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

Recruitment & Eligibility

Status: Recruiting

Sex: Male

Target Recruitment: 25

Inclusion Criteria

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)

Exclusion Criteria

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