Therapeutic Strategy Guided by PET-TDM for Patients With Seminoma

Seminoma Clinical Trial

— SEMITEP  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01887340
• Other study ID #: 2012-A01615-38
• Secondary ID: 2012/1884
• Status: Recruiting
• Phase: Phase 2
• First received: June 24, 2013
• Last updated: June 8, 2016
• Start date: June 2013
• Est. completion date: June 2026

Study information

• Verified date: June 2016
• Source: Gustave Roussy, Cancer Campus, Grand Paris
• Contact: Yohann LORIOT, MD
• Phone: 0142115276
• Email: yohann.loriot[@]gustaveroussy.fr
• Is FDA regulated: No
• Health authority: France: Agence Nationale de Sécurité du Médicament et des produits de santé
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 271
• Est. completion date: June 2026
• Est. primary completion date: June 2016
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Non-Randomized, Intervention Model: Parallel Assignment, Masking: Open Label

Related Conditions & MeSH terms

• Seminoma

Intervention

Drug:
• 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

Locations

Country	Name	City	State
France	Gustave Roussy	Villejuif	Val de Marne

Sponsors (1)

Lead Sponsor	Collaborator
Gustave Roussy, Cancer Campus, Grand Paris

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Rate of patients without pathological fixation	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	Assessed at the time of inclusion or after 2 cycles of chemotherapy, up to 21 days	No
Secondary	Rate of patients without pathological fixation	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)	Assessed at the time of inclusion or after 2 cycles of chemotherapy, up to 21 days	No
Secondary	Progression Free Survival (PFS)		Assessed up to 5 years	No