RecruitingNot ApplicableNCT05345158
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
Sponsor
University Health Network, Toronto
Enrollment
25 participants
Start Date
Feb 23, 2022
Study Type
INTERVENTIONAL
Conditions
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. R-RPLND will be trialed as an alternative to chemotherapy, radiation therapy (for seminoma patients) and open RPLND in this study.
Eligibility
Sex: MALEMin Age: 18 Years
Inclusion Criteria9
- 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 Criteria7
- 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)
Interventions
PROCEDURERobotic Retroperitoneal Lymph Node Dissection (RPLND)
Robotic RPLND performed using the DaVinci robotic surgical system.
Locations(1)
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NCT05345158