Status:
RECRUITING
Therapeutic Strategy Guided by PET-TDM for Patients With Seminoma
Lead Sponsor:
Gustave Roussy, Cancer Campus, Grand Paris
Conditions:
Seminoma
Eligibility:
MALE
18+ years
Phase:
PHASE2
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 me...
Eligibility Criteria
Inclusion
- 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
Exclusion
Key Trial Info
Start Date :
June 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 1 2026
Estimated Enrollment :
271 Patients enrolled
Trial Details
Trial ID
NCT01887340
Start Date
June 1 2013
End Date
June 1 2026
Last Update
June 9 2016
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Gustave Roussy
Villejuif, Val de Marne, France, 94805