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R-RPLND as First-line Treatment for Clinical Stage IIA/B Testicular Seminoma
RECRUITINGN/ASponsored by University Health Network, Toronto
Actively Recruiting
PhaseN/A
SponsorUniversity Health Network, Toronto
Started2022-02-23
Est. completion2030-11
Eligibility
Age18 Years+
SexMALE
Healthy vol.Accepted
View on ClinicalTrials.gov →
NCT05345158
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
Age: 18 Years+Sex: MALEHealthy volunteers accepted
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 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 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)
Conditions3
CancerLymphadenopathy RetroperitonealStage II Testicular Seminoma
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Actively Recruiting
PhaseN/A
SponsorUniversity Health Network, Toronto
Started2022-02-23
Est. completion2030-11
Eligibility
Age18 Years+
SexMALE
Healthy vol.Accepted
View on ClinicalTrials.gov →
NCT05345158