Trial reportEuropean urology2020
The 111 Study: A Single-arm, Phase 3 Trial Evaluating One Cycle of Bleomycin, Etoposide, and Cisplatin as Adjuvant Chemotherapy in High-risk, Stage 1 Nonseminomatous or Combined Germ Cell Tumours of the Testis.
Trial report in European urology, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT01726374 (A Single Group Trial Evaluating One Cycle of Adjuvant BEP Chemotherapy in High Risk, Stage 1 Non-seminomatous Germ Cell Tumours of the Testis), which is not on this map. Cited by 19 papers, 2 of them syntheses that pooled it.
What it found
Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.
The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
A Single Group Trial Evaluating One Cycle of Adjuvant BEP Chemotherapy in High Risk, Stage 1 Non-seminomatous Germ Cell Tumours of the Testis (NSGCTT)
Who cites it
19 citing papers in PubMed, 2 syntheses or guidelines pooled it, 55 citations in OpenAlex.
- SEOM-GG clinical guidelines for the management of germ-cell testicular cancer (2023).Clinical & translational oncology : official publication of the Federation of Spanish Oncology Societies and of the National Cancer Institute of Mexico · 2024Guideline
- A Systematic Review Investigating the Difference between 1 Cycle versus 2 Cycles of Adjuvant Chemotherapy in Stage I Testicular Germ Cell Cancers.Medicina (Kaunas, Lithuania) · 2023Pooled it
- A Retrospective Analysis of Testicular Cancer (2007-2025): A Single Institutional Experience.Research and reports in urology · 2026Article
- Testicular Cancer: Diagnosis, Treatment, and Biomarker Advances.Research and reports in urology · 2026Review
- Review
- New insights on testicular cancer prevalence with novel diagnostic biomarkers and therapeutic approaches.Cancer reports (Hoboken, N.J.) · 2024Review
- Role of Epigenetics for the Efficacy of Cisplatin.International journal of molecular sciences · 2024Review
- Active surveillance: minimising treatment while maximising outcomes in testis cancer.Translational andrology and urology · 2023Article
- Epigenetic Factors and ncRNAs in Testicular Cancer.International journal of molecular sciences · 2023Review
- Survival of Testicular Pure Teratoma vs. Mixed Germ Cell Tumor Patients in Primary Tumor Specimens across All Stages.Cancers · 2023Article
- Clinical features and prognostic factors in patients diagnosed with lymphovascular invasion of testicular germ-cell tumors: Analysis based on the SEER database.Frontiers in oncology · 2023Article
- Biomarkers of disease recurrence in stage I testicular germ cell tumours.Nature reviews. Urology · 2022Review
- Canadian Urological Association consensus guideline: Management of testicular germ cell cancer.Canadian Urological Association journal = Journal de l'Association des urologues du Canada · 2022Article
- Single-course bleomycin, etoposide, and cisplatin (1xBEP) as adjuvant treatment in testicular nonseminoma clinical stage 1: outcome, safety, and risk factors for relapse in a population-based study.Therapeutic advances in medical oncology · 2022Article
- Editorial by Bendu K. Konneh, John T. Lafin and Aditya Bagrodia on pp. 341-342 of this issue: MicroRNA-371a-3p as a blood-based biomarker in testis cancer.Asian journal of urology · 2021Article
- [non-metastasised clincial stage I testicular germ cell tumours : Patient information, suitability and limitations of surveillance].Der Urologe. Ausg. A · 2021Review
- LAPTM5 Plays a Key Role in the Diagnosis and Prognosis of Testicular Germ Cell Tumors.International journal of genomics · 2021Article
- Controversies in the management of clinical stage 1 testis cancer.Canadian Urological Association journal = Journal de l'Association des urologues du Canada · 2020Article
- Approach to chemotherapy for high-risk, stage 1, non-seminomatous, germ cell testicular tumors.Indian journal of urology : IJU : journal of the Urological Society of IndiaArticle
Corrections and comments
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Authors and funding
16 authors at 8 institutions in 1 country.
Funding
Abstract
backgroundStandard management in the UK for high-risk stage 1 nonseminoma germ cell tumours of the testis (NSGCTT) is two cycles of adjuvant bleomycin, etoposide (360 mg/m
objectiveTo test whether one cycle of BE DESIGN, SETTING, AND
participantsA total of 246 patients with vascular invasion-positive stage 1 NSGCTT or combined seminoma + NSGCTT were centrally registered in a single-arm prospective study.
interventionOne cycle comprising bleomycin 30000 IU on days 1, 8, and 15, etoposide 165 mg/m OUTCOME MEASUREMENTS AND STATISTICAL ANALYSIS: The primary endpoint was 2-yr malignant recurrence (MR); the aim was to exclude a rate of ≥5%. Participants had regular imaging and tumour marker (TM) assessment for 5 yr. RESULTS AND LIMITATIONS: The median follow-up was 49 mo (interquartile range 37-60). Ten patients with rising TMs at baseline were excluded. Four patients had MR at 6, 7, 13, and 27 mo; all received second-line chemotherapy and surgery and three remained recurrence-free at 5 yr. The 2-yr MR rate was 1.3% (95% confidence interval 0.3-3.7%). Three patients developed nonmalignant recurrences with localised teratoma differentiated, rendered disease-free after surgery. Grade 3-4 febrile neutropenia occurred in 6.8% of participants.
conclusionsBE PATIENT SUMMARY: Removing the testicle fails to cure many patients with high-risk primary testicular cancer since undetectable cancers are often present elsewhere. A standard additional treatment in Europe is two cycles of chemotherapy to eradicate these. This trial shows one cycle has few adverse effects and comparable outcomes to those seen with two cycles.
Indexed as
Identifiers
What OpenQuestion holds
Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.