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?
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
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
160
surgical lymph node dissection
systemic tretament for good prognosis metastastic testicular cancer
Sahlgrenska University Hospital
Gothenburg, Göteborg, Sweden
RECRUITINGHRQOL 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.
Time frame: 2 years
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).
Time frame: 2 years
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).
Time frame: 2 years
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.
Time frame: 2 years
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.
Time frame: 2 years
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).
Time frame: 10 years
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