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Therapeutic Strategy Guided by PET-TDM for Patients With Seminoma

RECRUITINGPhase 2Sponsored by Gustave Roussy, Cancer Campus, Grand Paris
Actively Recruiting
PhasePhase 2
SponsorGustave Roussy, Cancer Campus, Grand Paris
Started2013-06
Est. completion2016-06
Eligibility
Age18 Years+
SexMALE
Healthy vol.Accepted

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

Age: 18 Years+Sex: MALEHealthy volunteers accepted
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

Conditions2

CancerSeminoma

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