Trial reportBMC medicine2011
A randomized phase III trial of adjuvant chemotherapy with irinotecan, leucovorin and fluorouracil versus leucovorin and fluorouracil for stage II and III colon cancer: a Hellenic Cooperative Oncology Group study.
Trial report in BMC medicine, 2011. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 19 papers.
What it found
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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.
Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.
Who cites it
19 citing papers in PubMed, 50 citations in OpenAlex.
- Circulating tumor DNA-guided de-escalation or escalation of adjuvant therapy in high-risk stage II and stage III colon cancer: the phase 2 PEGASUS trial.Nature cancer · 2026Trial
- Intergroup randomized phase III study of adjuvant FOLFIRI, FOLFOX, or 5-FU/leucovorin for stage II/III rectal cancer: ECOG-ACRIN E3201.The oncologist · 2025Trial
- Neoadjuvant chemoradiotherapy with capecitabine and irinotecan guided by UGT1A1 status in patients with locally advanced rectal cancer: 5-year update of the CinClare trial.Cancer communications (London, England) · 2025Trial
- Impact of Dose Reductions, Delays Between Chemotherapy Cycles, and/or Shorter Courses of Adjuvant Chemotherapy in Stage II and III Colorectal Cancer Patients: a Single-Center Retrospective Study.Journal of gastrointestinal cancer · 2015Trial
- Microsatellite instability and Beta2-Microglobulin mutations as prognostic markers in colon cancer: results of the FOGT-4 trial.British journal of cancer · 2012Trial
- Systemic adjuvant and perioperative chemotherapy following curative-intent liver metastasectomy in colorectal cancer-is it justified?ESMO gastrointestinal oncology · 2025Review
- Postoperative Chemotherapy After Surgical Resection of Metachronous Metastases of Colorectal Cancer: A Systematic Review.World journal of oncology · 2023Review
- The Efficacy of Using Patient-Derived Organoids to Predict Treatment Response in Colorectal Cancer.Cancers · 2023Review
- Clinical and Biological Aspects of Disseminated Tumor Cells and Dormancy in Breast Cancer.Frontiers in cell and developmental biology · 2022Review
- Serious Adverse Events Reporting in Phase III Randomized Clinical Trials of Colorectal Cancer Treatments: A Systematic Analysis.Frontiers in pharmacology · 2021Article
- Adjuvant Chemotherapy for Stage II Colon Cancer.Cancers · 2020Review
- Guidelines for time-to-event end-point definitions in adjuvant randomised trials for patients with localised colon cancer: Results of the DATECAN initiative.European journal of cancer (Oxford, England : 1990) · 2020Article
- Comparison of Drugs Used for Adjuvant and Metastatic Therapy of Colon, Breast, and Non-Small Cell Lung Cancers.JAMA network open · 2020Article
- Making sense of adjuvant chemotherapy in colorectal cancer.Journal of gastrointestinal oncology · 2019Review
- Review
- Adjuvant Chemotherapy of Locally Advanced Colon Cancer: Final Results of a Randomized Trial Comparing 5-Fluorouracil and Folinic Acid with Folfiri.Visceral medicine · 2019Article
- Comprehensive Analysis of miRNome Alterations in Response to Sorafenib Treatment in Colorectal Cancer Cells.International journal of molecular sciences · 2016Article
- MicroRNAs as novel predictive biomarkers and therapeutic targets in colorectal cancer.World journal of gastroenterology · 2014Review
- A review of controversies in the management of colorectal cancers.The Indian journal of surgery · 2012Article
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
26 authors at 12 institutions in 1 country.
Funding
No grant is acknowledged in the PubMed record.
Abstract
backgroundColon cancer is a public health problem worldwide. Adjuvant chemotherapy after surgical resection for stage III colon cancer has been shown to improve both progression-free and overall survival, and is currently recommended as standard therapy. However, its value for patients with stage II disease remains controversial. When this study was designed 5-fluorouracil (5FU) plus leucovorin (LV) was standard adjuvant treatment for colon cancer. Irinotecan (CPT-11) is a topoisomerase I inhibitor with activity in metastatic disease. In this multicenter adjuvant phase III trial, we evaluated the addition of irinotecan to weekly 5FU plus LV in patients with stage II or III colon cancer.
methodsThe study included 873 eligible patients. The treatment consisted of weekly administration of irinotecan 80 mg/m2 intravenously (i.v.), LV 200 mg/m2 and 5FU 450 mg/m2 bolus (Arm A) versus LV 200 mg/m2 and 5FU 500 mg/m2 i.v. bolus (Arm B). In Arm A, treatments were administered weekly for four consecutive weeks, followed by a two-week rest, for a total of six cycles, while in Arm B treatments were administered weekly for six consecutive weeks, followed by a two-week rest, for a total of four cycles. The primary end-point was disease-free survival (DFS) at three years.
resultsThe probability of overall survival (OS) at three years was 0.88 for patients in Arm A and 0.86 for those in Arm B, while the five-year OS probability was 0.78 and 0.76 for patients in Arm A and Arm B, respectively (P = 0.436). Furthermore, the probability of DFS at three years was 0.78 and 0.76 for patients in Arm A and Arm B, respectively (P = 0.334). With the exception of leucopenia and neutropenia, which were higher in patients in Arm A, there were no significant differences in Grades 3 and 4 toxicities between the two regimens. The most frequently recorded Grade 3/4 toxicity was diarrhea in both treatment arms.
conclusionsIrinotecan added to weekly bolus 5FU plus LV did not result in improvement in disease-free or overall survival in stage II or III colon cancer, but did increase toxicity.
trial registrationAustralian New Zealand Clinical Trials Registry: ACTRN12610000148077.
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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.