Primary RPLND Versus Systemic Chemotherapy in Good-prognosis Metastatic Testicular Cancer
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexMale
Age18+
SponsorSahlgrenska University Hospital
About this trial
The goal of this prospective observational study is to learn about the short- and long-term effects of treating men over the age of 18 with good prognosis metastatic testicular cancer with either primary retropertioneal lymph node dissection, RPLND, (for low-stage metastastic seminoma) or three doses of chemotherapy for metastastic seminoma or nonseminoma. The main question it aims to answer is:
Does primary RPLND lower the risk of side-effects compared to receiving chemotherapy?
Eligibility criteria
Qualifiers
Patients ≥18 years undergoing an open or minimally invasive primary retroperitoneal lymph node dissection (RPLND) due to seminoma stage II A/B (maximum 2 nodes, <30 mm in any dimension)
Patients undergoing an open or minimally invasive primary RPLND due to a retroperitoneal relapse of seminoma (maximum 2 nodes, <30 mm in any dimension)
Patients ≥18 years scheduled for 3-4 courses of chemotherapy due to a newly diagnosed good-prognosis metastatic germ cell tumor (nonseminoma or seminoma)
Disqualifiers
Previous chemotherapy (including adjuvant chemotherapy at diagnosis)
Previous RPLND
Practical considerations, such as not being able to read and sign informed consent or understand the questionnaires
Trial design
Treatments tested in this trial
- primary RPLND for low-stage metasatatic seminoma
- 3 courses of chemotherapy; Blemocin, Etoposide and Platinum (BEP)
Treatment groups
160 Participants
are divided into 2 treatment groupsSponsors and collaborators
Sahlgrenska University Hospital
Lead sponsor
Karolinska University Hospital
Collaborator
Haukeland University Hospital
Collaborator
University Hospital of North Norway
Collaborator
Oslo University Hospital
Collaborator
Trondheim University Hospital
Collaborator
Uppsala University Hospital
Collaborator
University Hospital, Umeå
Collaborator
Lund University Hospital
Collaborator
Source ClinicalTrials.gov