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| Name | Class |
|---|---|
| Karolinska University Hospital | OTHER |
| Haukeland University Hospital | OTHER |
| University Hospital of North Norway | OTHER |
| Oslo University Hospital |
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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:
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:
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:
Differences in fatigue across study-groups as measured by the Fatigue Questionnaire (FQ).
Differences across study-groups in patient-reported prevalence of retrograde ejaculation as assessed by supplementary questions.
Rate of doctor-reported complications related to treatment in the study-groups.
Differences in quality-adjusted life years across study-groups as measured by the EQ-5D-5L tool
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Surgery group | Active Comparator | Undergoing primary RPLND |
|
| Chemotherapy group | Active Comparator | Receiving chemotherapy |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| primary RPLND for low-stage metasatatic seminoma | Procedure | surgical lymph node dissection |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 2 years |
| Measure | Description | Time Frame |
|---|---|---|
| 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). |
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Inclusion Criteria:
Exclusion Criteria:
male
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Sahlgrenska University Hospital | Recruiting | Gothenburg | Göteborg | 413 45 | Sweden |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38966804 | Background | 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. | |
| 36372627 |
| Label | URL |
|---|---|
| Swedish and Norwegian Testicular Cancer Group | View source |
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all IPD that underlie results in a publication
Beginning 3 months and ending 3 years after the publication of results
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.
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| OTHER |
| Trondheim University Hospital | OTHER |
| Uppsala University Hospital | OTHER |
| University Hospital, Umeå | OTHER |
| Lund University Hospital | OTHER |
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| 3 courses of chemotherapy; Blemocin, Etoposide and Platinum (BEP) | Drug | systemic tretament for good prognosis metastastic testicular cancer |
|
|
| 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). | 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. | 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. | 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). | 10 years |
| Background |
| 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. |
| 37672753 | Background | 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. |
| 37438222 | Background | 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. |
| 35950045 | Background | 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. |
| 36913642 | Background | 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. |
| 34388002 | Background | 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. |
| ID | Term |
|---|---|
| D013736 | Testicular Neoplasms |
| D018239 | Seminoma |
| ID | Term |
|---|---|
| D004701 | Endocrine Gland Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D005834 | Genital Neoplasms, Male |
| D014565 | Urogenital Neoplasms |
| D005832 | Genital Diseases, Male |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D004700 | Endocrine System Diseases |
| D013733 | Testicular Diseases |
| D006058 | Gonadal Disorders |
| D018237 | Germinoma |
| D009373 | Neoplasms, Germ Cell and Embryonal |
| D009370 | Neoplasms by Histologic Type |
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| ID | Term |
|---|---|
| D005047 | Etoposide |
| D010984 | Platinum |
| D020360 | Neoadjuvant Therapy |
| D001761 | Bleomycin |
| ID | Term |
|---|---|
| D011034 | Podophyllotoxin |
| D013764 | Tetrahydronaphthalenes |
| D009281 | Naphthalenes |
| D011084 | Polycyclic Aromatic Hydrocarbons |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D011083 | Polycyclic Compounds |
| D005960 | Glucosides |
| D006027 | Glycosides |
| D002241 | Carbohydrates |
| D019216 | Metals, Heavy |
| D004602 | Elements |
| D007287 | Inorganic Chemicals |
| D028561 | Transition Elements |
| D008670 | Metals |
| D003131 | Combined Modality Therapy |
| D013812 | Therapeutics |
| D006020 | Glycopeptides |
| D006001 | Glycoconjugates |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |
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