R-RPLND as First-line Treatment for Clinical Stage IIA/B Testicular Seminoma
- Conditions
- Lymphadenopathy RetroperitonealStage II Testicular Seminoma
- Registration Number
- NCT05345158
- Lead Sponsor
- University Health Network, Toronto
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Male
- Target Recruitment
- 25
Inclusion Criteria:<br><br> - Histologically confirmed seminomatous testicular germ cell tumour with negative<br> margins on radical orchiectomy<br><br> - Lymphadenopathy in the retroperitoneum: at least one lymph node =5cm in size (in the<br> transverse plane) detected on contrast CT scan or MRI (CS IIA/B; or active<br> surveillance relapse with CS IIA/B equivalent)<br><br> - CT Chest negative for metastasis<br><br> - Patients qualify for this trial under the following scenarios: (1) initial diagnosis<br> of clinical or stage IIA/B disease or (2) recurrence after surveillance for clinical<br> stage I disease<br><br> - Patients with serum tumour marker elevation are eligible if the elevated marker does<br> not exceed the following cut-offs within 10 days of RPLND: AFP (< 2.5 x ULN) and<br> ß-hCG (<5 IU/L)<br><br> - Curative treatment with RPLND is intended<br><br> - Under the care of a uro-oncologist at Princess Margaret Cancer Centre<br><br> - Willing to comply with follow-up protocol<br><br> - Capable of providing informed consent<br><br>Exclusion Criteria:<br><br> - Retroperitoneal lymphadenopathy >5cm in the transverse plane (CS IIC)<br><br> - Metastasis to distant lymph nodes or any organ (CS III)<br><br> - History of chemotherapy or radiotherapy to the retroperitoneum<br><br> - Patients with previous scrotal or retroperitoneal surgery for indication other than<br> germ cell tumour<br><br> - Patients in reduced general condition, with uncontrolled intercurrent illnesses, or<br> with life-threatening disease<br><br> - Patients with psychiatric illnesses that would limit compliance with study<br> requirements<br><br> - Unsuitable for robotic surgery (determined by treating physician)
Not provided
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Relapse Free Survival (RFS);Relapse Free Survival (RFS)
- Secondary Outcome Measures
Name Time Method Rate of relapse;Time to progression (TTP);Relapse in vs. out of surgical field;Relapse tumour characteristics;Mode of relapse detection;Treatment burden;IGCCCG risk classification;Cancer-specific survival (CSS);Overall survival (OS);Percentage of patients that are able to avoid adjuvant treatment;Complications;Quality of Life Surveys for Cancer Patients;Quality of Life Surveys for Testicular Cancer Patients;Return to work;Rate of ejaculation;Time of return of ejaculation;Operative time;Estimated blood loss;Transfusion rate;Type of hemostatic agents;Number of hemostatic agents;Conversion rate to open surgery;Number of lymph nodes resected;Length of stay