Recruiting

R-RPLND

Sponsor:

University Health Network, Toronto

Code:

NCT05345158

Conditions

Lymphadenopathy Retroperitoneal

Stage II Testicular Seminoma

Eligibility Criteria

Sex: Male

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Robotic Retroperitoneal Lymph Node Dissection (RPLND)

Study Details

Brief 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.

Conditions

Lymphadenopathy Retroperitoneal

Stage II Testicular Seminoma

Study ID

NCT05345158

Start date

Feb 23, 2022

Status verified date

Dec, 2025

Completion date

Nov, 2030

Anticipated

Primary completion date

Nov, 2030

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Male

Age: 18+

Healthy Volunteers: Not accepted

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)

Study Design

Enrollment

25 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Robotic Retroperitoneal Lymph Node Dissection

Robotic retroperitoneal lymph node dissection performed using the DaVinci robotic surgical system.

Interventions

Robotic Retroperitoneal Lymph Node Dissection (RPLND)

Robotic RPLND performed using the DaVinci robotic surgical system.

Primary outcome measure

  • Relapse Free Survival (RFS) [ Time Frame: 2 years after RPLND ]
  • Relapse Free Survival (RFS) [ Time Frame: 5 years after RPLND ]

Central Contacts and Locations

Central contacts

Robert Hamilton, MD

416-946-2909rob.hamilton@uhn.ca

Isabelle Tan, BSc

416-946-2282isabelle.tan@uhn.ca

Locations

Princess Margaret Cancer Centre

Recruiting

Toronto, Ontario, Canada, M5G 2M9

Contacts

Robert Hamilton, MD

416-946-2909

More Information

Sponsor

University Health Network, Toronto

Last update posted

Dec 19, 2025

Last verified

Dec, 2025

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University Health Network, Toronto on 2025-12-19.