Actively Recruiting
Therapeutic Strategy Guided by PET-TDM for Patients With Seminoma
Led by Gustave Roussy, Cancer Campus, Grand Paris · Updated on 2016-06-09
271
Participants Needed
1
Research Sites
678 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
Official Title
Therapeutic Strategy Guided by PET-TDM for Patients With Seminoma
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Histologically confirmed seminoma after orchiectomy
- Primary testicular or retroperitoneal seminoma
- Normal alpha-fetoprotein levels before and after orchiectomy
- No prior chemotherapy or radiotherapy treatment
- Age 18 years or older
- ECOG performance status 0 to 2
- Neutrophil count (PNN) at least 1500
- Platelet count at least 100,000
- Bilirubin levels within normal limits
- ASAT (SGOT) and ALAT (SGPT) not exceeding 1.5 times the upper normal limit
- Serum creatinine less than 140 �b5mol/L or creatinine clearance over 60 mL/min
- Provided informed consent before joining the study
- Affiliated with social security
- Cohort 1 specific: Grade I seminoma
- Cohort 2 specific: Grade IIB or IIC retroperitoneal adenopathy, or grade III with good prognosis including certain metastatic conditions and PET-TDM positive lesions
You will not qualify if you...
- Infection with HIV, Hepatitis B, or Hepatitis C
- History of cancer other than seminoma within the past 5 years, except treated basal cell skin cancer
- Presence of visceral metastasis
- Presence of brain metastasis
- Any physical or mental condition that prevents treatment as judged by the investigator
- Uncontrolled or severe heart disease
- Uncontrolled or severe liver disease
- Being under legal guardianship or deprived of liberty
- Inability to attend medical monitoring due to geographic, social, or psychological reasons
AI-Screening
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Trial Site Locations
Total: 1 location
1
Gustave Roussy
Villejuif, Val de Marne, France, 94805
Actively Recruiting
Research Team
Y
Yohann LORIOT, MD
CONTACT
E
Emilie LANOY
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
PARALLEL
Primary Purpose
N/A
Number of Arms
2
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