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Clinical Trials in Canada / NCT05345158
Recruiting Not applicable

R-RPLND as First-line Treatment for Clinical Stage IIA/B Testicular Seminoma

NCT05345158 · tracked via the Priya Life Science Canada tracker
Phase
Not applicable
Started
2022-02-23
Last updated
2025-12-19

Condition(s) studied

Lymphadenopathy RetroperitonealStage II Testicular Seminoma

Investigational drug(s) / intervention(s)

Robotic Retroperitoneal Lymph Node Dissection (RPLND)

Robotic Retroperitoneal Lymph Node Dissection (RPLND): Robotic RPLND performed using the DaVinci robotic surgical system.

Study summary

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.

Eligibility

Sex
MALE
Min age
18 Years
Max age
—
Healthy volunteers
No
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)

Primary outcome measure(s)

Trial sites (1)

FacilityCityRegionStatus
Princess Margaret Cancer Centre Toronto Ontario Recruiting

More University Health Network, Toronto trials in Canada

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT05345158 on ClinicalTrials.gov ↗ ← All trials in Canada