Blood and Lymph Conditions

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Neoplasms

Rare Diseases

Lymphadenopathy

Seminoma

Germinoma

Neoplasms, Germ Cell and Embryonal

Neoplasms by Histologic Type

Lymphatic Diseases

Testicular Seminoma

Central Nervous System Germinoma

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

Robotic RPLND performed using the DaVinci robotic surgical system.

Robotic Retroperitoneal Lymph Node Dissection (RPLND)

Robert Hamilton, MD

Kopika Kuhathaas, BSc

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.

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

Robotic Retroperitoneal Lymph Node Dissection (R-RPLND) as First-line Treatment for Clinical Stage IIA/B Testicular Seminoma

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.

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.

TTP is defined as the time elapsed between date of R-RPLND and disease progression.

Relapse is classified as in vs. out of R-RPLND surgical field.

Mode of relapse detection (e.g., CT, serum tumour markers, physical exam, etc.).

International Germ Cell Cancer Collaborative Group (IGCCCG) risk classification

Defined as the length of time from date of R-RPLND to the date of death from disease.

Defined as the length of time from the date of R-RPLND until death due to any cause.

Percentage of patients, after treatment with R-RPLND, that are able to avoid chemotherapy and radiotherapy.

Perioperative, short-term (≤30 days) and long-term (\>30 days) complications. Scored using the Clavien Dindo classification system and assessed as attributable to R-RPLND by physician.

Measured using the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire for cancer patients (EORTC QLQ-C30).

Measured using the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire for testicular cancer patients (EORTC QLQ-TC26).

Self-reported by the patient and queried at each study visit until return to work.

Self-reported by the patient and queried at each study visit until ejaculation returns.

Defined as the duration of time between R-RPLND and study visit when patient self-reports return of ejaculatory function.

Operative time (minutes) for surgical metrics.

Estimated blood loss (mL) for surgical metrics.

Transfusion rate (mL) for surgical metrics.

Type of hemostatic agents used during surgery for surgical metrics.

Number of hemostatic agents used during surgery for surgical metrics.

Conversion rate to open surgery for surgical metrics.

Length of stay (in days) from the date of admission to date of discharge.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
R-RPLND as First-line Treatment for Clinical Stage IIA/B Testicular Seminoma	NCT05345158	Lymphadenopathy... Stage II Testic...	Robotic Retrope...	18 Years -	University Health Network, Toronto
R-RPLND as First-line Treatment for Clinical Stage IIA/B Testicular Seminoma	NCT05345158	Lymphadenopathy... Stage II Testic...	Robotic Retrope...	18 Years -	University Health Network, Toronto

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