De-escalation, Quality of Life, RPLND, Seminoma, Testicular Cancer
Conditions
Keywords
testicular cancer, seminoma, primary RPLND
Brief 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 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?
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.
Interventions
PROCEDUREprimary RPLND for low-stage metasatatic seminoma
surgical lymph node dissection
DRUG3 courses of chemotherapy; Blemocin, Etoposide and Platinum (BEP)
systemic tretament for good prognosis metastastic testicular cancer
Sponsors
Sahlgrenska University Hospital
Karolinska University Hospital
Haukeland University Hospital
University Hospital of North Norway
Oslo University Hospital
Trondheim University Hospital
Uppsala University Hospital
Norrlands Universitetssjukhus, Umea, Sweden
Lund University Hospital
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
MALE
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| HRQOL after treatment as measured by the EORTC QLQ-C30 with the testicular cancer-specific supplement EORTC QLQ-TC26 | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Fatigue after RPLND vs. chemotherapy | 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). |
| Ejaculation problems | 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). |
| Treatment related complications | 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. |
| Healt economy | 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. |
| PFS | 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). |
Countries
Sweden
Outcome results
None listed