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RECRUITING
NCT05529251
PHASE2

De-escalation Study for Stage IIa/IIb < 3 cm Seminoma

Sponsor: Centre Leon Berard

View on ClinicalTrials.gov

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

RADIATION

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

DRUG

Carboplatin AUC7

Carboplatin at dose (mg) = AUC7 (mg/ml x min) x (DFG ml/min + 25)

DRUG

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