Clinical trial · Interventional
Trial to Evaluate Progression Free Survival With Primary Retroperitoneal Lymph-node Dissection (pRPLND) Only in Patients With Seminomatous Testicular Germ Cell Tumors With Clinical Stage IIA/B (PRIMETEST)
Phase II Single-arm Trial to Evaluate Progression Free Survival With Primary Retroperitoneal Lymph-node Dissection (pRPLND) Only in Patients With Seminomatous Testicular Germ Cell Tumors With Clinical Stage IIA/B (PRIMETEST)
- 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)
Primary objective: to evaluate progression-free survival in patients with clinical stage II A/B seminomatous germ cell tumor undergoing primary retroperitoneal lymph node dissection (RPLND) without adjuvant treatment Secondary objectives: * overall survival * perioperative complications (Clavien-Dindo score) * quality of life (EORTC QLQ C30, EORTC QLQ TC26) * long term sequelae * rate of retrograde ejaculation
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 |
|---|---|---|---|
| Stage II A/B Seminomatous Germ Cell Tumors | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Primary retroperitoneal lymph-node dissection (pRPLND) | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- OTHER
- label
- Primary RPNLD
- interventionNames
- Procedure: Primary retroperitoneal lymph-node dissection (pRPLND)
Primary outcomes (1)
- measure
- progression-free survival
- timeFrame
- 3 years
Eligibility
Eligibility (as posted)
- Sex
- Male
Show eligibility criteria text
Inclusion Criteria: * histologically confirmed seminomatous testicular germ cell tumor * inguinal, paraaortic or retroperitoneal lymph nodes classified as local or regional unilateral lymph node metastasis by contrast CT or MRI * maximum dimensions of lymph node metastasis: single mass of max. 5.0 cm in transverse CT diameter multiple metastases in a unilateral field with single max. diameter of 5.0 cm (UICC IIB) patients with serum tumour marker elevation at the time of CT staging are eligible if the elevated human chorionic gonadotropin (hCG) directly before RPLND does not exceed 5 IU/L * patients qualify for this trial with following scenarios 1. initial diagnosis of UICC clinical stage IIA/IIB disease 2. recurrence after surveillance for clinical stage I 3. recurrence after adjuvant treatment of clinical stage I seminoma with 1 x carboplatin AUC7 * curative treatment is intended * patient´s age above 18 years * able to communicate well with the investigator, to understand and comply with the requirements of the study, to understand and sign the written informed consent. Exclusion Criteria: * non-seminomatous germ cell tumors * germ cell tumor-related AFP elevation suspicious of non-seminoma * metastatic lymph node mass with greatest dimension \>5 cm (CS IIC) * other metastasis (CS III) * patients with prior scrotal or retroperitoneal surgery due to other diseases than germ cell cancer * patient underwent chemotherapy other than adjuvant Carboplatin monotherapy * patient underwent radiotherapy of the retroperitoneum * patient in reduced general condition or with live threatening disease * patient has a psychiatric disease * patient does not have sufficient knowledge of German language
References
Publications (0)
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