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

March 24, 2026 updated by: Anna Grenabo Bergdahl, Sahlgrenska University Hospital

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?

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Estimated)

160

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Sweden
    • Göteborg
      • Gothenburg, Göteborg, Sweden, 413 45
        • Recruiting
        • Sahlgrenska University Hospital
        • Contact:
        • Contact:
        • Principal Investigator:
          • Hege Haugnes, professor

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Surgery group
Undergoing primary RPLND
Procedure: primary RPLND for low-stage metasatatic seminoma
surgical lymph node dissection
Active Comparator: Chemotherapy group
Receiving chemotherapy
Drug: 3 courses of chemotherapy; Blemocin, Etoposide and Platinum (BEP)
systemic tretament for good prognosis metastastic testicular cancer
Other Names:
  • Systemic chemotherapy
  • Bleomycin, Etoposide, Platinum

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
HRQOL after treatment as measured by the EORTC QLQ-C30 with the testicular cancer-specific supplement EORTC QLQ-TC26
Time Frame: 2 years

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.
2 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Fatigue after RPLND vs. chemotherapy
Time Frame: 2 years
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).
2 years
Ejaculation problems
Time Frame: 2 years
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).
2 years
Treatment related complications
Time Frame: 2 years

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.
2 years
Healt economy
Time Frame: 2 years
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.
2 years
PFS
Time Frame: 10 years
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).
10 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sahlgrenska University Hospital

Collaborators

Karolinska University Hospital
Oslo University Hospital
University Hospital of North Norway
Haukeland University Hospital
Lund University Hospital
Uppsala University Hospital
Trondheim University Hospital
Norrlands Universitetssjukhus, Umea, Sweden

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 19, 2026

Primary Completion (Estimated)

March 25, 2031

Study Completion (Estimated)

March 25, 2032

Study Registration Dates

First Submitted

March 17, 2026

First Submitted That Met QC Criteria

March 24, 2026

First Posted (Actual)

March 27, 2026

Study Record Updates

Last Update Posted (Actual)

March 27, 2026

Last Update Submitted That Met QC Criteria

March 24, 2026

Last Verified

March 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Dnr 2024-08434-01

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

all IPD that underlie results in a publication

IPD Sharing Time Frame

Beginning 3 months and ending 3 years after the publication of results

IPD Sharing Access Criteria

Other researchers interested in a collaboration can contact SWENOTECA via PI Anna Grenabo Bergdahl (anna.grenabo@vgregion.se) or head of SWENOTECA Torgrim Tandstad (torgrimtandstad@gmail.com). A data sharing agreement must be signed, and documents can be submitted via e-mail to the above-mentioned contacts.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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