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Procedure
Robotic Surgery for Testicular Seminoma
N/A
Recruiting
Led By Robert Hamilton, MD
Research Sponsored by University Health Network, Toronto
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
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)
Curative treatment with RPLND is intended
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 5 years after rplnd
Awards & highlights
Study Summary
This trial will investigate whether a minimally invasive surgical approach is safe and effective for treating early stage seminoma.
Who is the study for?
This trial is for men with a specific type of testicular cancer (seminoma) that has spread to nearby lymph nodes but not beyond. They must have had surgery to remove the tumor, no metastasis in the chest, and meet certain criteria regarding tumor markers. It's not for those who've had extensive previous treatments or surgeries, other serious illnesses, or are unsuitable for robotic surgery.Check my eligibility
What is being tested?
The study tests a minimally invasive surgical technique called Robotic Retroperitoneal Lymph Node Dissection (R-RPLND) as an initial treatment option instead of chemotherapy or radiation. The goal is to see if this approach is safe and effective for stage IIA/B seminoma patients.See study design
What are the potential side effects?
While the side effects aren't detailed here, R-RPLND may include typical risks associated with minimally invasive surgery such as infection risk at incision sites, potential injury to surrounding organs or tissues during operation, bleeding complications, and postoperative pain.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I have a lymph node in my abdomen that is 5cm or smaller, confirmed by a scan.
Select...
I am planning to undergo surgery to remove lymph nodes for cancer treatment.
Select...
My testicular cancer was confirmed by a biopsy and fully removed.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 5 years after rplnd
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~5 years after rplnd
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Relapse Free Survival (RFS)
Secondary outcome measures
Cancer-specific survival (CSS)
Complications
Conversion rate to open surgery
+21 moreTrial Design
1Treatment groups
Experimental Treatment
Group I: Robotic Retroperitoneal Lymph Node DissectionExperimental Treatment1 Intervention
Robotic retroperitoneal lymph node dissection performed using the DaVinci robotic surgical system.
Find a Location
Who is running the clinical trial?
University Health Network, TorontoLead Sponsor
1,474 Previous Clinical Trials
485,017 Total Patients Enrolled
Robert Hamilton, MDPrincipal InvestigatorThe Princess Margaret Cancer Foundation
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have a lymph node in my abdomen that is 5cm or smaller, confirmed by a scan.I am planning to undergo surgery to remove lymph nodes for cancer treatment.My doctor says I can't have surgery using a robot.I have large lymph nodes in my abdomen.I have had chemotherapy or radiotherapy targeting the area behind my stomach.I have a serious illness that is not under control.My cancer was initially diagnosed at an early stage or has come back after being watched.My cancer has spread to distant lymph nodes or other organs.My cancer markers AFP and β-hCG are within safe limits.My testicular cancer was confirmed by a biopsy and fully removed.I have had surgery in the scrotal or abdominal area for reasons other than testicular cancer.I can understand and agree to the study's procedures and risks.
Research Study Groups:
This trial has the following groups:- Group 1: Robotic Retroperitoneal Lymph Node Dissection
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are there current opportunities to join this research project?
"According to clinicaltrials.gov, the recruitment phase of this medical trial is currently ongoing. It was first listed on May 1st 2022 and underwent its most recent edit on May 16th 2022."
Answered by AI
How many participants are included in this trial at most?
"Affirmative. According to clinicaltrials.gov, this research is currently accepting volunteers and was initially posted on May 1st 2022, with the most recent update occurring on May 16th of the same year. This study requires 25 test subjects to be admitted at a single location."
Answered by AI
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