Therapeutic Strategy Guided by PET-TDM for Patients With Seminoma

Study Overview
=================
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

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

Conditions
-----------------
Seminoma

Intervention / Treatment
-----------------
* Drug: Carboplatin
* Drug: Etoposide
* Drug: Cisplatin


Participation Criteria
=================
Eligibility Criteria
-----------------
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
Male

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

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


Arms and Interventions

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

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 |