NCT05345158 R-RPLND as First-line Treatment for Clinical Stage IIA/B Testicular Seminoma
| NCT ID | NCT05345158 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University Health Network, Toronto |
| Condition | Lymphadenopathy Retroperitoneal |
| Study Type | INTERVENTIONAL |
| Enrollment | 25 participants |
| Start Date | 2022-02-23 |
| Primary Completion | 2030-11 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 25 participants in total. It began in 2022-02-23 with a primary completion date of 2030-11.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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 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 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 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)
Contact & Investigator
Robert Hamilton, MD
PRINCIPAL INVESTIGATOR
The Princess Margaret Cancer Foundation
Frequently Asked Questions
Who can join the NCT05345158 clinical trial?
This trial is open to male participants only, aged 18 Years or older, studying Lymphadenopathy Retroperitoneal. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05345158 currently recruiting?
Yes, NCT05345158 is actively recruiting participants. Contact the research team at rob.hamilton@uhn.ca for enrollment information.
Where is the NCT05345158 trial being conducted?
This trial is being conducted at Toronto, Canada.
Who is sponsoring the NCT05345158 clinical trial?
NCT05345158 is sponsored by University Health Network, Toronto. The principal investigator is Robert Hamilton, MD at The Princess Margaret Cancer Foundation. The trial plans to enroll 25 participants.