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Therapeutic Strategy Guided by PET-TDM for Patients With Seminoma

Therapeutic Strategy Guided by PET-TDM for Patients With Seminoma

Recruiting
18 years and older
Male
Phase 2

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Overview

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 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

Study details
    Seminoma

NCT01887340

Gustave Roussy, Cancer Campus, Grand Paris

15 May 2026

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