Lymphadenopathy RetroperitonealNCT05345158
R-RPLND as First-line Treatment for Clinical Stage IIA/B Testicular Seminoma
A study testing Robotic Retroperitoneal Lymph Node Dissection (RPLND) in people with Lymphadenopathy Retroperitoneal and Stage II Testicular Seminoma, run by University Health Network, Toronto at 1 site in Canada.
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. Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Lymphadenopathy Retroperitoneal, Stage II Testicular Seminoma
- What is being tested?
- Robotic Retroperitoneal Lymph Node Dissection (RPLND)
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- 1 siteCanada
- Study dates
- 23 Feb 2022to Nov 2030
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
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- Under the care of a uro-oncologist at Princess Margaret Cancer Centre
- Willing to comply with follow-up protocol
- Capable of providing informed consent
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Canada1 site, 1 recruiting
- Recruiting
Princess Margaret Cancer Centre
Toronto, Ontario, M5G 2M9
Robert Hamilton, MD, 416-946-2909
About this study
Official title: Robotic Retroperitoneal Lymph Node Dissection (R-RPLND) as First-line Treatment for Clinical Stage IIA/B Testicular Seminoma
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.
Read the 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.
- Being tested
- Robotic Retroperitoneal Lymph Node Dissection (RPLND)
- Medical subject headings
- Seminoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Robotic Retroperitoneal Lymph Node Dissection (RPLND)Procedure or surgery
Robotic RPLND performed using the DaVinci robotic surgical system.
| Study group | Role | What they receive |
|---|---|---|
| Robotic Retroperitoneal Lymph Node Dissection | Experimental | Robotic retroperitoneal lymph node dissection performed using the DaVinci robotic surgical system. Receives: Procedure: Robotic Retroperitoneal Lymph Node Dissection (RPLND) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 5 years after RPLND
Secondary outcomes (24)
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.
Measured: Study duration (5 years)
Time to progression (TTP)
TTP is defined as the time elapsed between date of R-RPLND and disease progression.
Measured: Study duration (5 years)
Relapse in vs. out of surgical field
Relapse is classified as in vs. out of R-RPLND surgical field.
Measured: Study duration (5 years)
Relapse tumour characteristics
Tumour size (in cm) and location
Measured: Study duration (5 years)
Mode of relapse detection
Mode of relapse detection (e.g., CT, serum tumour markers, physical exam, etc.).
Measured: Study duration (5 years)
Treatment burden
Number and type of treatment modalities
Measured: Study duration (5 years)
IGCCCG risk classification
International Germ Cell Cancer Collaborative Group (IGCCCG) risk classification
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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).
Measured: 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).
Measured: 4 months post-operatively
Return to work
Self-reported by the patient and queried at each study visit until return to work.
Measured: Study duration (5 years)
Rate of ejaculation
Self-reported by the patient and queried at each study visit until ejaculation returns.
Measured: 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.
Measured: Study duration (5 years)
Operative time
Operative time (minutes) for surgical metrics.
Measured: Duration of surgery (an average of 8 hours)
Estimated blood loss
Estimated blood loss (mL) for surgical metrics.
Measured: Duration of surgery (an average of 8 hours)
Transfusion rate
Transfusion rate (mL) for surgical metrics.
Measured: Duration of surgery (an average of 8 hours)
Type of hemostatic agents
Type of hemostatic agents used during surgery for surgical metrics.
Measured: Duration of surgery (an average of 8 hours)
Number of hemostatic agents
Number of hemostatic agents used during surgery for surgical metrics.
Measured: Duration of surgery (an average of 8 hours)
Conversion rate to open surgery
Conversion rate to open surgery for surgical metrics.
Measured: Duration of surgery (an average of 8 hours)
Number of lymph nodes resected
Number of lymph nodes resected
Measured: 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.
Measured: Post-operatively (an average of 2 days)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Apr 2022
- Study start23 Feb 2022
- Primary completionNov 2030 (estimated)
- Study completionNov 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lymphadenopathy RetroperitonealStudies of the same condition, open and under way.
- More trials run by University Health Network, TorontoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 25 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Health Network, Toronto
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Robert Hamilton, MD, Principal investigator, The Princess Margaret Cancer Foundation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05345158
- Sponsor's protocol ID
- 21-5242
- Status last verified
- Dec 2025
- First submitted
- 3 Mar 2022
- Last updated
- 19 Dec 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Robotic Retroperitoneal Lymph Node Dissection (R-RPLND) as First-line Treatment for Clinical Stage IIA/B Testicular Seminoma
- ClinicalTrials.gov ID
- NCT05345158
- Acronym / sponsor ID
- 21-5242
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 25 participants (estimated)
- Lead sponsor
- University Health Network, TorontoUniversity, hospital or other
- Study start
- 23 Feb 2022 (actual)
- Primary completion
- Nov 2030 (estimated)
- Study completion
- Nov 2030 (estimated)
- First posted
- 25 Apr 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Robotic Retroperitoneal Lymph Node Dissection | Experimental | Procedure: Robotic Retroperitoneal Lymph Node Dissection (RPLND)Robotic retroperitoneal lymph node dissection performed using the DaVinci robotic surgical system. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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)
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Robotic Retroperitoneal Lymph Node Dissection (RPLND)Robotic RPLND performed using the DaVinci robotic surgical system. | Procedure or surgery | Robotic Retroperitoneal Lymph Node Dissection |
Primary outcome
Relapse Free Survival (RFS)
Time frame: 2 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.
Relapse Free Survival (RFS)
Time frame: 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.
24 secondary outcomes
Rate of relapse
Time frame: Study duration (5 years)
Time to progression (TTP)
Time frame: Study duration (5 years)
Relapse in vs. out of surgical field
Time frame: Study duration (5 years)
Relapse tumour characteristics
Time frame: Study duration (5 years)
Mode of relapse detection
Time frame: Study duration (5 years)
Treatment burden
Time frame: Study duration (5 years)
IGCCCG risk classification
Time frame: Study duration (5 years)
Cancer-specific survival (CSS)
Time frame: Study duration (5 years)
Overall survival (OS)
Time frame: Study duration (5 years)
Percentage of patients that are able to avoid adjuvant treatment
Time frame: Study duration (5 years)
Complications
Time frame: Study duration (5 years)
Quality of Life Surveys for Cancer Patients
Time frame: 4 months post-operatively
Quality of Life Surveys for Testicular Cancer Patients
Time frame: 4 months post-operatively
Return to work
Time frame: Study duration (5 years)
Rate of ejaculation
Time frame: Study duration (5 years)
Time of return of ejaculation
Time frame: Study duration (5 years)
Operative time
Time frame: Duration of surgery (an average of 8 hours)
Estimated blood loss
Time frame: Duration of surgery (an average of 8 hours)
Transfusion rate
Time frame: Duration of surgery (an average of 8 hours)
Type of hemostatic agents
Time frame: Duration of surgery (an average of 8 hours)
Number of hemostatic agents
Time frame: Duration of surgery (an average of 8 hours)
Conversion rate to open surgery
Time frame: Duration of surgery (an average of 8 hours)
Number of lymph nodes resected
Time frame: Duration of surgery (an average of 8 hours)
Length of stay
Time frame: Post-operatively (an average of 2 days)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Dec 2025.
Related trials for Lymphadenopathy Retroperitoneal
Active, not recruiting
Retroperitoneal Lymph Node Dissection in Treating Patients With Testicular Seminoma
Lymphadenopathy, Stage I Testicular Seminoma
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Robert Hamilton, MD principal investigator
The Princess Margaret Cancer Foundation
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Robotic Retroperitoneal Lymph Node Dissection (RPLND) in people with Lymphadenopathy Retroperitoneal and Stage II Testicular Seminoma, run by University Health Network, Toronto at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 19 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Robert Hamilton, MD (416-946-2909, rob.hamilton@uhn.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Relapse Free Survival (RFS) (time frame: 2 years after RPLND). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Dec 2025.