Status:
RECRUITING
PRIMETEST II - Clinical Stage II A/B Seminoma Treated With RA-RPLND
Lead Sponsor:
Heinrich-Heine University, Duesseldorf
Conditions:
Seminoma
Eligibility:
MALE
18-99 years
Phase:
PHASE2
Brief 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...
Detailed Description
Testicular cancer stands as the most prevalent cancer among young men, boasting a highly favorable prognosis characterized by almost unaltered long-term survival even in advanced stages. However, trad...
Eligibility Criteria
Inclusion
- 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
- 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)
Key Trial Info
Start Date :
August 28 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
August 31 2029
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT06144736
Start Date
August 28 2023
End Date
August 31 2029
Last Update
September 15 2025
Active Locations (1)
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1
University Hospital of Duesseldorf
Düsseldorf, Germany