Actively Recruiting

Phase Not Applicable
Age: 18Years +
MALE
NCT05345158

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

Led by University Health Network, Toronto · Updated on 2025-12-19

25

Participants Needed

1

Research Sites

453 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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

Official Title

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

Who Can Participate

Age: 18Years +
MALE

Eligibility Criteria

Eligible

You may qualify if you...

  • 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 detected on contrast CT scan or MRI (CS IIA/B or active surveillance relapse with CS IIA/B equivalent)
  • CT Chest negative for metastasis
  • Initial diagnosis of clinical or stage IIA/B disease or recurrence after surveillance for clinical stage I disease
  • Serum tumour marker levels within 10 days of RPLND: AFP below 2.5 times upper limit of normal and b2-hCG below 5 IU/L
  • Curative treatment with RPLND is intended
  • Under care of a uro-oncologist at Princess Margaret Cancer Centre
  • Willing to comply with follow-up protocol
  • Capable of providing informed consent
Not Eligible

You will not qualify if you...

  • Retroperitoneal lymphadenopathy larger than 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
  • Previous scrotal or retroperitoneal surgery for reasons other than germ cell tumour
  • Reduced general condition, uncontrolled illnesses, or life-threatening disease
  • Psychiatric illnesses limiting compliance with study requirements
  • Unsuitable for robotic surgery as determined by treating physician

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

Princess Margaret Cancer Centre

Toronto, Ontario, Canada, M5G 2M9

Actively Recruiting

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Research Team

R

Robert Hamilton, MD

CONTACT

I

Isabelle Tan, BSc

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

TREATMENT

Number of Arms

1

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