Status:
RECRUITING
R-RPLND as First-line Treatment for Clinical Stage IIA/B Testicular Seminoma
Lead Sponsor:
University Health Network, Toronto
Conditions:
Lymphadenopathy Retroperitoneal
Stage II Testicular Seminoma
Eligibility:
MALE
18+ years
Phase:
NA
Brief 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 I...
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-te...
Eligibility Criteria
Inclusion
- 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
- 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)
Key Trial Info
Start Date :
February 23 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
November 1 2030
Estimated Enrollment :
25 Patients enrolled
Trial Details
Trial ID
NCT05345158
Start Date
February 23 2022
End Date
November 1 2030
Last Update
December 19 2025
Active Locations (1)
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1
Princess Margaret Cancer Centre
Toronto, Ontario, Canada, M5G 2M9