Robot-assisted retroperitoneal lymph node dissectionAdjuvant therapy with one cycle of cisplatin, etoposide and bleomycin
Robot-assisted retroperitoneal lymph node dissection: Robot-assisted, if possibe ipsilateral nerve-sparing, retroperitoneal lymph node dissection and metastasis resection in a unilateral dissection field ("template")
Adjuvant therapy with one cycle of cisplatin, etoposide and bleomycin: The patient is given the option for an adjuvant therapy with one cycle of cisplatin, etoposide and bleomycin two to four weeks after RA-RPLND
Study summary
PRIMETEST II is an interventional study involving low-volume metastatic seminoma. It explores a novel approach using robot-assisted primary retroperitoneal lymph node dissection, aiming to reduce long-term side effects and improve quality of life. By identifying factors predicting cancer recurrence, the study hopes to tailor treatments for better outcomes. The approach could potentially spare patients from chemotherapy induced long-term side effects while maintaining excellent survival rates, presenting a promising shift in testicular cancer care for this specific patient group.
Eligibility
Sex
MALE
Min age
18 Years
Max age
99 Years
Healthy volunteers
No
Inclusion Criteria:
* Histologically confirmed pure seminomatous testicular germ cell tumor
* Presence of iliac or retroperitoneal lymph node metastasis detected in contrast-enhanced CT or MRI, classified as local or unilaterally regional
* Maximum extent of lymph node metastasis (LN-M) singular or multiple, with a maximum size of 5 cm in transverse CT diameter (UICC IIB)
* Patients with an elevation in HCG after orchiectomy at the time of staging examination can be included if the directly preoperatively determined HCG does not exceed 5 IU/L.
Patients can be included in the following scenarios:
* Initial diagnosis of a tumor in UICC stage IIA/IIB
* Recurrence of a tumor in clinical stage (CS) I under active surveillance
* Recurrence of a CS I tumor after adjuvant therapy with carboplatin mono
Exclusion Criteria:
* LN-M with a transverse diameter \>5 cm in CT (UICC IIC)
* Other metastases than LN-M (UICC III)
* The patient received a different chemotherapy than described above
* The patient underwent retroperitoneal radiotherapy
* 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 tumor components in the RPLND histology
* Complete resection cannot be ensured due to previous surgeries
* In the "high risk" group: Contraindications to cisplatin, etoposide, or bleomycin (severe liver insufficiency, severe kidney insufficiency, severe lung insufficiency, hypersensitivity, severe bone marrow depression, profound hearing impairments)
Primary outcome measure(s)
Progression-free survival — 3 years
Trial sites (1)
Facility
City
Region
Status
University Hospital of Duesseldorf
Düsseldorf
Germany
Recruiting
More Heinrich-Heine University, Duesseldorf trials in Germany
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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