# GETUG 13

Source: https://onco.cc/trials/getug-13/  
OnCo record `getug-13` (Trial). Data CC BY-NC 4.0, attribute "Data from OnCo (onco.cc)"; commercial use needs a licence.

## TL;DR

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.

Three-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.

## Fields

- Kind: Trial
- Status: positive
- Last checked: 2026-09-22
- Also known as: GETUG-13; GETUG13
- Tags: soc-trials
- Registry id: 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
- Enrolled: 263
- 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.
- Outcomes: Progression-free survival at 3 years, unfavourable marker decline: Dose-dense chemotherapy (T-BEP-oxaliplatin then cisplatin, ifosfamide, bleomycin) 59% vs Standard BEP 48%, HR 0.66; Progression-free survival at 3 years, favourable marker decline (continued BEP, not randomised): BEP after favourable marker decline 70%; Salvage high-dose chemotherapy with stem cell transplant required: Dose-dense chemotherapy 6% vs Standard BEP 16%; Grade 3 to 4 neurotoxicity: Dose-dense chemotherapy 7% vs Standard BEP 1%

## Sources

- ClinicalTrials.gov NCT00104676: https://clinicaltrials.gov/study/NCT00104676

## Connected records

- cancers: [Non-seminomatous germ cell tumour](https://onco.cc/cancers/non-seminoma/), [Testicular germ cell tumours](https://onco.cc/cancers/testicular/)
- technologies: [Cytotoxic chemotherapy](https://onco.cc/technologies/cytotoxic-chemotherapy/)
- drugs: [Bleomycin](https://onco.cc/drugs/bleomycin/), [Cisplatin](https://onco.cc/drugs/cisplatin/), [Etoposide](https://onco.cc/drugs/etoposide/), [Ifosfamide](https://onco.cc/drugs/ifosfamide/), [Oxaliplatin](https://onco.cc/drugs/oxaliplatin/), [Paclitaxel / nab-paclitaxel](https://onco.cc/drugs/paclitaxel/)
- institutions: [MD Anderson Cancer Center](https://onco.cc/institutions/md-anderson/), [UNICANCER](https://onco.cc/institutions/unicancer/)
- key papers: [GETUG 13: personalised chemotherapy based on tumour marker decline in poor-prognosis germ cell tumours](https://onco.cc/key-papers/paper-getug-13-marker-guided-dose-dense-chemotherapy-fizazi-lancet-oncol-2014/)

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