Blood and Lymph Conditions

All Conditions

Neoplasms

Rare Diseases

Lymphadenopathy

Seminoma

Germinoma

Neoplasms, Germ Cell and Embryonal

Neoplasms by Histologic Type

Lymphatic Diseases

Testicular Seminoma

Central Nervous System Germinoma

Laboratory Biomarker Analysis

Retroperitoneal Lymph Node Dissection

Siamak Daneshmand

This phase II trial studies how well retroperitoneal lymph node dissection (RPLND) works in treating patients with stage I-IIa testicular seminoma. The retroperitoneum is the space in the body behind the intestines that is typically the first place that seminoma spreads. RPLND is a surgery that removes lymph nodes in this area to treat testicular seminoma and may experience fewer long-term toxicities, such as a second cancer, cardiovascular disease, metabolic syndrome (pre-diabetes), or lung disease.

PRIMARY OBJECTIVES:

I. Assess the recurrence free survival (RFS) at 2 years after RPLND when RPLND is used as a first line treatment for patients with testicular seminoma and low volume (=\< 2cm) retroperitoneal disease.

SECONDARY OBJECTIVES:

I. Estimate the percent of patients, after treatment with RPLND, who can avoid external beam radiotherapy (XRT) or systemic chemotherapy (CTX) for seminoma.

II. Assess the complications associated with primary RPLND for seminoma.

OUTLINE:

Patients undergo RPLND.

After completion of study treatment, patients are followed up at 1 month, every 4 months for 1 year, every 6 months for 2 years, and then annually thereafter.

Retroperitoneal Lymph Node Dissection in Treating Patients With Testicular Seminoma

Surgery in Early Metastatic Seminoma (SEMS): Phase II Trial of Retroperitoneal Lymph Node Dissection as First-Line Treatment for Testicular Seminoma With Isolated Retroperitoneal Disease (1-3cm)

Associated 95% confidence intervals will be constructed. Actuarial RFS will be calculated by the Kaplan Meier method. The recurrence location (pelvic, retroperitoneal, distant) will be calculated as a percentage of total recurrences to describe the clinical pattern of disease after relapse.

The rate of short and long term complications will be calculated.

Associated 95% confidence intervals will be constructed. Actuarial RFS will be calculated by the Kaplan Meier method.

National Cancer Institute (NCI)

University of Southern California

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
Retroperitoneal Lymph Node Dissection in Treating Patients With Testicular Seminoma	NCT02537548	Lymphadenopathy Stage I Testicu... Stage II Testic...	Laboratory Biom... Retroperitoneal...	16 Years -	University of Southern California
Retroperitoneal Lymph Node Dissection in Treating Patients With Testicular Seminoma	NCT02537548	Lymphadenopathy Stage I Testicu... Stage II Testic...	Laboratory Biom... Retroperitoneal...	16 Years -	University of Southern California
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

Spots Global Cancer Trial Database for stage ii testicular seminoma