Actively Recruiting

Phase 2
Age: 18Years +
MALE
NCT01887340

Therapeutic Strategy Guided by PET-TDM for Patients With Seminoma

Led by Gustave Roussy, Cancer Campus, Grand Paris · Updated on 2016-06-09

271

Participants Needed

1

Research Sites

678 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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

Official Title

Therapeutic Strategy Guided by PET-TDM for Patients With Seminoma

Who Can Participate

Age: 18Years +
MALE

Eligibility Criteria

Eligible

You may qualify if you...

  • Histologically confirmed seminoma after orchiectomy
  • Primary testicular or retroperitoneal seminoma
  • Normal alpha-fetoprotein levels before and after orchiectomy
  • No prior chemotherapy or radiotherapy treatment
  • Age 18 years or older
  • ECOG performance status 0 to 2
  • Neutrophil count (PNN) at least 1500
  • Platelet count at least 100,000
  • Bilirubin levels within normal limits
  • ASAT (SGOT) and ALAT (SGPT) not exceeding 1.5 times the upper normal limit
  • Serum creatinine less than 140 �b5mol/L or creatinine clearance over 60 mL/min
  • Provided informed consent before joining the study
  • Affiliated with social security
  • Cohort 1 specific: Grade I seminoma
  • Cohort 2 specific: Grade IIB or IIC retroperitoneal adenopathy, or grade III with good prognosis including certain metastatic conditions and PET-TDM positive lesions
Not Eligible

You will not qualify if you...

  • Infection with HIV, Hepatitis B, or Hepatitis C
  • History of cancer other than seminoma within the past 5 years, except treated basal cell skin cancer
  • Presence of visceral metastasis
  • Presence of brain metastasis
  • Any physical or mental condition that prevents treatment as judged by the investigator
  • Uncontrolled or severe heart disease
  • Uncontrolled or severe liver disease
  • Being under legal guardianship or deprived of liberty
  • Inability to attend medical monitoring due to geographic, social, or psychological reasons

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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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

CONTACT

E

Emilie LANOY

CONTACT

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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Therapeutic Strategy Guided by PET-TDM for Patients With Seminoma | DecenTrialz