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

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.

Trial Description

Primary Outcome:

  • Relapse Free Survival (RFS)
  • Relapse Free Survival (RFS)
Secondary Outcome:
  • Rate of relapse
  • Time to progression (TTP)
  • Relapse in vs. out of surgical field
  • Relapse tumour characteristics
  • Mode of relapse detection
  • Treatment burden
  • IGCCCG risk classification
  • Cancer-specific survival (CSS)
  • Overall survival (OS)
  • Percentage of patients that are able to avoid adjuvant treatment
  • Complications
  • Quality of Life Surveys for Cancer Patients
  • Quality of Life Surveys for Testicular Cancer Patients
  • Return to work
  • Rate of ejaculation
  • Time of return of ejaculation
  • Operative time
  • Estimated blood loss
  • Transfusion rate
  • Type of hemostatic agents
  • Number of hemostatic agents
  • Conversion rate to open surgery
  • Number of lymph nodes resected
  • Length of stay

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.

View this trial on ClinicalTrials.gov

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Resources

Canadian Cancer Society

These resources are provided in partnership with the Canadian Cancer Society