CONSERVATIVE MANAGEMENT OF ENDOMETRIAL CANCER AND ATYPICAL HYPERPLASIA - ND
- Conditions
- MedDRA version: 9.1Level: LLTClassification code 10007063
- Registration Number
- EUCTR2010-018581-23-IT
- Lead Sponsor
- ISTITUTO NAZIONALE PER LO STUDIO E LA CURA DEI TUMORI - FONDAZIONE G. PASCALE
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Authorised-recruitment may be ongoing or finished
- Sex
- Female
- Target Recruitment
- Not specified
Inclusion Criteria
? age ≤ 40 years
? BMI ≤ 36
? P.S. WHO scale 0-1
? diagnosis of well differentiated stage IA (intramucous) EEC or EAI
? ER/PR positive
? normal serum levels of CA125 (< 35 IU/ml)
? informed consent to conservative management
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range
Exclusion Criteria
? multifocal endometrial cancer
? concomitant cancers except for properly treated cutaneous basocellular carcinoma and in situ cervical carcinoma.
? HPNCC-Lynch II syndrome
? controindications for LNG-IUD insertion
? AIDS
? acute and chronic liver diseases
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: Evaluation of efficacy and safety profile of combined conservative treatment in women aged ≤ 40 years with well differentiated stage IA (intramucous) EEC or EAI using operative HSC and LNG-IUD;Secondary Objective: spontaneous pregnancy rate <br>- assisted reproduction technology (ART) pregnancy rate;Primary end point(s): recurrence-free rate, morbidity
- Secondary Outcome Measures
Name Time Method