Actively Recruiting
PRIMETEST II - Clinical Stage II A/B Seminoma Treated With RA-RPLND
Led by Heinrich-Heine University, Duesseldorf · Updated on 2025-09-15
60
Participants Needed
1
Research Sites
313 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
PRIMETEST II - Clinical Stage II A/B Seminoma Treated With RA-RPLND
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Histologically confirmed pure seminomatous testicular germ cell tumor
- Presence of iliac or retroperitoneal lymph node metastasis detected by contrast-enhanced CT or MRI, classified as local or unilaterally regional
- Maximum size of lymph node metastasis up to 5 cm in transverse CT diameter (UICC IIB)
- HCG elevation after orchiectomy allowed if preoperative HCG does not exceed 5 IU/L
- Initial diagnosis in UICC stage IIA/IIB or recurrence in clinical stage I under active surveillance or after adjuvant carboplatin mono therapy
You will not qualify if you...
- Lymph node metastases larger than 5 cm in transverse diameter (UICC IIC)
- Metastases beyond lymph nodes (UICC III)
- Previous chemotherapy other than carboplatin mono
- Previous retroperitoneal radiotherapy
- Reduced general condition or life-threatening illness
- Psychiatric illness
- Non-seminomatous germ cell tumor components in RPLND histology
- Incomplete resection due to previous surgeries
- Contraindications to cisplatin, etoposide, or bleomycin in high-risk group (e.g., severe liver, kidney, or lung insufficiency; hypersensitivity; bone marrow depression; hearing impairments)
AI-Screening
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Trial Site Locations
Total: 1 location
1
University Hospital of Duesseldorf
Düsseldorf, Germany
Actively Recruiting
Research Team
Y
Yue Che
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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