- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05345158
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
Study Overview
Status
Intervention / Treatment
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 Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Robert Hamilton, MD
- Phone Number: 416-946-2909
- Email: rob.hamilton@uhn.ca
Study Contact Backup
- Name: Kopika Kuhathaas, BSc
- Phone Number: 416-946-2282
- Email: kopika.kuhathaas@uhn.ca
Study Locations
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Ontario
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Toronto, Ontario, Canada, M5G 2M9
- Recruiting
- Princess Margaret Cancer Centre
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Contact:
- Robert Hamilton, MD
- Phone Number: 416-946-2909
-
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
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)
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Robotic Retroperitoneal Lymph Node Dissection
Robotic retroperitoneal lymph node dissection performed using the DaVinci robotic surgical system.
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Robotic RPLND performed using the DaVinci robotic surgical system.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Relapse Free Survival (RFS)
Time Frame: 2 years after RPLND
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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.
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2 years after RPLND
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Relapse Free Survival (RFS)
Time Frame: 5 years after RPLND
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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.
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5 years after RPLND
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Rate of relapse
Time Frame: 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.
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Study duration (5 years)
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Time to progression (TTP)
Time Frame: Study duration (5 years)
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TTP is defined as the time elapsed between date of R-RPLND and disease progression.
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Study duration (5 years)
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Relapse in vs. out of surgical field
Time Frame: Study duration (5 years)
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Relapse is classified as in vs. out of R-RPLND surgical field.
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Study duration (5 years)
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Relapse tumour characteristics
Time Frame: Study duration (5 years)
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Tumour size (in cm) and location
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Study duration (5 years)
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Mode of relapse detection
Time Frame: Study duration (5 years)
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Mode of relapse detection (e.g., CT, serum tumour markers, physical exam, etc.).
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Study duration (5 years)
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Treatment burden
Time Frame: Study duration (5 years)
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Number and type of treatment modalities
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Study duration (5 years)
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IGCCCG risk classification
Time Frame: Study duration (5 years)
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International Germ Cell Cancer Collaborative Group (IGCCCG) risk classification
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Study duration (5 years)
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Cancer-specific survival (CSS)
Time Frame: Study duration (5 years)
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Defined as the length of time from date of R-RPLND to the date of death from disease.
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Study duration (5 years)
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Overall survival (OS)
Time Frame: Study duration (5 years)
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Defined as the length of time from the date of R-RPLND until death due to any cause.
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Study duration (5 years)
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Percentage of patients that are able to avoid adjuvant treatment
Time Frame: Study duration (5 years)
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Percentage of patients, after treatment with R-RPLND, that are able to avoid chemotherapy and radiotherapy.
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Study duration (5 years)
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Complications
Time Frame: Study duration (5 years)
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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
Time Frame: 4 months post-operatively
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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
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Quality of Life Surveys for Testicular Cancer Patients
Time Frame: 4 months post-operatively
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Measured using the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire for testicular cancer patients (EORTC QLQ-TC26).
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4 months post-operatively
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Return to work
Time Frame: Study duration (5 years)
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Self-reported by the patient and queried at each study visit until return to work.
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Study duration (5 years)
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Rate of ejaculation
Time Frame: Study duration (5 years)
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Self-reported by the patient and queried at each study visit until ejaculation returns.
|
Study duration (5 years)
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Time of return of ejaculation
Time Frame: Study duration (5 years)
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Defined as the duration of time between R-RPLND and study visit when patient self-reports return of ejaculatory function.
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Study duration (5 years)
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Operative time
Time Frame: Duration of surgery (an average of 8 hours)
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Operative time (minutes) for surgical metrics.
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Duration of surgery (an average of 8 hours)
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Estimated blood loss
Time Frame: Duration of surgery (an average of 8 hours)
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Estimated blood loss (mL) for surgical metrics.
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Duration of surgery (an average of 8 hours)
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Transfusion rate
Time Frame: Duration of surgery (an average of 8 hours)
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Transfusion rate (mL) for surgical metrics.
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Duration of surgery (an average of 8 hours)
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Type of hemostatic agents
Time Frame: Duration of surgery (an average of 8 hours)
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Type of hemostatic agents used during surgery for surgical metrics.
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Duration of surgery (an average of 8 hours)
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Number of hemostatic agents
Time Frame: Duration of surgery (an average of 8 hours)
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Number of hemostatic agents used during surgery for surgical metrics.
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Duration of surgery (an average of 8 hours)
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Conversion rate to open surgery
Time Frame: Duration of surgery (an average of 8 hours)
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Conversion rate to open surgery for surgical metrics.
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Duration of surgery (an average of 8 hours)
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Number of lymph nodes resected
Time Frame: Duration of surgery (an average of 8 hours)
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Number of lymph nodes resected
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Duration of surgery (an average of 8 hours)
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Length of stay
Time Frame: Post-operatively (an average of 2 days)
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Length of stay (in days) from the date of admission to date of discharge.
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Post-operatively (an average of 2 days)
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Collaborators and Investigators
Investigators
- Principal Investigator: Robert Hamilton, MD, The Princess Margaret Cancer Foundation
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 21-5242
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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