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Therapeutic Strategy Guided by PET-TDM for Patients With Grade I or Metastatic Seminoma


Phase 2
18 Years
N/A
Open (Enrolling)
Male
Seminoma

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Trial Information

Therapeutic Strategy Guided by PET-TDM for Patients With Grade I or Metastatic Seminoma

Inclusion 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

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Intervention Model: Parallel Assignment, Masking: Open Label

Outcome Measure:

Rate of patients without pathological fixation

Outcome Description:

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

Outcome Time Frame:

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

Safety Issue:

No

Principal Investigator

Yohann LORIOT, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Gustave Roussy, Cancer Campus, Grand Paris

Authority:

France: Agence Nationale de Sécurité du Médicament et des produits de santé

Study ID:

2012-A01615-38

NCT ID:

NCT01887340

Start Date:

June 2013

Completion Date:

June 2026

Related Keywords:

  • Seminoma
  • Seminoma

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