NCT06144736 PRIMETEST II - Clinical Stage II A/B Seminoma Treated With RA-RPLND
| NCT ID | NCT06144736 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | Heinrich-Heine University, Duesseldorf |
| Condition | Seminoma |
| Study Type | INTERVENTIONAL |
| Enrollment | 60 participants |
| Start Date | 2023-08-28 |
| Primary Completion | 2026-08-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 60 participants in total. It began in 2023-08-28 with a primary completion date of 2026-08-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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-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 Criteria
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)
Contact & Investigator
Yue Che
PRINCIPAL INVESTIGATOR
University Hospital of Düsseldorf
Frequently Asked Questions
Who can join the NCT06144736 clinical trial?
This trial is open to male participants only, aged 18 Years or older, up to 99 Years, studying Seminoma. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06144736 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT06144736 currently recruiting?
Yes, NCT06144736 is actively recruiting participants. Contact the research team at yue.che@med.uni-duesseldorf.de for enrollment information.
Where is the NCT06144736 trial being conducted?
This trial is being conducted at Düsseldorf, Germany.
Who is sponsoring the NCT06144736 clinical trial?
NCT06144736 is sponsored by Heinrich-Heine University, Duesseldorf. The principal investigator is Yue Che at University Hospital of Düsseldorf. The trial plans to enroll 60 participants.