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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Lymphadenopathy Retroperitoneal, Stage II Testicular Seminoma

Intervention / Treatment
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* Procedure: Robotic Retroperitoneal Lymph Node Dissection (RPLND)


Participation Criteria
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Eligibility Criteria
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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)

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Robotic Retroperitoneal Lymph Node Dissection<br>Robotic retroperitoneal lymph node dissection performed using the DaVinci robotic surgical system. | Procedure: Robotic Retroperitoneal Lymph Node Dissection (RPLND)<br>* Robotic RPLND performed using the DaVinci robotic surgical system.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 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. | 5 years after RPLND | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | Study duration (5 years) | 
| Time to progression (TTP) | TTP is defined as the time elapsed between date of R-RPLND and disease progression. | Study duration (5 years) | 
| Relapse in vs. out of surgical field | Relapse is classified as in vs. out of R-RPLND surgical field. | Study duration (5 years) | 
| Relapse tumour characteristics | Tumour size (in cm) and location | Study duration (5 years) | 
| Mode of relapse detection | Mode of relapse detection (e.g., CT, serum tumour markers, physical exam, etc.). | Study duration (5 years) | 
| Treatment burden | Number and type of treatment modalities | Study duration (5 years) | 
| IGCCCG risk classification | International Germ Cell Cancer Collaborative Group (IGCCCG) risk classification | Study duration (5 years) | 
| Cancer-specific survival (CSS) | Defined as the length of time from date of R-RPLND to the date of death from disease. | Study duration (5 years) | 
| Overall survival (OS) | Defined as the length of time from the date of R-RPLND until death due to any cause. | Study duration (5 years) | 
| Percentage of patients that are able to avoid adjuvant treatment | Percentage of patients, after treatment with R-RPLND, that are able to avoid chemotherapy and radiotherapy. | Study duration (5 years) | 
| Complications | 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. | Study duration (5 years) | 
| Quality of Life Surveys for Cancer Patients | Measured using the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire for cancer patients (EORTC QLQ-C30). | 4 months post-operatively | 
| Quality of Life Surveys for Testicular Cancer Patients | Measured using the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire for testicular cancer patients (EORTC QLQ-TC26). | 4 months post-operatively | 
| Return to work | Self-reported by the patient and queried at each study visit until return to work. | Study duration (5 years) | 
| Rate of ejaculation | Self-reported by the patient and queried at each study visit until ejaculation returns. | Study duration (5 years) | 
| Time of return of ejaculation | Defined as the duration of time between R-RPLND and study visit when patient self-reports return of ejaculatory function. | Study duration (5 years) | 
| Operative time | Operative time (minutes) for surgical metrics. | Duration of surgery (an average of 8 hours) | 
| Estimated blood loss | Estimated blood loss (mL) for surgical metrics. | Duration of surgery (an average of 8 hours) | 
| Transfusion rate | Transfusion rate (mL) for surgical metrics. | Duration of surgery (an average of 8 hours) | 
| Type of hemostatic agents | Type of hemostatic agents used during surgery for surgical metrics. | Duration of surgery (an average of 8 hours) | 
| Number of hemostatic agents | Number of hemostatic agents used during surgery for surgical metrics. | Duration of surgery (an average of 8 hours) | 
| Conversion rate to open surgery | Conversion rate to open surgery for surgical metrics. | Duration of surgery (an average of 8 hours) | 
| Number of lymph nodes resected | Number of lymph nodes resected | Duration of surgery (an average of 8 hours) | 
| Length of stay | Length of stay (in days) from the date of admission to date of discharge. | Post-operatively (an average of 2 days) |