{"entity":{"id":"isg-sts-1001","kind":"trial","name":"ISG-STS 1001","aka":[],"tldr":"Standard anthracycline-ifosfamide before surgery beat subtype-tailored chemotherapy, and indirectly showed neoadjuvant chemotherapy helps high-risk sarcoma.","summary":"ISG-STS 1001, trial NCT01710176 sponsored by the Italian Sarcoma Group and published in Lancet Oncology in 2017, found that standard neoadjuvant epirubicin and ifosfamide beat subtype-tailored chemotherapy in high-risk localised soft-tissue sarcoma of the extremities and trunk, and indirectly showed that neoadjuvant chemotherapy helps in this setting. It randomised 287 patients and was stopped early when disease-free and overall survival at 46 months favoured the standard arm, and long-term follow-up confirmed the benefit against historical controls, establishing three cycles of neoadjuvant anthracycline and ifosfamide for grade 3, deep tumours over five centimetres. Whether tailored regimens fail because the histotypes were wrong or the drugs were weaker is the open question.","status":"positive","asOf":"2026-09-07","links":[{"label":"ClinicalTrials.gov NCT01710176","url":"https://clinicaltrials.gov/study/NCT01710176"}],"tags":[],"related":[],"cancers":["sarcoma","extremity-soft-tissue-sarcoma","undifferentiated-pleomorphic-sarcoma"],"sections":[],"technologies":["cytotoxic-chemotherapy"],"targets":[],"drugs":["ifosfamide"],"companies":["italian-sarcoma-group"],"institutions":[],"pathways":[],"terms":["fnclcc-grade","sarcoma-histotype-tailoring"],"trials":[],"people":["alessandro-gronchi"],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT01710176","phase":"3","setting":"High-risk localised soft-tissue sarcoma of extremities/trunk: neoadjuvant epirubicin-ifosfamide vs histotype-tailored chemotherapy","sponsor":"Italian Sarcoma Group","result":"Standard arm DFS HR ~0.45 vs tailored; OS 89% vs 64% at 46 months.","started":"2011-06-01","startedType":"actual","yearReported":2017,"enrolled":287,"enrolledBasis":"registry","outcomes":[{"endpoint":"Overall survival at 46 months","unit":"%","arms":[{"name":"Epirubicin-ifosfamide","n":142,"value":89},{"name":"Histotype-tailored","n":145,"value":64,"note":"HR for death 2.687 (tailored vs standard)"}],"source":"https://www.thelancet.com/journals/lanonc/article/PIIS1470-2045(17)30334-0/fulltext"}]},"route":"/trials/isg-sts-1001/","neighbours":{"cancer":[{"id":"sarcoma","kind":"cancer","name":"Sarcomas (soft tissue, bone, GIST)","route":"/cancers/sarcoma/"},{"id":"extremity-soft-tissue-sarcoma","kind":"cancer","name":"Soft tissue sarcoma of the extremity (localised and advanced)","route":"/cancers/extremity-soft-tissue-sarcoma/"},{"id":"undifferentiated-pleomorphic-sarcoma","kind":"cancer","name":"Undifferentiated pleomorphic sarcoma (UPS)","route":"/cancers/undifferentiated-pleomorphic-sarcoma/"}],"technology":[{"id":"cytotoxic-chemotherapy","kind":"technology","name":"Cytotoxic chemotherapy","route":"/technologies/cytotoxic-chemotherapy/"}],"drug":[{"id":"ifosfamide","kind":"drug","name":"Ifosfamide","route":"/drugs/ifosfamide/"}],"company":[{"id":"italian-sarcoma-group","kind":"company","name":"Italian Sarcoma Group","route":"/companies/italian-sarcoma-group/"}],"term":[{"id":"fnclcc-grade","kind":"term","name":"FNCLCC grade (soft-tissue sarcoma)","route":"/terms/fnclcc-grade/"},{"id":"sarcoma-histotype-tailoring","kind":"term","name":"Histotype-tailored therapy","route":"/terms/sarcoma-histotype-tailoring/"}],"person":[{"id":"alessandro-gronchi","kind":"person","name":"Alessandro Gronchi","route":"/people/alessandro-gronchi/"}],"paper":[{"id":"paper-isg-sts-1001-gronchi-lancet-oncol-2017","kind":"paper","name":"ISG-STS 1001: histotype-tailored neoadjuvant chemotherapy versus standard chemotherapy in high-risk soft tissue sarcoma","route":"/key-papers/paper-isg-sts-1001-gronchi-lancet-oncol-2017/"}]}}