Therapeutic Strategy Guided by PET-TDM for Patients With Seminoma

NCT01887340 | Recruiting Phase 2

• 2 other identifiers: 2012-A01615-382012/1884
• Study Type: interventional
• Target: 271
• Locations: 1 country
• Sites: 1

Brief 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

Conditions

Seminoma

Outcome Measures

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

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

Secondary Outcomes (2)

• Rate of patients without pathological fixation

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

• Progression Free Survival (PFS)

  Assessed up to 5 years

Study Arms (2)

Cohort 1

EXPERIMENTAL

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

Drug: Carboplatin

Cohort 2

EXPERIMENTAL

* PET-TDM * ETOPOSIDE (100 mg/m2 D1 to D5) and CISPLATINE (20 mg/m2 de D1 to D5) * carboplatine: Dose (mg) = AUC x (GFR + 25) * GFR : glomérulaire filtration (ml/min) * AUC : area under curve (mg/ml x min)

Drug: Carboplatin; Drug: Etoposide; Drug: Cisplatin

Interventions

Carboplatin DRUG

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

Cohort 1; Cohort 2

Etoposide DRUG

100 mg/m2 D1 to D5

Cohort 2

Cisplatin DRUG

20 mg/m2 de D1 to D5

Cohort 2

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)
• Patient affiliated to a social security
• grade I
• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Gustave Roussy, Cancer Campus, Grand Paris: lead

Study Sites (1)

Gustave Roussy

Villejuif, Val de Marne, 94805, France

RECRUITING

Related Publications (1)

• Loriot Y, Texier M, Culine S, Flechon A, Thiery-Vuillemin A, Gravis G, Geoffrois L, Chevreau C, Gross-Goupil M, Barthelemy P, Bompas E, Mahammedi H, Laguerre B, Lacourtoisie SA, Helissey C, Ladoire S, Abraham C, Massard C, Grimaldi S, Fizazi K. The GETUG SEMITEP Trial: De-escalating Chemotherapy in Good-prognosis Seminoma Based on Fluorodeoxyglucose Positron Emission Tomography/Computed Tomography. Eur Urol. 2022 Aug;82(2):172-179. doi: 10.1016/j.eururo.2022.04.031. Epub 2022 May 20.

  PMID: 35599187 DERIVED

MeSH Terms

Conditions

Seminoma

Interventions

Carboplatin; Etoposide; Cisplatin

Condition Hierarchy (Ancestors)

Germinoma; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms

Intervention Hierarchy (Ancestors)

Coordination Complexes; Organic Chemicals; Podophyllotoxin; Tetrahydronaphthalenes; Naphthalenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Polycyclic Compounds; Glucosides; Glycosides; Carbohydrates; Chlorine Compounds; Inorganic Chemicals; Nitrogen Compounds; Platinum Compounds

Study Officials

• Yohann LORIOT, MD

  Gustave Roussy, Cancer Campus, Grand Paris

  STUDY CHAIR

Central Study Contacts

Yohann LORIOT, MD

CONTACT

0142115276; yohann.loriot@gustaveroussy.fr

Emilie LANOY

CONTACT

0142114121; emilie.lannoy@gustaveroussy.fr

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 24, 2013
• First Posted: June 26, 2013
• Study Start: June 1, 2013
• Primary Completion: June 1, 2016
• Study Completion (Estimated): June 1, 2026
• Last Updated: June 9, 2016

Record last verified: 2016-06

Locations

FR (1)