Actively Recruiting

Phase Not Applicable
Age: 18Years +
MALE
ID07498959

Primary Retroperitoneal Lymph Node Dissection Versus Chemotherapy in Good-Prognosis Metastatic Testicular Cancer to Assess Quality of Life

Led by Sahlgrenska University Hospital · Updated on 2026-03-27

160

Participants Needed

1

Research Sites

52 weeks

Total Duration

On this page

Sponsors

S

Sahlgrenska University Hospital

Lead Sponsor

K

Karolinska University Hospital

Collaborating Sponsor

AI-Summary

What this Trial Is About

Researchers are evaluating the short- and long-term effects of treating men aged 18 and older with good-prognosis metastatic testicular cancer. The study compares two treatment approaches: primary retroperitoneal lymph node dissection (RPLND) for low-stage metastatic seminoma and three courses of chemotherapy. The main goal is to find out whether RPLND reduces the risk of side effects compared to chemotherapy while considering quality of life over two years and longer-term outcomes. The study includes two groups: one undergoing surgery with primary RPLND for seminoma stage IIA-IIB with limited lymph node involvement, and a control group receiving three doses of chemotherapy with Blemocin, Etoposide, and Platinum (BEP) for good-prognosis metastatic seminoma or nonseminoma. Treatments are delivered as scheduled, with the surgery performed either open or minimally invasive, and chemotherapy given systemically in three to four courses. Participants will be followed from baseline through multiple timepoints: 3 months, 6 months, 1 year, and 2 years after treatment start. Assessments include quality of life measured by EORTC QLQ-C30 with a testicular cancer supplement, fatigue levels, prevalence of retrograde ejaculation, doctor-reported treatment complications, quality-adjusted life years, and progression-free survival with follow-up up to 10 years. The study is population-based and conducted at several centers in Sweden and Norway, with data collected through questionnaires and medical evaluations.

CONDITIONS

Brief Title

Primary RPLND Versus Systemic Chemotherapy in Good-prognosis Metastatic Testicular Cancer

Who Can Participate

Age: 18Years +
MALE

Eligibility Criteria

Eligible

You may qualify if you...

  • Male patients 18 years or older
  • Scheduled for primary RPLND due to seminoma stage IIA or IIB with up to 2 lymph nodes smaller than 30 mm
  • Scheduled for primary RPLND due to retroperitoneal relapse of seminoma with similar lymph node criteria
  • Scheduled for 3-4 courses of chemotherapy for newly diagnosed good-prognosis metastatic germ cell tumor (seminoma or nonseminoma)
Not Eligible

You will not qualify if you...

  • Previous chemotherapy including adjuvant treatment at diagnosis
  • Previous retroperitoneal lymph node dissection (RPLND)
  • Inability to read, sign informed consent, or understand questionnaires

AI-Screening

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Surgery

Duration - Single treatment event

Participants scheduled for primary Retroperitoneal Lymph Node Dissection (RPLND) undergo surgical lymph node dissection to treat metastatic testicular cancer.

1 surgery visit (in-person)

Treatment

Duration - Duration of 3 chemotherapy courses

Participants receiving systemic chemotherapy are treated with 3 courses of Blemocin, Etoposide, and Platinum (BEP) for metastatic testicular cancer.

3 chemotherapy visits (in-person)

Follow-up

Duration - Up to 2 years

Participants are monitored to assess quality of life, fatigue, complications, and progression-free survival after treatment.

Visits at 3 months, 6 months, 1 year, and 2 years post-treatment

Trial Site Locations

Total: 1 location

1

Sahlgrenska University Hospital

Gothenburg, Göteborg, Sweden, 413 45

Actively Recruiting

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How is the study designed?

Study Type

INTERVENTIONAL

Masking

SINGLE

Allocation

NON_RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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Published Research Related To This Trial

Primary Retroperitoneal Lymph Node Dissection as Treatment for Low-volume Metastatic Seminoma in a Population-based Cohort: The Swedish Norwegian Testicular Cancer Group Experience.

Anna Thor, Helene F S Negaard, Anna Grenabo Bergdahl...

https://pubmed.ncbi.nlm.nih.gov/38966804

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).

Andreas Hiester, Yue Che, Achim Lusch...

https://pubmed.ncbi.nlm.nih.gov/36372627

Retroperitoneal Lymph Node Dissection in Clinical Stage IIA/B Metastatic Seminoma: Results of the COlogne Trial of Retroperitoneal Lymphadenectomy In Metastatic Seminoma (COTRIMS).

Axel Heidenreich, Pia Paffenholz, Florian Hartmann...

https://pubmed.ncbi.nlm.nih.gov/37438222

Surgery in Early Metastatic Seminoma: A Phase II Trial of Retroperitoneal Lymph Node Dissection for Testicular Seminoma With Limited Retroperitoneal Lymphadenopathy.

Siamak Daneshmand, Clint Cary, Timothy Masterson...

https://pubmed.ncbi.nlm.nih.gov/36913642

Testicular Cancer in the Cisplatin Era: Causes of Death and Mortality Rates in a Population-Based Cohort.

Ragnhild Hellesnes, Tor Åge Myklebust, Sophie D Fosså...

https://pubmed.ncbi.nlm.nih.gov/34388002