{"entity":{"id":"interaact","kind":"trial","name":"InterAACT","aka":["InterAAct","IRCI InterAACT","EA2133"],"tldr":"InterAACT was the first randomised trial ever run in advanced anal cancer; the two chemotherapy pairs shrank tumours equally often, but carboplatin with paclitaxel caused far fewer serious side effects and patients on it lived longer, so it became the standard chemotherapy backbone.","summary":"InterAACT was an international randomised phase 2 trial of the International Rare Cancers Initiative, led from the Royal Marsden with ECOG-ACRIN, AGITG and EORTC partners, in 91 patients with chemotherapy-naive advanced anal squamous cell carcinoma randomised to cisplatin plus fluorouracil or carboplatin plus weekly paclitaxel. The primary endpoint was best overall response rate by 24 weeks.\n\nResponse rates were the same (57 against 59 percent), but serious adverse events were more frequent with cisplatin-fluorouracil (62 against 36 percent), median progression-free survival was 5.7 against 8.1 months and median overall survival 12.3 against 20 months (hazard ratio 2.00 for cisplatin-fluorouracil). Carboplatin-paclitaxel became the reference regimen and the chemotherapy backbone of POD1UM-303, which is how the corpus's metastatic anal cancer page cites it.","status":"positive","asOf":"2026-09-22","links":[{"label":"ClinicalTrials.gov NCT02051868","url":"https://clinicaltrials.gov/study/NCT02051868"},{"label":"ClinicalTrials.gov NCT02560298","url":"https://clinicaltrials.gov/study/NCT02560298"}],"tags":["soc-trials"],"related":[],"cancers":["metastatic-anal-cancer","anal"],"sections":[],"technologies":["cytotoxic-chemotherapy"],"targets":[],"drugs":["carboplatin","paclitaxel","cisplatin","fluorouracil"],"companies":[],"institutions":["royal-marsden","ecog-acrin"],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":["paper-interaact-carboplatin-paclitaxel-advanced-anal-cancer-rao-jco-2020"],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT02051868","phase":"2","setting":"Chemotherapy-naive inoperable locally recurrent or metastatic anal squamous cell carcinoma at 60 centres through the International Rare Cancers Initiative: cisplatin plus fluorouracil against carboplatin plus weekly paclitaxel, with best overall response rate by 24 weeks as the primary endpoint","sponsor":"Royal Marsden NHS Foundation Trust","result":"Response rate 57 percent with cisplatin-fluorouracil against 59 percent with carboplatin-paclitaxel; serious adverse events 62 against 36 percent; median overall survival 12.3 against 20 months (hazard ratio 2.00, p 0.014).","yearReported":2020,"enrolled":91,"enrolledBasis":"randomised","enrolledNote":"The UK registry record gives an estimated 80 and the ECOG-ACRIN companion record (NCT02560298, EA2133) 91; the Journal of Clinical Oncology report randomised 91 patients across both (46 to cisplatin-fluorouracil, 45 to carboplatin-paclitaxel).","outcomes":[{"endpoint":"Best overall response rate by 24 weeks","primary":true,"unit":"%","arms":[{"name":"Carboplatin + weekly paclitaxel","n":45,"value":59,"note":"95% CI 42.1 to 74.4"},{"name":"Cisplatin + fluorouracil","n":46,"value":57,"note":"95% CI 39.4 to 73.7"}],"source":"https://doi.org/10.1200/JCO.19.03266"},{"endpoint":"Overall survival","unit":"months","arms":[{"name":"Carboplatin + weekly paclitaxel","n":45,"value":20,"note":"95% CI 12.7 to not reached"},{"name":"Cisplatin + fluorouracil","n":46,"value":12.3,"note":"95% CI 9.2 to 17.7"}],"hr":2,"ci":[1.15,3.47],"p":"0.014","source":"https://doi.org/10.1200/JCO.19.03266"},{"endpoint":"Progression-free survival","unit":"months","arms":[{"name":"Carboplatin + weekly paclitaxel","n":45,"value":8.1,"note":"95% CI 6.6 to 8.8"},{"name":"Cisplatin + fluorouracil","n":46,"value":5.7,"note":"95% CI 3.3 to 9.0"}],"source":"https://doi.org/10.1200/JCO.19.03266"},{"endpoint":"Serious adverse events","unit":"%","arms":[{"name":"Carboplatin + weekly paclitaxel","n":45,"value":36},{"name":"Cisplatin + fluorouracil","n":46,"value":62}],"p":"0.016","source":"https://doi.org/10.1200/JCO.19.03266"}]},"route":"/trials/interaact/","neighbours":{"cancer":[{"id":"anal","kind":"cancer","name":"Anal cancer (squamous cell carcinoma)","route":"/cancers/anal/"},{"id":"metastatic-anal-cancer","kind":"cancer","name":"Metastatic and recurrent anal squamous cell carcinoma","route":"/cancers/metastatic-anal-cancer/"}],"technology":[{"id":"cytotoxic-chemotherapy","kind":"technology","name":"Cytotoxic chemotherapy","route":"/technologies/cytotoxic-chemotherapy/"}],"drug":[{"id":"carboplatin","kind":"drug","name":"Carboplatin","route":"/drugs/carboplatin/"},{"id":"cisplatin","kind":"drug","name":"Cisplatin","route":"/drugs/cisplatin/"},{"id":"fluorouracil","kind":"drug","name":"Fluorouracil (5-FU)","route":"/drugs/fluorouracil/"},{"id":"paclitaxel","kind":"drug","name":"Paclitaxel / nab-paclitaxel","route":"/drugs/paclitaxel/"}],"institution":[{"id":"ecog-acrin","kind":"institution","name":"ECOG-ACRIN Cancer Research Group","route":"/institutions/ecog-acrin/"},{"id":"royal-marsden","kind":"institution","name":"The Royal Marsden","route":"/institutions/royal-marsden/"}],"paper":[{"id":"paper-interaact-carboplatin-paclitaxel-advanced-anal-cancer-rao-jco-2020","kind":"paper","name":"InterAACT: cisplatin and fluorouracil versus carboplatin and paclitaxel in advanced anal cancer","route":"/key-papers/paper-interaact-carboplatin-paclitaxel-advanced-anal-cancer-rao-jco-2020/"}]}}