Clinical trial · Interventional
R-RPLND as First-line Treatment for Clinical Stage IIA/B Testicular Seminoma
Robotic Retroperitoneal Lymph Node Dissection (R-RPLND) as First-line Treatment for Clinical Stage IIA/B Testicular Seminoma
NCT05345158CI-TRIAL-00099415recruitingN/AClinicalTrials.gov clinicaltrialsProvenance
- 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)
This study will investigate the safety and efficacy of using robotic retroperitoneal lymph node dissection (R-RPLND), a minimally invasive surgical approach, as the first-line of treatment for stage IIA/B (or equivalent) seminoma patients. R-RPLND will be trialed as an alternative to chemotherapy, radiation therapy (for seminoma patients) and open RPLND in this study.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Lymphadenopathy Retroperitoneal | — | UNRESOLVED | — |
| Stage II Testicular Seminoma | Testicular Seminoma | CURATED_BROADER | 0.78 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Robotic Retroperitoneal Lymph Node Dissection (RPLND) | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Robotic Retroperitoneal Lymph Node Dissection
- description
- Robotic retroperitoneal lymph node dissection performed using the DaVinci robotic surgical system.
- interventionNames
- Procedure: Robotic Retroperitoneal Lymph Node Dissection (RPLND)
Primary outcomes (2)
- measure
- Relapse Free Survival (RFS)
- timeFrame
- 2 years after RPLND
- description
- RFS is defined as the length of time between date of R-RPLND and 1) relapse or 2) death from any cause with censoring of patients lost to follow-up.
- measure
- Relapse Free Survival (RFS)
- timeFrame
- 5 years after RPLND
- description
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Histologically confirmed seminomatous testicular germ cell tumour with negative margins on radical orchiectomy * Lymphadenopathy in the retroperitoneum: at least one lymph node ≤5cm in size (in the transverse plane) detected on contrast CT scan or MRI (CS IIA/B; or active surveillance relapse with CS IIA/B equivalent) * CT Chest negative for metastasis * Patients qualify for this trial under the following scenarios: (1) initial diagnosis of clinical or stage IIA/B disease or (2) recurrence after surveillance for clinical stage I disease * Patients with serum tumour marker elevation are eligible if the elevated marker does not exceed the following cut-offs within 10 days of RPLND: AFP (\< 2.5 x ULN) and β-hCG (\<5 IU/L) * Curative treatment with RPLND is intended * Under the care of a uro-oncologist at Princess Margaret Cancer Centre * Willing to comply with follow-up protocol * Capable of providing informed consent Exclusion Criteria: * Retroperitoneal lymphadenopathy \>5cm in the transverse plane (CS IIC) * Metastasis to distant lymph nodes or any organ (CS III) * History of chemotherapy or radiotherapy to the retroperitoneum * Patients with previous scrotal or retroperitoneal surgery for indication other than germ cell tumour * Patients in reduced general condition, with uncontrolled intercurrent illnesses, or with life-threatening disease * Patients with psychiatric illnesses that would limit compliance with study requirements * Unsuitable for robotic surgery (determined by treating physician)
References
Publications (0)
Data not yet available
No reference posted for this study.