Therapeutic Strategy Guided by PET-TDM for Patients With Seminoma
Therapeutic Strategy Guided by PET-TDM for Patients With Grade I or Metastatic Seminoma
Gustave Roussy, Cancer Campus, Grand Paris
271 participants
Jun 1, 2013
INTERVENTIONAL
Conditions
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
Eligibility
Inclusion Criteria16
- 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
- grade I
- 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 Criteria9
- 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
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Interventions
\- carboplatine: Dose (mg) = AUC x (GFR + 25) * GFR : glomérulaire filtration (ml/min) * AUC : area under curve (mg/ml x min)
100 mg/m2 D1 to D5
20 mg/m2 de D1 to D5
Locations(1)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT01887340