Clinical trial · Interventional
Therapeutic Strategy Guided by PET-TDM for Patients With Seminoma
Therapeutic Strategy Guided by PET-TDM for Patients With Grade I or Metastatic Seminoma
NCT01887340CI-TRIAL-00022526SEMITEPunknownPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Seminoma | Seminoma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Carboplatin | Drug | Carboplatin | ALIAS |
| Cisplatin | Drug | Cisplatin | ALIAS |
| Etoposide | Drug | Etoposide | ALIAS |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- 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)
- interventionNames
- Drug: Carboplatin
- type
- EXPERIMENTAL
- label
- Cohort 2
- description
- * 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)
- interventionNames
- Drug: Carboplatin
- Drug: Etoposide
- Drug: Cisplatin
Primary outcomes (1)
- measure
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (1)
- DERIVEDLoriot 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. PMID 35599187