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De-escalation Study for Stage IIa/IIb < 3 cm Seminoma
Sponsor: Centre Leon Berard
Summary
Phase II, multicenter, prospective, randomized, non-comparative, de-escalation study. Patients with stage IIa/IIb \< 3 cm seminoma histologically proved after orchiectomy will be included in the study and will receive 1 cycle of Etoposide Cisplatine (EP) chemotherapy. Patients with negative week-3 PET-scan after the EP cycle, will be randomized (1:1 ratio, stratification according to the disease stage (stage IIa versus IIb seminoma)) to receive either radiotherapy (RT) boost on lymph nodes or 1 cycle of carboplatin AUC7 chemotherapy. Patients with positive week-3 PET-scan will received 3 additional cycles of EP chemotherapy. In parallel, eligible patients scheduled to receive standard lombo-aortic RT will be registered in an observational cohort.
Official title: Prospective Therapeutic De-escalation and miRNA-M371 Biomarker Evaluation Phase II Study for Stage IIa/IIb < 3 cm Seminomas
Key Details
Gender
MALE
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
90
Start Date
2022-09-06
Completion Date
2030-09-06
Last Updated
2024-01-25
Healthy Volunteers
No
Interventions
Radiotherapy boost
Radiotherapy boost 20 to 30 Gy, in daily 2 Gy fractions and 5 fractions per week : * 20 Gy if no more disease is visible (node \< 1 cm in large diameter) * 24 Gy for nodes \<= 2 cm * 30 Gy for nodes \> 2 cm
Carboplatin AUC7
Carboplatin at dose (mg) = AUC7 (mg/ml x min) x (DFG ml/min + 25)
3 cycles of EP
3 Cycles of EP chemotherapy, administred every 3 weeks following standard practice
Locations (15)
CHU Besançon
Besançon, France
CHU Bordeaux
Bordeaux, France
Centre François Baclesse
Caen, France
Centre Jean Perrin
Clermont-Ferrand, France
Centre Oscar Lambret
Lille, France
CHU de Limoges
Limoges, France
Centre Leon Bérard
Lyon, France
Institut Paoli Calmettes
Marseille, France
Centre Antoine Lacassagne
Nice, France
Hôpital Saint Louis
Paris, France
ICO René Gauducheau
Saint-Herblain, France
Hôpital Foch
Suresnes, France
Institut Universitaire de Cancer de Toulouse (IUCT-O)
Toulouse, France
Institut de Cancérologie de Lorraine
Vandœuvre-lès-Nancy, France
Institut Gustave Roussy
Villejuif, France