Therapeutic Strategy Guided by PET-TDM for Patients With Seminoma
NCT ID: NCT01887340
Last Updated: 2016-06-09
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE2
271 participants
INTERVENTIONAL
2013-06-30
2026-06-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
NONE
Study Groups
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Cohort 1
* PET-TDM
* carboplatine: Dose (mg) = AUC x (GFR + 25)
* GFR : glomérulaire filtration (ml/min)
* AUC : area under curve (mg/ml x min)
Carboplatin
\- carboplatine: Dose (mg) = AUC x (GFR + 25)
* GFR : glomérulaire filtration (ml/min)
* AUC : area under curve (mg/ml x min)
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)
Carboplatin
\- carboplatine: Dose (mg) = AUC x (GFR + 25)
* GFR : glomérulaire filtration (ml/min)
* AUC : area under curve (mg/ml x min)
Etoposide
100 mg/m2 D1 to D5
Cisplatin
20 mg/m2 de D1 to D5
Interventions
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Carboplatin
\- carboplatine: Dose (mg) = AUC x (GFR + 25)
* GFR : glomérulaire filtration (ml/min)
* AUC : area under curve (mg/ml x min)
Etoposide
100 mg/m2 D1 to D5
Cisplatin
20 mg/m2 de D1 to D5
Eligibility Criteria
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Inclusion Criteria
* 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 Criteria
* 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
18 Years
MALE
No
Sponsors
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Gustave Roussy, Cancer Campus, Grand Paris
OTHER
Responsible Party
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Principal Investigators
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Yohann LORIOT, MD
Role: STUDY_CHAIR
Gustave Roussy, Cancer Campus, Grand Paris
Locations
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Gustave Roussy
Villejuif, Val de Marne, France
Countries
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Central Contacts
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Facility Contacts
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References
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Loriot Y, Texier M, Culine S, Flechon A, Thiery-Vuillemin A, Gravis G, Geoffrois L, Chevreau C, Gross-Goupil M, Barthelemy P, Bompas E, Mahammedi H, Laguerre B, Lacourtoisie SA, Helissey C, Ladoire S, Abraham C, Massard C, Grimaldi S, Fizazi K. The GETUG SEMITEP Trial: De-escalating Chemotherapy in Good-prognosis Seminoma Based on Fluorodeoxyglucose Positron Emission Tomography/Computed Tomography. Eur Urol. 2022 Aug;82(2):172-179. doi: 10.1016/j.eururo.2022.04.031. Epub 2022 May 20.
Other Identifiers
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2012/1884
Identifier Type: OTHER
Identifier Source: secondary_id
2012-A01615-38
Identifier Type: -
Identifier Source: org_study_id
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