Background & rationale
The optimal treatment for patients with stage IIA/B seminoma is unknown. These patients have previously been treated with either chemotherapy or radiation. More recently, several international studies have begun to evaluate the outcome of primary RPLND as an alternative that may spare patients the long-term toxicity of systemic treatment and radiation.
SWENOTECA-TESTIGO sets out to compare patient-reported quality of life and treatment-related morbidity between a surgical approach and standard chemotherapy in good-prognosis disease — generating the evidence needed to guide treatment choice for this group.
Study design
Patients aged 18+ undergoing open or minimally invasive primary RPLND for seminoma stage IIA/B (<3 nodes, <30 mm in any dimension). Relapses are also allowed.
Patients aged 18+ scheduled for 3–4 courses of chemotherapy for newly diagnosed good-prognosis metastatic germ cell tumour (non-seminoma or seminoma). No previous chemotherapy allowed.
Eighty patients are planned in each group. All participants complete health-related quality-of-life (HRQoL) questionnaires at baseline and at 3 months, 6 months, 1 year and 2 years.
Endpoints
- Fatigue, measured by the Fatigue Questionnaire (FQ)
- Patient-reported prevalence of retrograde ejaculation
- Doctor-reported treatment-related complications
- Quality-adjusted life years (EQ-5D-5L)
- Progression-free survival in both groups
HRQoL and clinical variables are collected on a fixed schedule of assessments for both groups, with stratification for surgical modality, chemotherapy choice, age, hormone levels, comorbidity and other factors.