Overview
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?
Description
The current SWENOTECA guidelines from 2020 state that patients with seminoma stage IIA-IIB with \<3 lymph nodes \<30 mm in any dimension should be recommended a primary RPLND rather than the previously considered standard treatment, chemotherapy. The rationale behind this change is to reduce the number of patients at risk of acute and long-term side effects from chemotherapy. We aim to perform a quality-of-life assessment to determine whether the change from chemotherapy to surgery is justified regarding short- and long-term (2 years) quality-of-life.
Two study groups are formed:
- Surgery group consisting of patients scheduled for a primary RPLND due to a CS IIa/b seminoma (maximum 2 nodes, maximum 30 mm in any diameter)
- Chemotherapy group (control group) of patients receiving 3 doses of BEP due to a good prognosis seminoma or nonseminoma.
Patients will be recrutied at eight study centers in Sweden and Norway. Since RPLND is centralized in Sweden and Norway, the study will be population-based.
Primary outcome is:
- Changes across study-groups in global HRQOL after treatment as measured by the EORTC QLQ-C30 with the testicular cancer-specific supplement EORTC QLQ-TC26.
Secondary outcomes are:
2. Differences in fatigue across study-groups as measured by the Fatigue Questionnaire (FQ).
3. Differences across study-groups in patient-reported prevalence of retrograde ejaculation as assessed by supplementary questions.
4. Rate of doctor-reported complications related to treatment in the study-groups.
5. Differences in quality-adjusted life years across study-groups as measured by the EQ-5D-5L tool
6. PFS in both study-groups (longer follow-up than 2 years permitted)
Data will be assessed at baseline, at 3 months after start of treatment, at 6 months, 1 year and 2 years.
Eligibility
Inclusion Criteria:
- 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)
Exclusion Criteria:
- 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
