Therapeutic Strategy Guided by PET-TDM for Patients With Seminoma

Phase 2

Recruiting

• Conditions: Seminoma
• Interventions: Drug: Carboplatin; Drug: Etoposide; Drug: Cisplatin

• Registration Number: NCT01887340
• Lead Sponsor: Gustave Roussy, Cancer Campus, Grand Paris

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2013-06
• Study First Submitted: 2013-06-24
• Study First Submitted QC: 2013-06-24
• Study First Posted: 2013-06-26
• Status Verified: 2016-06
• Primary Completion: 2016-06
• Last Update Submitted: 2016-06-08
• Last Update Posted: 2016-06-09
• Study Completion: 2026-06

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Male
• Target Recruitment: 271

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Cohort 2	Carboplatin	* 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)
Cohort 1	Carboplatin	* PET-TDM * carboplatine: Dose (mg) = AUC x (GFR + 25) * GFR : glomérulaire filtration (ml/min) * AUC : area under curve (mg/ml x min)
Cohort 2	Etoposide	* 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)
Cohort 2	Cisplatin	* 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)

Primary Outcome Measures

Name	Time	Method
Rate of patients without pathological fixation	Assessed at the time of inclusion or after 2 cycles of chemotherapy, up to 21 days	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

Secondary Outcome Measures

Name	Time	Method
Progression Free Survival (PFS)	Assessed up to 5 years
Rate of patients without pathological fixation	Assessed at the time of inclusion or after 2 cycles of chemotherapy, up to 21 days	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)

Trial Locations

Locations (1)

Gustave Roussy; 🇫🇷 Villejuif, Val de Marne, France