C62
Conditions
Interventions
Group 1: "Low-risk" patients: a robot-assisted, if possible ipsilateral nerve-sparing, retroperitoneal lymphadenectomy and metastasis resection in the unilateral dissection field ("template") without
Sponsors
Universitätsklinikum Düsseldorf
Eligibility
Sex/Gender
Male
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: - Histologically verified seminomatous testicular germ cell tumour - and an iliac or retroperitoneal lymph node metastasis detected on contrast CT or MRI, which is classified as local or unilateral regionally. - maximum extension of the lymph node metastasis (LK-M) singular or multiple with a maximum size of 5 cm in transverse CT diameter (UICC IIB)
Exclusion criteria
Exclusion criteria: - LK-M with a transverse diameter >5 cm in the C (UICC IIC) - Metastases other than LK-M (UICC III) - The patient has received chemotherapy other than described above - The patient has been treated with radiotherapy of the retroperitoneum - The patient is in a reduced general condition or has a life-threatening illness - The patient has a psychiatric illness - Evidence of non-seminomatous germ cell tumour on RPLND histology - Complete resection cannot be safely guaranteed due to previous surgery - In the "high risk" group: contraindications to cisplatin, etoposide or bleomycin (severe hepatic insufficiency, severe renal insufficiency, severe pulmonary insufficiency, hypersensitivity, severe bone marrow depression, marked hearing impairment).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Progression-free survival at 3 years | — |
Secondary
| Measure | Time frame |
|---|---|
| - Time to progression (TTP) from surgery date - Cancer-specific survival (CSS) and overall survival (OS) - Intraoperative complications according to "Intraoperative Adverse Incident Classification (EAUiaiC) by the European Association of Urology ad hoc Complications Guidelines Panel". - Perioperative complications and long-term complications according to Clavien Dindo - Health-related quality of life and mental health - Rate of patients with postoperative retrograde ejaculation - Investigation of the novel biomarker microRNA-371 - Molecular analysis (immunohistochemistry, DNA/RNA sequencing) of histological samples to identify possible prognostic factors at the cellular level | — |
Countries
Germany
Contacts
Public ContactYue Che
Universitätsklinikum Düsseldorf
Outcome results
None listed