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Therapeutic Strategy Guided by PET-TDM for Patients With Seminoma (SEMITEP)

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ClinicalTrials.gov Identifier: NCT01887340
Recruitment Status : Recruiting
First Posted : June 26, 2013
Last Update Posted : June 9, 2016
Sponsor:
Information provided by (Responsible Party):
Gustave Roussy, Cancer Campus, Grand Paris

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

Condition or disease Intervention/treatment Phase
Seminoma Drug: Carboplatin Drug: Etoposide Drug: Cisplatin Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 271 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Official Title: Therapeutic Strategy Guided by PET-TDM for Patients With Grade I or Metastatic Seminoma
Study Start Date : June 2013
Estimated Primary Completion Date : June 2016
Estimated Study Completion Date : June 2026

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Cohort 1
  • PET-TDM
  • carboplatine: Dose (mg) = AUC x (GFR + 25)

    • GFR : glomérulaire filtration (ml/min)
    • AUC : area under curve (mg/ml x min)
Drug: Carboplatin

- carboplatine: Dose (mg) = AUC x (GFR + 25)

  • GFR : glomérulaire filtration (ml/min)
  • AUC : area under curve (mg/ml x min)

Experimental: Cohort 2
  • PET-TDM
  • ETOPOSIDE (100 mg/m2 D1 to D5) and CISPLATINE (20 mg/m2 de D1 to D5)
  • carboplatine: Dose (mg) = AUC x (GFR + 25)

    • GFR : glomérulaire filtration (ml/min)
    • AUC : area under curve (mg/ml x min)
Drug: Carboplatin

- carboplatine: Dose (mg) = AUC x (GFR + 25)

  • GFR : glomérulaire filtration (ml/min)
  • AUC : area under curve (mg/ml x min)

Drug: Etoposide
100 mg/m2 D1 to D5

Drug: Cisplatin
20 mg/m2 de D1 to D5




Primary Outcome Measures :
  1. Rate of patients without pathological fixation [ Time Frame: 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 Outcome Measures :
  1. Rate of patients without pathological fixation [ Time Frame: 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)

  2. Progression Free Survival (PFS) [ Time Frame: Assessed up to 5 years ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01887340


Contacts
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Contact: Yohann LORIOT, MD 0142115276 ext +33 yohann.loriot@gustaveroussy.fr
Contact: Emilie LANOY 0142114121 ext +33 emilie.lannoy@gustaveroussy.fr

Locations
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France
Gustave Roussy Recruiting
Villejuif, Val de Marne, France, 94805
Contact: Yohann LORIOT, MD    0142115276 ext +33    yohann.loriot@gustaveroussy.fr   
Sponsors and Collaborators
Gustave Roussy, Cancer Campus, Grand Paris
Investigators
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Study Chair: Yohann LORIOT, MD Gustave Roussy, Cancer Campus, Grand Paris

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Responsible Party: Gustave Roussy, Cancer Campus, Grand Paris
ClinicalTrials.gov Identifier: NCT01887340     History of Changes
Other Study ID Numbers: 2012-A01615-38
2012/1884 ( Other Identifier: CSET number )
First Posted: June 26, 2013    Key Record Dates
Last Update Posted: June 9, 2016
Last Verified: June 2016
Additional relevant MeSH terms:
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Seminoma
Germinoma
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms
Carboplatin
Etoposide
Etoposide phosphate
Antineoplastic Agents
Antineoplastic Agents, Phytogenic
Topoisomerase II Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action