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Testicular CancerTESTIGONCT07498959

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

A study testing primary RPLND for low-stage metasatatic seminoma and 3 courses of chemotherapy; Blemocin, Etoposide and Platinum (BEP) in people with Testicular Cancer and Seminoma, run by Sahlgrenska University Hospital at 1 site in Sweden.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

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… Read more about this study

Who is it for?
Ages 18 years and older, men only
Conditions the study is for
Testicular Cancer, Seminoma, Quality of Life
What is being tested?
primary RPLND for low-stage metasatatic seminoma and 3 courses of chemotherapy; Blemocin, Etoposide and Platinum (BEP)
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
160 participants
Where
1 siteSweden
Study dates
19 Mar 2026to 25 Mar 2032
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • Men only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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)

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Sweden1 site, 1 recruiting
  • Sahlgrenska University Hospital

    Gothenburg, Göteborg, 413 45

    Anna LA Grenabo Bergdahl, ass prof, 0046 31 342 90 26, anna.grenabo@vgregion.se

    Hege Haugnes, Prof, 004777754342, Hege.Sagstuen.Haugnes@unn.no

    Recruiting

Other trials in Sweden

About this study

Official title: Testicular Cancer Treatment: Assessing Quality of Life in Good Prognosis Metastastic Disease

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?

Read the detailed 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:

  1. 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)
  2. 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:

  1. 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.

Being tested
primary RPLND for low-stage metasatatic seminoma, 3 courses of chemotherapy; Blemocin, Etoposide and Platinum (BEP)
Keywords
testicular cancer, seminoma, primary RPLND
Medical subject headings
Testicular Neoplasms, Seminoma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • primary RPLND for low-stage metasatatic seminomaProcedure or surgery

    surgical lymph node dissection

  • 3 courses of chemotherapy; Blemocin, Etoposide and Platinum (BEP)Drug

    Also called Systemic chemotherapy, Bleomycin, Etoposide, Platinum

    systemic tretament for good prognosis metastastic testicular cancer

Study groups in NCT07498959
Study groupRoleWhat they receive
Surgery groupActive comparatorUndergoing primary RPLND
Receives: Procedure: primary RPLND for low-stage metasatatic seminoma
Chemotherapy groupActive comparatorReceiving chemotherapy
Receives: Drug: 3 courses of chemotherapy; Blemocin, Etoposide and Platinum (BEP)

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. HRQOL after treatment as measured by the EORTC QLQ-C30 with the testicular cancer-specific supplement EORTC QLQ-TC26

    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

    The QLQ-C30 comprises both multi-item scales and single-item measures. These include five functional scales, three symptom scales, a global health status / QoL scale, and six single items. Each of the multi-item scales includes a different set of items - no item occurs in more than one scale.

    All of the scales and single-item measures range in score from 0 to 100. A high scale score represents a higher response level. Thus a high score for a functional scale represents a high / healthy level of functioning, a high score for the global health status / QoL represents a high QoL, but a high score for a symptom scale / item represents a high level of symptomatology / problems.

    Measured: 2 years

Secondary outcomes (5)
  1. Fatigue after RPLND vs. chemotherapy

    Differences in fatigue across study-groups as measured by the Fatigue Questionnaire (FQ). The FQ is an established, self-report fatigue questionnaire comprising 14 items that assess the intensity of fatigue-related symptoms. Each item was rated on a 4-point Likert scale (0 'better than usual', 1 'no more than usual', 2 'worse than usual', 3 'much worse than usual'). The FQ score is the sum of all items' scores (range 0-42).

    Measured: 2 years

  2. Ejaculation problems

    Differences across study-groups in patient-reported prevalence of retrograde ejaculation as assessed by two "supplementary" questions. These questions concern difficulties achieving ejaculation following sexual stimulation and whether the amount of semen is considered a problem. Answers are given on 4-point scales (no sexual stimulation has occurred, big difficulties (achieving ejaculation), small difficulties, no difficulties, and no sexual stimulation has occurred, large problem (amount of semen), small problem, no problem, respectively).

    Measured: 2 years

  3. Treatment related complications

    Rate of doctor-reported complications related to treatment in the study-groups. Journals are reviewed to gather information regarding the time and type of complication.

    Surgery group: Surgical complications are classified according to the Clavien-Dindo (CD) system, a standardised, 5-grade system used to grade surgical complications based on the level of therapeutic intervention required to manage them.

    Chemotherapy group: Complications following chemotherapy are classified according to the Common Terminology Criteria for Adverse Events, using a 1-5 scale to grade the severity of the event.

    Measured: 2 years

  4. Healt economy

    Differences in quality-adjusted life years across study groups as measured by the EQ-5D-5L tool, consisting of an index varying from 1 (full health) to 0 (dead), with scores below 0 indicating states worse than being dead. The index is evaluated at baseline (before start of treatment) and at 3, 6, 12 and 24 months thereafter.

    Measured: 2 years

  5. PFS

    Progression-free survival (PFS) are evaluated in both study groups. Medical records and national registers are used to identify recurrences of testicular cancer. Patients who do not have elevated markers or radiological evidence of disease recurrence or progression are considered free of recurrence or progression. The outcome will be dated and dicomotized (progression: yes/no).

    Measured: 10 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted27 Mar 2026
  2. Study start19 Mar 2026
  3. Primary completion25 Mar 2031 (estimated)
  4. Study completion25 Mar 2032 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
160 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07498959
Sponsor's protocol ID
Dnr 2024-08434-01
Acronym
TESTIGO
Status last verified
Mar 2026
First submitted
17 Mar 2026
Last updated
27 Mar 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: all IPD that underlie results in a publication

Publications

  • Thor 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.

    PubMed 38966804
  • Hiester 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.

    PubMed 36372627
  • Matulewicz 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.

    PubMed 37672753
  • Heidenreich 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.

    PubMed 37438222
  • Grenabo 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.

    PubMed 35950045
  • Daneshmand 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.

    PubMed 36913642
  • Hellesnes R, Myklebust TA, Fossa SD, Bremnes RM, Karlsdottir A, Kvammen O, Tandstad T, Wilsgaard T, Negaard HFS, Haugnes HS. Testicular Cancer in the Cisplatin Era: Causes of Death and Mortality Rates in a Population-Based Cohort. J Clin Oncol. 2021 Nov 10;39(32):3561-3573. doi: 10.1200/JCO.21.00637. Epub 2021 Aug 13.

    PubMed 34388002

Questions about this trial

What is this clinical trial studying?

A study testing primary RPLND for low-stage metasatatic seminoma and 3 courses of chemotherapy; Blemocin, Etoposide and Platinum (BEP) in people with Testicular Cancer and Seminoma, run by Sahlgrenska University Hospital at 1 site in Sweden.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 27 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

HRQOL after treatment as measured by the EORTC QLQ-C30 with the testicular cancer-specific supplement EORTC QLQ-TC26 (time frame: 2 years). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07498959, which also lists 7 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Mar 2026.

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