Trial reportJAMA2012
Effect of oxaliplatin, fluorouracil, and leucovorin with or without cetuximab on survival among patients with resected stage III colon cancer: a randomized trial.
Trial report in JAMA, 2012. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT00079274 (A Randomized Phase III Trial of Oxaliplatin), which is not on this map. Cited by 228 papers, 15 of them syntheses that pooled it.
What it found
Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.
The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
A Randomized Phase III Trial of Oxaliplatin (OXAL) Plus 5-Fluorouracil (5-FU)/Leucovorin (CF) With or Without Cetuximab (C225) After Curative Resection for Patients With Stage III Colon Cancer
Who cites it
228 citing papers in PubMed, 15 syntheses or guidelines pooled it, 493 citations in OpenAlex.
- Risk of high-grade infections in colorectal cancer patients treated with anti-EGFR monoclonal antibodies: a meta-analysis of randomized controlled trials.Frontiers in oncology · 2026Pooled it
- SEOM-GEMCAD-TTD clinical guidelines for the adjuvant treatment of colon cancer (2023).Clinical & translational oncology : official publication of the Federation of Spanish Oncology Societies and of the National Cancer Institute of Mexico · 2024Guideline
- KRAS and BRAF Mutations in Stage II and III Colon Cancer: A Systematic Review and Meta-Analysis.Journal of the National Cancer Institute · 2022Pooled it
- Neoadjuvant chemotherapy in locally advanced colon cancer: a systematic review.Techniques in coloproctology · 2020Pooled it
- Lessons learnt from scoring adjuvant colon cancer trials and meta-analyses using the ESMO-Magnitude of Clinical Benefit Scale V.1.1.ESMO open · 2020Pooled it
- Pooled it
- Prognostic factors of adjuvant chemotherapy discontinuation among stage III colon cancer patients: A survey of medical oncologists and a systematic review and meta-analysis.Cancer medicine · 2020Pooled it
- Risk of fatigue in cancer patients receiving anti-EGFR monoclonal antibodies: results from a systematic review and meta-analysis of randomized controlled trial.International journal of clinical oncology · 2018Pooled it
- The role of targeted agents in the adjuvant treatment of colon cancer: a meta-analysis of randomized phase III studies and review.Oncotarget · 2017Pooled it
- Adjuvant chemotherapy for resected colorectal cancer metastases: Literature review and meta-analysis.World journal of gastroenterology · 2016Pooled it
- Pooled it
- Standard chemotherapy with cetuximab for treatment of colorectal cancer.World journal of gastroenterology · 2015Pooled it
- Electrolyte disorders assessment in solid tumor patients treated with anti-EGFR monoclonal antibodies: a pooled analysis of 25 randomized clinical trials.Tumour biology : the journal of the International Society for Oncodevelopmental Biology and Medicine · 2015Pooled it
- Efficacy and toxicity of adding cetuximab to chemotherapy in the treatment of metastatic colorectal cancer: a meta-analysis from 12 randomized controlled trials.Tumour biology : the journal of the International Society for Oncodevelopmental Biology and Medicine · 2014Pooled it
- Pooled it
- Trial
- Tissue-Free Circulating Tumor DNA Assay and Patient Outcome in a Phase III Trial of FOLFOX-Based Adjuvant Chemotherapy (Alliance N0147).Journal of clinical oncology : official journal of the American Society of Clinical Oncology · 2026Trial
- Atezolizumab plus FOLFOX for Stage III Mismatch Repair-Deficient Colon Cancer.The New England journal of medicine · 2026Trial
- Negative hyperselection of patients with stage III colon cancer receiving anti-EGFR-based adjuvant treatment.ESMO open · 2025Trial
- Preoperative Chemotherapy for Operable Colon Cancer: Mature Results of an International Randomized Controlled Trial.Journal of clinical oncology : official journal of the American Society of Clinical Oncology · 2023Trial
168 more citing papers are in PubMed but not listed here.
Corrections and comments
- Commented on by
Authors and funding
18 authors at 1 institution in 1 country.
Funding
Abstract
contextLeucovorin, fluorouracil, and oxaliplatin (FOLFOX) is the standard adjuvant therapy for resected stage III colon cancer. Adding cetuximab to FOLFOX benefits patients with metastatic wild-type KRAS but not mutated KRAS colon cancer.
objectiveTo assess the potential benefit of cetuximab added to the modified sixth version of the FOLFOX regimen (mFOLFOX6) in patients with resected stage III wild-type KRAS colon cancer. DESIGN, SETTING, AND
participantsA randomized trial of 2686 patients aged 18 years or older at multiple institutions across North America enrolled following resection and informed consent between February 10, 2004, and November 25, 2009. The primary randomized comparison was 12 biweekly cycles of mFOLFOX6 with and without cetuximab. KRAS mutation status was centrally determined. The trial was halted after a planned interim analysis of 48% of predicted events (246/515) occurring in 1863 (of 2070 planned) patients with tumors having wild-type KRAS. A total of 717 patients with mutated KRAS and 106 with indeterminate KRAS were accrued. The 2070 patients with wild-type KRAS provided 90% power to detect a hazard ratio (HR) of 1.33 (2-sided α = .05), with planned interim efficacy analyses after 25%, 50%, and 75% of expected relapses.
main outcome measuresDisease-free survival in patients with wild-type KRAS mutations. Secondary end points included overall survival and toxicity.
resultsMedian (range) follow-up was 28 (0-68) months. The trial demonstrated no benefit when adding cetuximab. Three-year disease-free survival for mFOLFOX6 alone was 74.6% vs 71.5% with the addition of cetuximab (HR, 1.21; 95% CI, 0.98-1.49; P = .08) in patients with wild-type KRAS, and 67.1% vs 65.0% (HR, 1.12; 95% CI, 0.86-1.46; P = .38) in patients with mutated KRAS, with no significant benefit in any subgroups assessed. Among all patients, grade 3 or higher adverse events (72.5% vs 52.3%; odds ratio [OR], 2.4; 95% CI, 2.1-2.8; P < .001) and failure to complete 12 cycles (33% vs 23%; OR, 1.6; 95% CI, 1.4-1.9; P < .001) were significantly higher with cetuximab. Increased toxicity and greater detrimental differences in all outcomes were observed in patients aged 70 years or older.
conclusionAmong patients with stage III resected colon cancer, the use of cetuximab with adjuvant mFOLFOX6 compared with mFOLFOX6 alone did not result in improved disease-free survival.
trial registrationclinicaltrials.gov Identifier: NCT00079274.
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Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.