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Clinical Trials in Germany / NCT06144736
Recruiting Phase 2

PRIMETEST II - Clinical Stage II A/B Seminoma Treated With RA-RPLND

NCT06144736 · tracked via the Priya Life Science Germany tracker
Phase
Phase 2
Started
2023-08-28
Last updated
2025-09-15

Condition(s) studied

Seminoma

Investigational drug(s) / intervention(s)

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)

Trial sites (1)

FacilityCityRegionStatus
University Hospital of Duesseldorf Düsseldorf Germany Recruiting

More Heinrich-Heine University, Duesseldorf trials in Germany

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Official registry record

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.

View NCT06144736 on ClinicalTrials.gov ↗ ← All trials in Germany