Clinical trial NCT05345158: R-RPLND as First-line Treatment for Clinical Stage IIA/B Testicular Seminoma
Official title: Robotic Retroperitoneal Lymph Node Dissection (R-RPLND) as First-line Treatment for Clinical Stage IIA/B Testicular Seminoma
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Lymphadenopathy Retroperitoneal
Stage II Testicular Seminoma
Lead sponsor: University Health Network, Toronto
Sponsor class: OTHER
First posted: 2022-04-25
Enrollment: 25
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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-term complications and open retroperitoneum lymph node dissection (RPLND), the typical surgical approach for advanced testicular cancer, can be invasive and is fairly morbid. 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. The primary endpoint of this study is Relapse Free Survival (RFS) at 2 years and 5 years. Secondary endpoints of this study include characteristics of relapse, time to progression, percentage of patients that can avoid chemotherapy and radiation therapy after R-RPLND, perioperative, short-term and long-term complications, rate of retrograde ejaculation, time to return of ejaculation and return to work. Additionally, Quality of Life will be measured by a questionnaire administered at 4 months post-RPLND. Approximately 25 patients will be enrolled in this study and will be followed for at least 5 years.

The data will provide important insights into the safety and efficacy of performing R-RPLND for seminoma patients with stage IIA/B (or equivalent) disease. This information will be paramount to informing clinical practice and patterns of care for treating advanced seminoma and use of the robotic approach for RPLND.

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)

Primary outcomes:
measure: Relapse Free Survival (RFS)
timeFrame: 2 years after RPLND
measure: Relapse Free Survival (RFS)
timeFrame: 5 years after RPLND
Secondary outcomes:
measure: Rate of relapse
timeFrame: Study duration (5 years)
measure: Time to progression (TTP)
timeFrame: Study duration (5 years)
measure: Relapse in vs. out of surgical field
timeFrame: Study duration (5 years)
measure: Relapse tumour characteristics
timeFrame: Study duration (5 years)
measure: Mode of relapse detection
timeFrame: Study duration (5 years)
measure: Treatment burden
timeFrame: Study duration (5 years)
measure: IGCCCG risk classification
timeFrame: Study duration (5 years)
measure: Cancer-specific survival (CSS)
timeFrame: Study duration (5 years)
measure: Overall survival (OS)
timeFrame: Study duration (5 years)
measure: Percentage of patients that are able to avoid adjuvant treatment
timeFrame: Study duration (5 years)
measure: Complications
timeFrame: Study duration (5 years)
measure: Quality of Life Surveys for Cancer Patients
timeFrame: 4 months post-operatively
measure: Quality of Life Surveys for Testicular Cancer Patients
timeFrame: 4 months post-operatively
measure: Return to work
timeFrame: Study duration (5 years)
measure: Rate of ejaculation
timeFrame: Study duration (5 years)
measure: Time of return of ejaculation
timeFrame: Study duration (5 years)
measure: Operative time
timeFrame: Duration of surgery (an average of 8 hours)
measure: Estimated blood loss
timeFrame: Duration of surgery (an average of 8 hours)
measure: Transfusion rate
timeFrame: Duration of surgery (an average of 8 hours)
measure: Type of hemostatic agents
timeFrame: Duration of surgery (an average of 8 hours)
measure: Number of hemostatic agents
timeFrame: Duration of surgery (an average of 8 hours)
measure: Conversion rate to open surgery
timeFrame: Duration of surgery (an average of 8 hours)
measure: Number of lymph nodes resected
timeFrame: Duration of surgery (an average of 8 hours)
measure: Length of stay
timeFrame: Post-operatively (an average of 2 days)
Other outcomes:
Locations:
city: Toronto
country: Canada
facility: Princess Margaret Cancer Centre
state: Ontario
Study officials:
affiliation: The Princess Margaret Cancer Foundation
name: Robert Hamilton, MD
role: PRINCIPAL_INVESTIGATOR
References: