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New treatment option for Lymphadenopathy Retroperitoneal
Official title R-RPLND as First-line Treatment for Clinical Stage IIA/B Testicular Seminoma
ClinicalTrials.gov ID: NCT05345158
What this study is testing
- What it's testing
- 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.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older, men only
You may be able to join if
- 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...
- 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...
- 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...
You likely can't join if
- 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
See the full eligibility 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
- 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)
The study team makes the final eligibility decision.
Where it's taking place
- Toronto, Ontario, Canada
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling male, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Toronto, Ontario, Canada. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.