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

Официальное название

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

Обзор

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?

Подробное описание

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.

Вмешательства

• Процедура primary RPLND for low-stage metasatatic seminoma
  surgical lymph node dissection
• Препарат 3 courses of chemotherapy; Blemocin, Etoposide and Platinum (BEP)
  systemic tretament for good prognosis metastastic testicular cancer

Первичные конечные точки

• HRQOL after treatment as measured by the EORTC QLQ-C30 with the testicular cancer-specific supplement EORTC QLQ-TC26 [Срок оценки: 2 years]

Вторичные конечные точки (5)

• Fatigue after RPLND vs. chemotherapy [Срок оценки: 2 years]
• Ejaculation problems [Срок оценки: 2 years]
• Treatment related complications [Срок оценки: 2 years]
• Healt economy [Срок оценки: 2 years]
• PFS [Срок оценки: 10 years]

Критерии участия

Критерии включения

• 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)

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Нерандомизированное

Модель

Параллельные группы

Маскирование

Простое слепое

Основная цель

Лечение

Центры проведения

Швеция · 1 центр

• Sahlgrenska University Hospital — Gothenburg

Публикации

• 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 Swe PMID 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. PMID 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. PMID 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. PMID 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. PMID 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 Lymphadenopath PMID 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. PMID 34388002

Идентификаторы

NCT: NCT07498959 · Dnr 2024-08434-01

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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