{"entity":{"id":"getug-13","kind":"trial","name":"GETUG 13","aka":["GETUG-13","GETUG13"],"tldr":"GETUG 13 showed that men with the worst-risk testicular cancers whose tumour markers fall too slowly after the first cycle of chemotherapy do better if treatment is intensified: 59 percent were free of progression at three years against 48 percent with standard BEP, and fewer needed high-dose salvage chemotherapy.","summary":"GETUG 13 was a phase 3 trial of the French GETUG group with MD Anderson and Slovak centres in 263 patients with poor-prognosis (IGCCCG) non-seminomatous germ cell tumours. After one cycle of bleomycin, etoposide and cisplatin, the 203 patients with an unfavourable decline in alpha-fetoprotein and hCG were randomised to three further BEP cycles or a dose-dense regimen (paclitaxel-BEP-oxaliplatin followed by cisplatin, ifosfamide and bleomycin with growth factor support); the 51 with a favourable decline continued BEP. The primary endpoint was progression-free survival.\n\nThree-year progression-free survival was 59 percent with dose-dense chemotherapy against 48 percent with BEP (hazard ratio 0.66, p 0.05), with more grade 3 to 4 neurotoxicity and haematological toxicity but no difference in toxic deaths, and fewer patients needed salvage high-dose chemotherapy (6 against 16 percent). Marker-guided intensification became the approach for poor-prognosis disease, which is how the corpus's testicular cancer page cites the trial.","status":"positive","asOf":"2026-09-22","links":[{"label":"ClinicalTrials.gov NCT00104676","url":"https://clinicaltrials.gov/study/NCT00104676"}],"tags":["soc-trials"],"related":[],"cancers":["non-seminoma","testicular"],"sections":[],"technologies":["cytotoxic-chemotherapy"],"targets":[],"drugs":["bleomycin","etoposide","cisplatin","paclitaxel","oxaliplatin","ifosfamide"],"companies":[],"institutions":["unicancer","md-anderson"],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":["paper-getug-13-marker-guided-dose-dense-chemotherapy-fizazi-lancet-oncol-2014"],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT00104676","phase":"3","setting":"Poor-prognosis disseminated non-seminomatous germ cell tumours in France, the United States and Slovakia: after one cycle of BEP, patients with an unfavourable tumour marker decline were randomised to continue BEP or switch to dose-dense chemotherapy (paclitaxel-BEP-oxaliplatin then cisplatin, ifosfamide and bleomycin), with progression-free survival as the primary endpoint","sponsor":"UNICANCER","result":"Three-year progression-free survival 59 percent with marker-guided dose-dense chemotherapy against 48 percent with BEP (hazard ratio 0.66, p 0.05); salvage high-dose chemotherapy needed in 6 against 16 percent.","yearReported":2014,"enrolled":263,"enrolledBasis":"registry","outcomes":[{"endpoint":"Progression-free survival at 3 years, unfavourable marker decline","primary":true,"unit":"%","arms":[{"name":"Dose-dense chemotherapy (T-BEP-oxaliplatin then cisplatin, ifosfamide, bleomycin)","n":105,"value":59,"note":"95% CI 49 to 68"},{"name":"Standard BEP","n":98,"value":48,"note":"95% CI 38 to 59"}],"hr":0.66,"ci":[0.44,1],"p":"0.05","source":"https://doi.org/10.1016/S1470-2045(14)70490-5"},{"endpoint":"Progression-free survival at 3 years, favourable marker decline (continued BEP, not randomised)","unit":"%","arms":[{"name":"BEP after favourable marker decline","n":51,"value":70,"note":"95% CI 57 to 81"}],"source":"https://doi.org/10.1016/S1470-2045(14)70490-5"},{"endpoint":"Salvage high-dose chemotherapy with stem cell transplant required","unit":"%","arms":[{"name":"Dose-dense chemotherapy","n":105,"value":6},{"name":"Standard BEP","n":98,"value":16}],"source":"https://doi.org/10.1016/S1470-2045(14)70490-5"},{"endpoint":"Grade 3 to 4 neurotoxicity","unit":"%","arms":[{"name":"Dose-dense chemotherapy","n":105,"value":7},{"name":"Standard BEP","n":98,"value":1}],"source":"https://doi.org/10.1016/S1470-2045(14)70490-5"}]},"route":"/trials/getug-13/","neighbours":{"cancer":[{"id":"non-seminoma","kind":"cancer","name":"Non-seminomatous germ cell tumour","route":"/cancers/non-seminoma/"},{"id":"testicular","kind":"cancer","name":"Testicular germ cell tumours","route":"/cancers/testicular/"}],"technology":[{"id":"cytotoxic-chemotherapy","kind":"technology","name":"Cytotoxic chemotherapy","route":"/technologies/cytotoxic-chemotherapy/"}],"drug":[{"id":"bleomycin","kind":"drug","name":"Bleomycin","route":"/drugs/bleomycin/"},{"id":"cisplatin","kind":"drug","name":"Cisplatin","route":"/drugs/cisplatin/"},{"id":"etoposide","kind":"drug","name":"Etoposide","route":"/drugs/etoposide/"},{"id":"ifosfamide","kind":"drug","name":"Ifosfamide","route":"/drugs/ifosfamide/"},{"id":"oxaliplatin","kind":"drug","name":"Oxaliplatin","route":"/drugs/oxaliplatin/"},{"id":"paclitaxel","kind":"drug","name":"Paclitaxel / nab-paclitaxel","route":"/drugs/paclitaxel/"}],"institution":[{"id":"md-anderson","kind":"institution","name":"MD Anderson Cancer Center","route":"/institutions/md-anderson/"},{"id":"unicancer","kind":"institution","name":"UNICANCER","route":"/institutions/unicancer/"}],"paper":[{"id":"paper-getug-13-marker-guided-dose-dense-chemotherapy-fizazi-lancet-oncol-2014","kind":"paper","name":"GETUG 13: personalised chemotherapy based on tumour marker decline in poor-prognosis germ cell tumours","route":"/key-papers/paper-getug-13-marker-guided-dose-dense-chemotherapy-fizazi-lancet-oncol-2014/"}]}}