Clinical trial · Interventional
PRIMETEST II - Clinical Stage II A/B Seminoma Treated With RA-RPLND
PRIMETEST II - Phase II Trial to Prospectively Test New Predictors for Recurrence in Patients With Clinical Stage II A/B Seminoma Treated With RA-RPLND
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Seminoma | Seminoma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Adjuvant therapy with one cycle of cisplatin, etoposide and bleomycin | Drug | — | UNRESOLVED |
| Robot-assisted retroperitoneal lymph node dissection | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Low risk
- description
- Criteria for "low risk": * Absence of "high risk" criteria * Previous carboplatin therapy post orchiectomy * Exclusion of malignancy in the RPLND histology
- interventionNames
- Procedure: Robot-assisted retroperitoneal lymph node dissection
- type
- EXPERIMENTAL
- label
- High risk
- description
- Criteria for "high risk": * Clinical stage II at initial diagnosis * Primary tumor \> 4 cm * Infiltration of the "rete testis" in the primary tumor
- interventionNames
- Procedure: Robot-assisted retroperitoneal lymph node dissection
- Drug: Adjuvant therapy with one cycle of cisplatin, etoposide and bleomycin
Primary outcomes (1)
- measure
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 18 Years
- Maximum age
- 99 Years
Show eligibility criteria text
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)
References
Publications (0)
Data not yet available