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

University Health Network, Toronto25 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Conditions

Lymphadenopathy Retroperitoneal Stage II Testicular Seminoma

Interventions

Robotic Retroperitoneal Lymph Node Dissection (RPLND)PROCEDURE

Robotic RPLND performed using the DaVinci robotic surgical system.

Eligibility

Sex: MALEMin age: 18 Years

Medical Language ↔ Plain English

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)

Locations (1)

Princess Margaret Cancer Centre

Toronto, Ontario, Canada

RECRUITING

Outcomes

Primary Outcomes

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.

Time frame: 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.

Time frame: 5 years after RPLND

Secondary Outcomes

Rate of relapse

Defined as the proportion of participants experiencing relapse after primary R-RPLND. Relapse is defined as a new mass meeting size criteria (\>1cm) with or without elevation of serum tumour markers.