Overview

Therapeutic Strategy Guided by PET-TDM for Patients With Seminoma

Status:
Recruiting
Trial end date:
2026-06-01
Target enrollment:
0
Participant gender:
Male
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
Phase:
Phase 2
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Gustave Roussy, Cancer Campus, Grand Paris
Treatments:
Carboplatin
Etoposide
Etoposide phosphate
Criteria
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