PRIMETEST
Phase 2 Single-arm Trial of Primary Retroperitoneal Lymph Node Dissection in Patients with Seminomatous Testicular Germ Cell Tumors with Clinical Stage IIA/B (PRIMETEST)
Phase 2N = 33NCT02797626
- Population
- Patients with seminoma and clinical stage IIA/B disease (13 stage IIA and 20 stage IIB): nine with primary stage IIA/B, 19 recurrences during active surveillance and five recurrences after adjuvant carboplatin
- Design
- Single-arm, single-centre prospective phase 2 trial, 2016 to 2021. Patients with seminoma, unilateral retroperitoneal lymph node metastases below 5 cm and human chorionic gonadotropin below 5 mU/ml; eligible were those with clinical stage IIA/B at initial diagnosis and recurrences under active surveillance or after adjuvant carboplatin for clinical stage I disease. Unilateral open or robot-assisted primary RPLND without adjuvant treatment. The trial was considered positive if fewer than 30% of patients had a recurrence.
- Primary endpoint
- PFS
- Arms
- Primary RPLND (experimental, n = 33): Unilateral open (14 patients) or robot-assisted (19 patients) primary retroperitoneal lymph node dissection without adjuvant treatment
- People
- Hiester A
Show the numbers
| Endpoint | Analysis | Primary RPLND | Control | Effect |
|---|---|---|---|---|
| Relapse rateAccrued patientsShare of patients with a recurrence. The primary endpoint was progression-free survival at 36 months; the trial was positive if fewer than 30% of patients had a recurrence. | primarymedian follow-up 32 monthsHiester 2023 | 30% (16–49%) | — | Ten recurrences among 33 patients; the primary endpoint was not met. Infield recurrences occurred in three of the ten. Three of 33 patients (9%) had pN0 disease. The authors state a progression-free survival of 70% after a median follow-up of 32 months and conclude that surgery alone cannot be recommended outside a clinical trial. Median follow-up interquartile range 23 to 46 months. |
| Endpoint | Analysis | Primary RPLND | Control | Effect |
|---|---|---|---|---|
| Relapse rateAccrued patientsShare of patients with a recurrence. The primary endpoint was progression-free survival at 36 months; the trial was positive if fewer than 30% of patients had a recurrence. | primarymedian follow-up 32 monthsHiester 2023 | 30% (16–49%) | — | Ten recurrences among 33 patients; the primary endpoint was not met. Infield recurrences occurred in three of the ten. Three of 33 patients (9%) had pN0 disease. The authors state a progression-free survival of 70% after a median follow-up of 32 months and conclude that surgery alone cannot be recommended outside a clinical trial. Median follow-up interquartile range 23 to 46 months. |