Clinical trial NCT01887340: 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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE2
Conditions: Seminoma
Lead sponsor: Gustave Roussy, Cancer Campus, Grand Paris
Sponsor class: OTHER
First posted: 2013-06-26
Enrollment: 271
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL

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


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

Primary outcomes:
measure: Rate of patients without pathological fixation
timeFrame: Assessed at the time of inclusion or after 2 cycles of chemotherapy, up to 21 days
Secondary outcomes:
measure: Rate of patients without pathological fixation
timeFrame: Assessed at the time of inclusion or after 2 cycles of chemotherapy, up to 21 days
measure: Progression Free Survival (PFS)
timeFrame: Assessed up to 5 years
Other outcomes:
Locations:
city: Villejuif
country: France
facility: Gustave Roussy
state: Val de Marne
Study officials:
affiliation: Gustave Roussy, Cancer Campus, Grand Paris
name: Yohann LORIOT, MD
role: STUDY_CHAIR
References:
citation: 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.