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Therapeutic Strategy Guided by PET-TDM for Patients With Seminoma

ConditionSeminoma
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexMale
Age18+
SponsorGustave Roussy, Cancer Campus, Grand Paris

About this trial

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

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Histologically proved seminoma after orchiectomy

Primary testicular or retroperitoneal

Normal alpha-fetoprotein before and after orchiectomy

No prior treatment with radiotherapy or chemotherapy

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • Carboplatin

    Drug

    \- carboplatine: Dose (mg) = AUC x (GFR + 25) * GFR : glomérulaire filtration (ml/min) * AUC : area under curve (mg/ml x min)

  • Etoposide

    Drug

    100 mg/m2 D1 to D5

  • Cisplatin

    Drug

    20 mg/m2 de D1 to D5

Treatment groups

271 Participants
are divided into 2 treatment groups
Group A: Cohort 1Experimental treatment 1 intervention
Group B: Cohort 2Experimental treatment 3 interventions

Trial outcomes

Primary outcomes

1

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

Time frame
Assessed at the time of inclusion or after 2 cycles of chemotherapy, up to 21 days

Secondary outcomes

1

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)

Time frame
Assessed at the time of inclusion or after 2 cycles of chemotherapy, up to 21 days
2

Progression Free Survival (PFS)

Time frame
Assessed up to 5 years

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Gustave Roussy, Cancer Campus, Grand Paris

Lead sponsor

Source ClinicalTrials.gov
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