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

NCT05345158 | Recruiting

• 1 other identifier: 21-5242
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (2)

• Relapse Free Survival (RFS)

  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.

  2 years after RPLND

• Relapse Free Survival (RFS)

  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.

  5 years after RPLND

Secondary Outcomes (24)

• Rate of relapse

  Study duration (5 years)

• Time to progression (TTP)

  Study duration (5 years)

• Relapse in vs. out of surgical field

  Study duration (5 years)

• Relapse tumour characteristics

  Study duration (5 years)

• Mode of relapse detection

  Study duration (5 years)

Study Arms (1)

Robotic Retroperitoneal Lymph Node Dissection

EXPERIMENTAL

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

Procedure: Robotic Retroperitoneal Lymph Node Dissection (RPLND)

Interventions

Robotic Retroperitoneal Lymph Node Dissection (RPLND) PROCEDURE

Robotic RPLND performed using the DaVinci robotic surgical system.

Robotic Retroperitoneal Lymph Node Dissection

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• University Health Network, Toronto: lead

Study Sites (1)

Princess Margaret Cancer Centre

Toronto, Ontario, M5G 2M9, Canada

RECRUITING

MeSH Terms

Conditions

Seminoma

Condition Hierarchy (Ancestors)

Germinoma; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms

Study Officials

• Robert Hamilton, MD

  The Princess Margaret Cancer Foundation

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Robert Hamilton, MD

CONTACT

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

Isabelle Tan, BSc

CONTACT

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 3, 2022
• First Posted: April 25, 2022
• Study Start: February 23, 2022
• Primary Completion (Estimated): November 1, 2030
• Study Completion (Estimated): November 1, 2030
• Last Updated: December 19, 2025

Record last verified: 2025-12

Locations

CA (1)