✓ Translated by DotMD AI Clinical Council Source: Journal of clinical oncology : official journal of the American Society of Clinical Oncology • Phase III Randomized Trial
Verify Primary Source: NIH PubMed PMID #34520230 ↗

Phase III Randomized Trial: Hepatectomy Followed by mFOLFOX6 Versus Hepatectomy Alone for Liver-Only Metastatic Colorectal Cancer (JCOG0603) (N = 300)

Original Paper Title: “Hepatectomy Followed by mFOLFOX6 Versus Hepatectomy Alone for Liver-Only Metastatic Colorectal Cancer (JCOG0603): A Phase II or III Randomized Controlled Trial”

Elena Rostova (AI Quant) Rigor Score
87 / 100
Sample Size (Participants)
N = 300
Evidence Classification
Phase III Randomized Trial
Sarah Jenkins, RN (AI Plain-English Editor) • Key Takeaways
  • DFS did not correlate with OS for liver-only metastatic CRC. Adjuvant chemotherapy with mFOLFOX6 improves DFS among patients treated with hepatectomy for CRC liver metastasis. It remains unclear whether chemotherapy improves OS.
  • Study Design & Sample: Phase III Randomized Trial published in Journal of clinical oncology : official journal of the American Society of Clinical Oncology (N = 300 human participants).
  • Biostatistical Rigor Score: 87/100 audited by Elena Rostova (AI Biostatistician & openFDA Quant).

What the Study Found (In Plain English)

Published in Journal of clinical oncology : official journal of the American Society of Clinical Oncology (2021), this phase iii randomized trial evaluating 300 human participants investigated: Adjuvant chemotherapy after hepatectomy is controversial in liver-only metastatic colorectal cancer (CRC). Key clinical takeaway: DFS did not correlate with OS for liver-only metastatic CRC. Adjuvant chemotherapy with mFOLFOX6 improves DFS among patients treated with hepatectomy for CRC liver metastasis. It remains unclear whether chemotherapy improves OS.

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

Primary Endpoint & Quantitative Summary (Journal of clinical oncology : official journal of the American Society of Clinical Oncology, 2021-12-01; N = 300; Rigor 87/100): DFS did not correlate with OS for liver-only metastatic CRC. Adjuvant chemotherapy with mFOLFOX6 improves DFS among patients treated with hepatectomy for CRC liver metastasis. It remains unclear whether chemotherapy improves OS.

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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