EDEN (Etude Désescalade sEmiNome): Prospective therapeutic de-escalation and miRNA-M371 biomarker evaluation phase II study for stage IIa/IIb < 3 cm seminomas.

Authors

null

Armelle Vinceneux

Departement of Medical Oncology, Centre Léon Bérard, Lyon, France

Armelle Vinceneux , David Pasquier , Ellen Blanc , Valéry Attignon , Pierre Blanchard , Aude Flechon

Organizations

Departement of Medical Oncology, Centre Léon Bérard, Lyon, France, Academic Radiation Oncology Department, Centre Oscar Lambret, Lille, France, Department of clinical research and innovation, Centre Léon Bérard, Lyon, France, Platform of Cancer Genomics, Centre Léon Bérard, Lyon, France, Département de Radiothérapie Oncologique, Gustave Roussy, Villejuif, France, Cancérologie Médicale, Centre Léon-Bérard, Lyon Cedex, France

Research Funding

Other
PHRC-K 2020

Background: At diagnosis, 10 to 15% of testicular pure seminomas have a stage II defined by the presence of retroperitoneal lymph node metastases. The optimal choice of treatment modalities are associated with excellent efficacy but also acute and late toxicities. De-escalating treatment for seminoma patients with stage IIb, IIc and III and good prognosis according to IGCCCG (International Germ Cell Cancer Collaborative Group) based on negative FDG-PET (Fluorodeoxyglucose Positron Emission Tomography) after 2 cycles of EP (etoposide, cisplatine) chemotherapy seems feasible and safe according to SEMITEP cohort 2 results (Loriot Y, and al GETUG SEMITEP Trial: Eur Urol. 2022 Aug;82(2):172-179). Serum levels of microRNA (miR)-371a-3p (miRNA-M371) have been significantly associated with clinical stage and response to treatment in testicular germ cell tumors, with sensitivity and specificity higher than those of classic markers. The aim of the study NCT05529251 is to propose a new therapeutic approach for the stages IIa/IIb. Methods: This phase II, multicenter, prospective, randomized, non-comparative, de-escalation study will include patient with primary testicular seminomatous germ cell tumor with stage IIa/IIb < 3 cm in largest diameter seminoma, histologically proved after orchiectomy and good prognosis according to IGCCCG and LDH (Lactate DesHydogenase) < 2.5 x Upper Limit of Normal (ULN). They must have progressive disease and no prior treatment with radiotherapy or chemotherapy. In case of negative week-3 (after 1 EP cycle) PET-scan, patients will be randomized according to 2 arms ARM A: Boost of radiotherapy 20 to 30 Gray (Gy); ARM B Carboplatin AUC7 chemotherapy. In case of positive week-3 PET-scan: 3 courses of EP chemotherapy (ARM C). Primary outcome will include progression-free rate at 36 months. Secondary Outcome Measures will be serum level of miRNA M371, correlation with response to treatments and PET scan results, overall survival (OS), quality of life and tolerance to treatment. Blood samples (miRNA-M371) will be collected at screening, at the time of randomization before second cycle of chemotherapy or radiotherapy, at the end of treatment and at relapse. Enrollment has started in October 2022. A total of 90 patients will be included in the interventional study, leading to approximately 60 patients with negative FDG-PET randomized. Clinical trial information: NCT05529251.

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Abstract Details

Meeting

2023 ASCO Genitourinary Cancers Symposium

Session Type

Trials in Progress Poster Session

Session Title

Trials in Progress Poster Session C: Renal Cell Cancer; Adrenal, Penile, Urethral, and Testicular Cancers

Track

Renal Cell Cancer,Adrenal Cancer,Penile Cancer,Testicular Cancer,Urethral Cancer

Sub Track

Therapeutics

Clinical Trial Registration Number

NCT05529251

Citation

J Clin Oncol 41, 2023 (suppl 6; abstr TPS434)

DOI

10.1200/JCO.2023.41.6_suppl.TPS434

Abstract #

TPS434

Poster Bd #

N16

Abstract Disclosures