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

University Health Network, Toronto

Status

Enrolling

Conditions

Lymphadenopathy Retroperitoneal

Stage II Testicular Seminoma

Treatments

Procedure: Robotic Retroperitoneal Lymph Node Dissection (RPLND)

Study type

Interventional

Funder types

Other

Identifiers

NCT05345158

21-5242

Details and patient eligibility

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.

Full 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.

Enrollment

25 estimated patients

Sex

Male

Ages

18+ years old

Volunteers

No Healthy Volunteers

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)