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

NCT ID: NCT05345158

Last Updated: 2025-12-19

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 25 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-02-23
• Study Completion Date: 2030-11-30

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.

Detailed Description

Typical treatment for testicular cancer that has spread to the retroperitoneum is chemotherapy, radiation therapy, or surgery. Chemotherapy and radiation therapy have numerous side effects and long-term complications and open retroperitoneum lymph node dissection (RPLND), the typical surgical approach for advanced testicular cancer, can be invasive and is fairly morbid. 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. The primary endpoint of this study is Relapse Free Survival (RFS) at 2 years and 5 years. Secondary endpoints of this study include characteristics of relapse, time to progression, percentage of patients that can avoid chemotherapy and radiation therapy after R-RPLND, perioperative, short-term and long-term complications, rate of retrograde ejaculation, time to return of ejaculation and return to work. Additionally, Quality of Life will be measured by a questionnaire administered at 4 months post-RPLND. Approximately 25 patients will be enrolled in this study and will be followed for at least 5 years.

The data will provide important insights into the safety and efficacy of performing R-RPLND for seminoma patients with stage IIA/B (or equivalent) disease. This information will be paramount to informing clinical practice and patterns of care for treating advanced seminoma and use of the robotic approach for RPLND.

Conditions

Lymphadenopathy Retroperitoneal; Stage II Testicular Seminoma

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Robotic Retroperitoneal Lymph Node Dissection

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

Group Type: EXPERIMENTAL

Robotic Retroperitoneal Lymph Node Dissection (RPLND)

Intervention Type: PROCEDURE

Robotic RPLND performed using the DaVinci robotic surgical system.

Interventions

Robotic Retroperitoneal Lymph Node Dissection (RPLND)

Robotic RPLND performed using the DaVinci robotic surgical system.

Intervention Type: PROCEDURE

Eligibility Criteria

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)

• Minimum Eligible Age: 18 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: No

Sponsors

University Health Network, Toronto

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Robert Hamilton, MD

Role: PRINCIPAL_INVESTIGATOR

The Princess Margaret Cancer Foundation

Locations

Princess Margaret Cancer Centre

Toronto, Ontario, Canada

Site Status: RECRUITING

Countries

Canada

Central Contacts

Robert Hamilton, MD

Role: CONTACT

Phone: 416-946-2909

Email: rob.hamilton@uhn.ca

Isabelle Tan, BSc

Role: CONTACT

Phone: 416-946-2282

Email: isabelle.tan@uhn.ca

Facility Contacts

Robert Hamilton, MD

Role: primary

Other Identifiers

21-5242

Identifier Type: -

Identifier Source: org_study_id