Therapeutic Strategy Guided by PET-TDM for Patients With Seminoma

Brief Title

Therapeutic Strategy Guided by PET-TDM for Patients With Seminoma

Official Title

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

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
    


Study Phase

Phase 2

Study Type

Interventional


Primary Outcome

Rate of patients without pathological fixation

Secondary Outcome

 Rate of patients without pathological fixation

Condition

Seminoma

Intervention

Carboplatin

Study Arms / Comparison Groups

 Cohort 1
Description:  PET-TDM
carboplatine: Dose (mg) = AUC x (GFR + 25)
GFR : glomérulaire filtration (ml/min)
AUC : area under curve (mg/ml x min)

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Drug

Estimated Enrollment

271

Start Date

June 2013

Completion Date

June 2026

Primary Completion Date

June 2016

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
      

Gender

Male

Ages

18 Years - N/A

Accepts Healthy Volunteers

No

Contacts

Yohann LORIOT, MD, 0142115276, [email protected]

Location Countries

France

Location Countries

France

Administrative Informations


NCT ID

NCT01887340

Organization ID

2012-A01615-38

Secondary IDs

2012/1884

Responsible Party

Sponsor

Study Sponsor

Gustave Roussy, Cancer Campus, Grand Paris


Study Sponsor

Yohann LORIOT, MD, Study Chair, Gustave Roussy, Cancer Campus, Grand Paris


Verification Date

June 2016