Clinical trial · Interventional
Primary RPLND Versus Systemic Chemotherapy in Good-prognosis Metastatic Testicular Cancer
Testicular Cancer Treatment: Assessing Quality of Life in Good Prognosis Metastastic Disease
NCT07498959CI-TRIAL-00106578TESTIGOrecruitingN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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?
Conditions
Conditions (5)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| De-escalation | — | UNRESOLVED | — |
| Quality of Life | — | UNRESOLVED | — |
| RPLND | — | UNRESOLVED | — |
| Seminoma | Seminoma | ONTOLOGY_EXACT | 0.98 |
| Testicular Cancer | Malignant Testicular Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| 3 courses of chemotherapy; Blemocin, Etoposide and Platinum (BEP) | Drug | — | UNRESOLVED |
| primary RPLND for low-stage metasatatic seminoma | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- Surgery group
- description
- Undergoing primary RPLND
- interventionNames
- Procedure: primary RPLND for low-stage metasatatic seminoma
- type
- ACTIVE_COMPARATOR
- label
- Chemotherapy group
- description
- Receiving chemotherapy
- interventionNames
- Drug: 3 courses of chemotherapy; Blemocin, Etoposide and Platinum (BEP)
Primary outcomes (1)
- measure
- HRQOL after treatment as measured by the EORTC QLQ-C30 with the testicular cancer-specific supplement EORTC QLQ-TC26
- timeFrame
- 2 years
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (7)
- BACKGROUNDThor A, Negaard HFS, Grenabo Bergdahl A, Almas B, Melsen Larsen S, Lundgren PO, Gerdtsson A, Halvorsen D, Johannsdottir B, Jansson AK, Hellstrom M, Wahlqvist R, Langberg CW, Hedlund A, Akre O, Glimelius I, Stahl O, Haugnes HS, Cohn-Cedermark G, Kjellman A, Tandstad T. Primary Retroperitoneal Lymph Node Dissection as Treatment for Low-volume Metastatic Seminoma in a Population-based Cohort: The Swedish Norwegian Testicular Cancer Group Experience. Eur Urol Open Sci. 2024 Jun 11;65:13-19. doi: 10.1016/j.euros.2024.05.006. eCollection 2024 Jul. PMID 38966804
- BACKGROUNDHiester A, Che Y, Lusch A, Kuss O, Niegisch G, Lorch A, Arsov C, Albers P. Phase 2 Single-arm Trial of Primary Retroperitoneal Lymph Node Dissection in Patients with Seminomatous Testicular Germ Cell Tumors with Clinical Stage IIA/B (PRIMETEST). Eur Urol. 2023 Jul;84(1):25-31. doi: 10.1016/j.eururo.2022.10.021. Epub 2022 Nov 10. PMID 36372627
- BACKGROUNDMatulewicz RS, Benfante N, Funt SA, Feldman DR, Carver B, Doudt A, Knezevic A, Sheinfeld J. Primary Retroperitoneal Lymph Node Dissection for Seminoma Metastatic to the Retroperitoneum. J Urol. 2024 Jan;211(1):80-89. doi: 10.1097/JU.0000000000003697. Epub 2023 Sep 6. PMID 37672753
- BACKGROUNDHeidenreich A, Paffenholz P, Hartmann F, Seelemeyer F, Pfister D. Retroperitoneal Lymph Node Dissection in Clinical Stage IIA/B Metastatic Seminoma: Results of the COlogne Trial of Retroperitoneal Lymphadenectomy In Metastatic Seminoma (COTRIMS). Eur Urol Oncol. 2024 Feb;7(1):122-127. doi: 10.1016/j.euo.2023.06.004. Epub 2023 Jul 10. PMID 37438222
- BACKGROUNDGrenabo Bergdahl A, Mansson M, Holmberg G, Fovaeus M. Robotic retroperitoneal lymph node dissection for testicular cancer at a national referral centre. BJUI Compass. 2022 Mar 31;3(5):363-370. doi: 10.1002/bco2.149. eCollection 2022 Sep. PMID 35950045
- BACKGROUNDDaneshmand S, Cary C, Masterson T, Einhorn L, Adra N, Boorjian SA, Kollmannsberger C, Schuckman A, So A, Black P, Bagrodia A, Skinner E, Alemozaffar M, Brand T, Eggener S, Pierorazio P, Stratton K, Nappi L, Nichols C, Luo C, Li M, Hu B. Surgery in Early Metastatic Seminoma: A Phase II Trial of Retroperitoneal Lymph Node Dissection for Testicular Seminoma With Limited Retroperitoneal Lymphadenopathy. J Clin Oncol. 2023 Jun 1;41(16):3009-3018. doi: 10.1200/JCO.22.00624. Epub 2023 Mar 13.