Trial reportPloS one2025
Biweekly CAPOX versus triweekly CAPOX in the adjuvant therapy of post-surgery CRC: A randomized controlled trial.
Trial report in PloS one, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT03564912 (Prospective Study on the Efficacy and Safety of 2 Week or 3 Week Xelox Regimen for Adjuvant Chemotherapy in Colorectal Patients After Surgery), which is not on this map. Not yet cited in PubMed.
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.
Prospective Study on the Efficacy and Safety of 2 Week or 3 Week Xelox Regimen for Adjuvant Chemotherapy in Colorectal Patients After Surgery
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Corrections and comments
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Authors and funding
10 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
purposeThis study aims to compare the safety and efficiency of modified biweekly CAPOX and conventional triweekly CAPOX in high-risk stage II and stage III post-surgery colorectal (CRC) patients.
methodsFrom July 25, 2018, to May 14, 2021, high-risk stage II and stage III post-surgery CRC patients were randomized in the control triweekly group (intravenous infusion of oxaliplatin 130 mg/m2 on day 1 and oral capecitabine 1000 mg/m2, twice daily from day 1 to day 14) and the experimental biweekly group (intravenous infusion of oxaliplatin 85 mg/m2 on day 1 and oral capecitabine 1000 mg/m2, twice daily from day 1 to day 10). The primary endpoint was the incidence rate of thrombocytopenia. The secondary endpoint was 3-year disease free survival (DFS) rate. The patients follow up was started on July 25, 2018, and finished on October 8, 2024.
resultsA total of 160 patients were 1:1 randomly assigned (80 patients to biweekly group and 80 patients to triweekly group). All grade thrombocytopenia occurred in 33% and 49% patients at biweekly and triweekly group, respectively (P = 0.02). Neutropenia presented in 36% and 51% patients at biweekly and triweekly group, respectively (P = 0.04). The second endpoint 3-year DFS was 85.1% in biweekly group and 80.4% in triweekly CAPOX group (P = 0.51, HR = 0.78, [95%CI, 0.38-1.63]). The total rate of uncomplete therapy patient was 7.5% and 15% in biweekly and triweekly group, respectively (P = 0.13).
conclusionBiweekly CAPOX presented significant less thrombocytopenia and neutropenia than triweekly CAPOX regimen. There was no difference in 3-year DFS between biweekly CAPOX and triweekly CAPOX. Clinical trial registration: ClinicalTials.gov (NCT03564912).
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