The GETUG SEMITEP Trial: De-escalating Chemotherapy in Good-prognosis Seminoma Based on Fluorodeoxyglucose Positron Emission Tomography/Computed Tomography.
Yohann Loriot, Matthieu Texier, Stéphane Culine...
https://pubmed.ncbi.nlm.nih.gov/35599187Actively Recruiting
Phase 2
Age: 18Years +
MALE
ID01887340
Therapeutic Strategy Guided by PET-TDM for Patients With Grade I or Metastatic Seminoma
Led by Gustave Roussy, Cancer Campus, Grand Paris · Updated on 2016-06-09
271
Participants Needed
1
Research Sites
521 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating a therapeutic strategy guided by 18F-fluoro-deoxyglucose positron emission tomography (PET-TDM) for patients with grade I or metastatic seminoma. The study aims to determine the proportion of patients who can receive a lighter treatment approach based on PET-TDM results. This phase 2 trial focuses on patients with seminoma, a type of testicular cancer, and assesses outcomes such as pathological fixation rate and progression-free survival. Participants are assigned to one of two groups: cohort 1 includes patients with grade I seminoma, and cohort 2 includes patients with metastatic seminoma of specific grades (IIB, IIC, or III) and positive PET-TDM results. Treatments involve carboplatin dosed according to kidney function and area under the curve (AUC). Cohort 2 also receives etoposide and cisplatin over five days. The study uses PET-TDM to guide the therapeutic approach, adjusting treatments based on imaging findings. During the study, patients undergo PET-TDM scans and receive chemotherapy as assigned. Researchers measure the rate of patients without pathological fixation at inclusion or after two chemotherapy cycles, within 21 days. Long-term follow-up includes progression-free survival monitored for up to five years. Safety and treatment response are assessed regularly to understand treatment effects and outcomes over time.
CONDITIONS
Brief Title
Therapeutic Strategy Guided by PET-TDM for Patients With Seminoma
Who Can Participate
Age: 18Years +
MALE
Eligibility Criteria
You may qualify if you...
- Histologically proven seminoma after orchiectomy
- Primary testicular or retroperitoneal seminoma
- Normal alpha-fetoprotein before and after orchiectomy
- No prior radiotherapy or chemotherapy
- Age 18 years or older
- ECOG performance status 0 to 2
- Neutrophils (PNN) at least 1500
- Platelets at least 100,000
- Bilirubin within normal limits
- ASAT (SGOT) and ALAT (SGPT) less than or equal to 1.5 times normal limit
- Serum creatinine less than 140 µmol/L or clearance greater than 60 mL/min
- Signed informed consent
- Affiliated to social security
- For cohort 1: grade I seminoma
- For cohort 2: grade IIB (adenopathy 2-5 cm), grade IIC (adenopathy >5 cm), or grade III with good prognosis and positive PET-TDM
You will not qualify if you...
- Infection with HIV, Hepatitis B, or Hepatitis C
- History of cancer other than seminoma within 5 years, except treated basal cell skin cancer
- Visceral metastasis
- Brain metastasis
- Any physical or mental condition incompatible with treatment
- Uncontrolled or severe cardiovascular disease
- Uncontrolled or severe liver disease
- Persons deprived of liberty or under guardianship
- Unable to undergo medical monitoring due to geographic, social, or psychological reasons
AI-Screening
AI-Powered Screening
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Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Treatment
Duration - Up to 2 cycles of chemotherapy, up to 21 days
Participants receive chemotherapy with carboplatin alone or combined with etoposide and cisplatin depending on cohort assignment.
Multiple visits during chemotherapy cycles
Follow-up
Duration - Up to 5 years
Participants are monitored for progression-free survival and long-term outcomes after treatment.
Trial Site Locations
Total: 1 location
1
Gustave Roussy
Villejuif, Val de Marne, France, 94805
Actively Recruiting
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Research Team
Y
Yohann LORIOT, MD
E
Emilie LANOY
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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