simultaneous integrated boost (SIB) radiotherapy increases 3-year progression-free survival (PFS) by 13% vs conventional chemoradiotherapy (CRT) among patients with cervical cancer exhibiting FT or OFT stromal invasion after surgery. Key clinical takeaway: A total of 466 patients with cervical cancer presenting with FT or OFT stromal invasion after radical hysterectomy were randomized (233 in non-SIB radiotherapy group: median age, 53 years [IQR, 46-59 years]; 233 in SIB radiotherapy group: median age, 55 years [IQR, 48-60 years]).

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

Primary Endpoint & Quantitative Summary (JAMA network open, 2025-09-02; N = 466; Rigor 87/100): A total of 466 patients with cervical cancer presenting with FT or OFT stromal invasion after radical hysterectomy were randomized (233 in non-SIB radiotherapy group: median age, 53 years [IQR, 46-59 years]; 233 in SIB radiotherapy group: median age, 55 years [IQR, 48-60 years]).

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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