Primary retroperitoneal lymph node surgery versus chemotherapy for good‑prognosis metastatic testicular cancer
Testicular Cancer Treatment: Assessing Quality of Life in Good Prognosis Metastastic Disease
This study will test whether primary RPLND (surgery) instead of standard chemotherapy leads to fewer side effects and better quality of life for men 18 and older with good‑prognosis metastatic testicular cancer.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 160 (estimated) |
| Ages | 18 Years and up |
| Sex | Male |
| Sponsor | Sahlgrenska University Hospital Academic / other |
| Drugs / interventions | chemotherapy |
| Locations | 1 site (Gothenburg, Göteborg) |
| Trial ID | NCT07498959 on ClinicalTrials.gov |
What this trial studies
This is a prospective, observational comparison of two treatment pathways for men with good‑prognosis metastatic germ cell tumors: primary retroperitoneal lymph node dissection (RPLND) versus three courses of BEP chemotherapy. Participants are enrolled into a surgery group (RPLND for seminoma stage IIA–IIB with up to 2 retroperitoneal nodes each ≤30 mm) or a chemotherapy group (3–4 courses of BEP for good‑prognosis seminoma or nonseminoma). The primary outcome is change in global health‑related quality of life measured by the EORTC QLQ‑C30 plus the testicular cancer module QLQ‑TC26, with additional patient‑reported and clinician‑reported secondary outcomes including fatigue, retrograde ejaculation, and complication rates. Recruitment is population‑based across eight centers in Sweden and Norway with follow‑up planned through 2 years to capture short‑ and longer‑term effects.
Who should consider this trial
Good fit: Men aged 18 or older with good‑prognosis metastatic germ cell tumors who are scheduled for primary RPLND for limited seminoma (≤2 retroperitoneal nodes, each ≤30 mm) or who are planned to receive 3–4 courses of BEP chemotherapy are the intended participants.
Not a fit: Patients with prior chemotherapy or prior RPLND, those with more extensive nodal disease than allowed by the criteria, or those unable to read/complete study questionnaires are unlikely to benefit from participation in this comparison.
Why it matters
Potential benefit: If successful, the approach could reduce the number of men exposed to the acute and long‑term toxicities of chemotherapy while maintaining effective cancer care.
How similar studies have performed: Guideline updates (SWENOTECA 2020) have moved toward recommending RPLND for selected seminoma based on surgical series and expert consensus, but prospective, patient‑reported quality‑of‑life comparisons versus chemotherapy remain limited, so this is a relatively novel, needed evaluation.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Gothenburg, Göteborg
- Sahlgrenska University Hospital — Gothenburg, Göteborg, Sweden (Recruiting)
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.