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

Not Applicable

Recruiting

• Conditions: Stage II Testicular Seminoma; Lymphadenopathy Retroperitoneal
• Interventions: Procedure: Robotic Retroperitoneal Lymph Node Dissection (RPLND)

• Registration Number: NCT05345158
• Lead Sponsor: University Health Network, Toronto

Brief Summary

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

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 Timeline

• Study Start: 2022-02-23
• Study First Submitted: 2022-03-03
• Study First Submitted QC: 2022-04-22
• Study First Posted: 2022-04-25
• Status Verified: 2024-08
• Last Update Submitted: 2024-08-19
• Last Update Posted: 2024-08-21
• Primary Completion: 2030-11
• Study Completion: 2030-11

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Male
• Target Recruitment: 25

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

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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)

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Robotic Retroperitoneal Lymph Node Dissection	Robotic Retroperitoneal Lymph Node Dissection (RPLND)	Robotic retroperitoneal lymph node dissection performed using the DaVinci robotic surgical system.

Primary Outcome Measures

Name	Time	Method
Relapse Free Survival (RFS)	5 years after RPLND	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.

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Princess Margaret Cancer Centre; 🇨🇦 Toronto, Ontario, Canada