Therapeutic Strategy Guided by PET-TDM for Patients With Seminoma (SEMITEP)

Therapeutic Strategy Guided by PET-TDM for Patients With Grade I or Metastatic Seminoma

The purpose of the study is to evaluate the ration of patients getting an lighten therapeutic strategy after 18F-fluoro-désoxyglucose positron emission tomography (PET-TDM) in grade I (cohort 1) or metastatic (cohort 2) seminoma

Study Overview

• Status: Recruiting
• Conditions: Seminoma
• Intervention / Treatment: Drug: Carboplatin; Drug: Etoposide; Drug: Cisplatin

• Study Type: Interventional
• Enrollment (Anticipated): 271
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: Yohann LORIOT, MD; Phone Number: +33 0142115276; Email: yohann.loriot@gustaveroussy.fr
• Study Contact Backup: Name: Emilie LANOY; Phone Number: +33 0142114121; Email: emilie.lannoy@gustaveroussy.fr

Study Locations

• France
  • Val de Marne
    • Villejuif, Val de Marne, France, 94805
      • Recruiting
      • Gustave Roussy
      • Contact: Yohann LORIOT, MD; Phone Number: +33 0142115276; Email: yohann.loriot@gustaveroussy.fr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Male

Description

Inclusion Criteria shared:

• Histologically proved seminoma after orchiectomy
• Primary testicular or retroperitoneal
• Normal alpha-fetoprotein before and after orchiectomy
• No prior treatment with radiotherapy or chemotherapy
• Age >= 18 years
• ECOG 0 to 2
• PNN >= 1500, platelets >= 100 000, bilirubin <= the upper limit nromale
• ASAT (SGOT) and ALAT (SGPT) <= 1,5 x the upper limit nromale
• Serum creatinine <140 µmol / L (or clearance> 60 mL / min)
• Information and signed informed consent before inclusion in the study
• Patient affiliated to a social security

Specific inclusion criteria for cohort 1:

• grade I

Specific inclusion criteria for cohort 2:

• grade IIB (retroperitoneal adenopathy diameter between 2 cm and 5 cm, regardless of the LDH)
• grade IIC (retroperitoneal adenopathy diameter higher than 5 cm, regardless of the LDH)
• grade III of good prognosis (supradiaphragmatic reach with ganglionic metastasis and LDH < 2 times normal limit and/or supradiaphragmatic reach with pulmonary metastasis and LDH < 2 times normal limit) either at initial diagnosis or relapse of a grade I seminoma)
• PET-TDM positive (pathological fixation on metastatic lesions)

Exclusion Criteria shared:

• Patient infected by HIV, Hepatitis B or C
• History, within 5 years, of cancer other than seminoma, except for treated skin cancer (Basal Cell) .
• visceral metastasis
• cerebral metastasis
• Any physical or mental condition incompatible with the treatment (to the investigator discretion)
• Uncontrolled or severe cardiovascular pathology
• Uncontrolled or severe hepatic pathology
• Persons deprived of liberty or under guardianship
• Unable to undergo medical monitoring due to geographical, social or psychological reasons

Study Plan

How is the study designed?

Design Details

• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Cohort 1; PET-TDM; carboplatine: Dose (mg) = AUC x (GFR + 25)GFR : glomérulaire filtration (ml/min)AUC : area under curve (mg/ml x min)	Drug: Carboplatin; - carboplatine: Dose (mg) = AUC x (GFR + 25); GFR : glomérulaire filtration (ml/min); AUC : area under curve (mg/ml x min)
Experimental: Cohort 2; PET-TDM; ETOPOSIDE (100 mg/m2 D1 to D5) and CISPLATINE (20 mg/m2 de D1 to D5); carboplatine: Dose (mg) = AUC x (GFR + 25)GFR : glomérulaire filtration (ml/min)AUC : area under curve (mg/ml x min)	Drug: Carboplatin; - carboplatine: Dose (mg) = AUC x (GFR + 25); GFR : glomérulaire filtration (ml/min); AUC : area under curve (mg/ml x min); Drug: Etoposide; 100 mg/m2 D1 to D5; Drug: Cisplatin; 20 mg/m2 de D1 to D5

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Rate of patients without pathological fixation	Rate of patients without pathological fixation at the time of the inclusion PET-TDM (cohort 1) or at the time of the PET-TDM following two cycles of chemotherapy (Etoposiede+Cisplatine) (cohort 2) and getting a lighten protocol	Assessed at the time of inclusion or after 2 cycles of chemotherapy, up to 21 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Rate of patients without pathological fixation	Rate of patients without pathological fixation at the time of the inclusion PET-TDM (cohort 1) or at the time of the PET-TDM following two cycles of chemotherapy (Etoposiede+Cisplatine) (cohort 2)	Assessed at the time of inclusion or after 2 cycles of chemotherapy, up to 21 days
Progression Free Survival (PFS)		Assessed up to 5 years

Collaborators and Investigators

• Sponsor: Gustave Roussy, Cancer Campus, Grand Paris
• Investigators: Study Chair: Yohann LORIOT, MD, Gustave Roussy, Cancer Campus, Grand Paris

Publications and helpful links

General Publications

• Loriot Y, Texier M, Culine S, Flechon A, Thiery-Vuillemin A, Gravis G, Geoffrois L, Chevreau C, Gross-Goupil M, Barthelemy P, Bompas E, Mahammedi H, Laguerre B, Lacourtoisie SA, Helissey C, Ladoire S, Abraham C, Massard C, Grimaldi S, Fizazi K. The GETUG SEMITEP Trial: De-escalating Chemotherapy in Good-prognosis Seminoma Based on Fluorodeoxyglucose Positron Emission Tomography/Computed Tomography. Eur Urol. 2022 Aug;82(2):172-179. doi: 10.1016/j.eururo.2022.04.031. Epub 2022 May 20.

Study record dates

Study Major Dates

• Study Start: June 1, 2013
• Primary Completion (Anticipated): June 1, 2016
• Study Completion (Anticipated): June 1, 2026

Study Registration Dates

• First Submitted: June 24, 2013
• First Submitted That Met QC Criteria: June 24, 2013
• First Posted (Estimate): June 26, 2013

Study Record Updates

• Last Update Posted (Estimate): June 9, 2016
• Last Update Submitted That Met QC Criteria: June 8, 2016
• Last Verified: June 1, 2016

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms by Histologic Type; Neoplasms; Neoplasms, Germ Cell and Embryonal; Germinoma; Seminoma; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Antineoplastic Agents; Antineoplastic Agents, Phytogenic; Topoisomerase II Inhibitors; Topoisomerase Inhibitors; Carboplatin; Etoposide
• Other Study ID Numbers: 2012-A01615-38; 2012/1884 (Other Identifier: CSET number)