Seminoma
Conditions
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
Interventions
DRUGCarboplatin
\- carboplatine: Dose (mg) = AUC x (GFR + 25) * GFR : glomérulaire filtration (ml/min) * AUC : area under curve (mg/ml x min)
DRUGEtoposide
100 mg/m2 D1 to D5
DRUGCisplatin
20 mg/m2 de D1 to D5
Sponsors
Gustave Roussy, Cancer Campus, Grand Paris
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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) |
| Progression Free Survival (PFS) | Assessed up to 5 years | — |
Countries
France
Contacts
Primary ContactYohann LORIOT, MD
Backup ContactEmilie LANOY
Outcome results
None listed