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

Lymphadenopathy Retroperitoneal Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05345158
• Other study ID #: 21-5242
• Status: Recruiting
• Phase: N/A
• Start date: February 23, 2022
• Est. completion date: November 2030

Study information

• Verified date: July 2023
• Source: University Health Network, Toronto
• Contact: Robert Hamilton, MD
• Phone: 416-946-2909
• Email: rob.hamilton[@]uhn.ca
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 25
• Est. completion date: November 2030
• Est. primary completion date: November 2030
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years and older

Eligibility

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 ß-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)

Related Conditions & MeSH terms

• Lymphadenopathy
• Lymphadenopathy Retroperitoneal
• Seminoma
• Stage II Testicular Seminoma

Intervention

Procedure:
• Robotic Retroperitoneal Lymph Node Dissection (RPLND)
Robotic RPLND performed using the DaVinci robotic surgical system.

Locations

Country	Name	City	State
Canada	Princess Margaret Cancer Centre	Toronto	Ontario

Sponsors (1)

Lead Sponsor	Collaborator
University Health Network, Toronto

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	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)
Secondary	Time to progression (TTP)	TTP is defined as the time elapsed between date of R-RPLND and disease progression.	Study duration (5 years)
Secondary	Relapse in vs. out of surgical field	Relapse is classified as in vs. out of R-RPLND surgical field.	Study duration (5 years)
Secondary	Relapse tumour characteristics	Tumour size (in cm) and location	Study duration (5 years)
Secondary	Mode of relapse detection	Mode of relapse detection (e.g., CT, serum tumour markers, physical exam, etc.).	Study duration (5 years)
Secondary	Treatment burden	Number and type of treatment modalities	Study duration (5 years)
Secondary	IGCCCG risk classification	International Germ Cell Cancer Collaborative Group (IGCCCG) risk classification	Study duration (5 years)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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
Secondary	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
Secondary	Return to work	Self-reported by the patient and queried at each study visit until return to work.	Study duration (5 years)
Secondary	Rate of ejaculation	Self-reported by the patient and queried at each study visit until ejaculation returns.	Study duration (5 years)
Secondary	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)
Secondary	Operative time	Operative time (minutes) for surgical metrics.	Duration of surgery (an average of 8 hours)
Secondary	Estimated blood loss	Estimated blood loss (mL) for surgical metrics.	Duration of surgery (an average of 8 hours)
Secondary	Transfusion rate	Transfusion rate (mL) for surgical metrics.	Duration of surgery (an average of 8 hours)
Secondary	Type of hemostatic agents	Type of hemostatic agents used during surgery for surgical metrics.	Duration of surgery (an average of 8 hours)
Secondary	Number of hemostatic agents	Number of hemostatic agents used during surgery for surgical metrics.	Duration of surgery (an average of 8 hours)
Secondary	Conversion rate to open surgery	Conversion rate to open surgery for surgical metrics.	Duration of surgery (an average of 8 hours)
Secondary	Number of lymph nodes resected	Number of lymph nodes resected	Duration of surgery (an average of 8 hours)
Secondary	Length of stay	Length of stay (in days) from the date of admission to date of discharge.	Post-operatively (an average of 2 days)