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Relapse of the whole body is still a major problem of localized advanced rectal cancer.
THE RAPIDO trial was designed to assess the control effect of short course radiotherapy follow-up chemotherapy and delayed surgery on the risk of distant metastasis of advanced rectal cancer.
the trial was a multi-center, open-label, randomized phase 3 trial that recruited primary localized advanced rectal adenocarcinoma patients who had been biopsy-diagnosed at least 18 years of age from 54 centers in several countries.
1:1 randomly divided the subjects into two groups, with the experimental group receiving short course radiotherapy (5×5 Gy, no more than 8 days) →6 courses of CAPOX chemotherapy (capratin, oxalipari) or 9 courses of FOLF OX4 (Osali platinum, folate, high dose of fluorouracil) → whole rectal membrane removal; patients in the standard treatment group received 28×1.8 Gy or 25×2 Gy radiotherapy, while taking capratin daily ornate, and then surgery.
end point is three years of disease-related treatment failures, including local failure, distant metastasis, new primary colorectal tumors, or treatment-related deaths.
June 21, 2011 - June 2, 2016, 920 patients were recruited, 912 of whom met the requirements (462 in the experimental group and 450 in the standard treatment group).
4.6 years (IQR 3.5-5.5).
three years of random grouping, the cumulative rate of disease-related treatment failure in the experimental and standard treatment groups was 23.7% (95% CI 19.8-27.6) vs 30.4% (30.4% 26.1-34.6; Risk ratio of 0.75%, 95% CI 0.60-0.95, p=0.019).
the most common level 3 and above side effects prior to surgery were diarrhea (81 cases in the experimental group (18 per cent) vs 41 cases in the standard group (9 per cent)) and neurotoxicity during complementary chemotherapy (16 cases in the standard group (9 per cent).
severe adverse reactions were found in 177 patients (38%) in the experimental group and 87 (34%) in the standard group who did not undergo complementary chemotherapy, and 64 patients (34%) who did not undergo complementary chemotherapy in the standard group. 4 treatment-related deaths occurred in the
experimental group and the standard group (experimental group: 1 cardiac arrest, 1 pulmonary embolism, 2 infection complications; standard group: 1 pulmonary embolism, 1 neutral granulocyte reduction sepsis, 1 case of missusing, 1 case of suicide caused by severe depression).
in summary, for such patients, the preoperative chemotherapy used by the study group reduced the likelihood of disease-related treatment failure compared to complementary chemotherapy, and the experimental therapy may be considered as a new standard therapy for high-risk local advanced rectal cancer.
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