Exemestane in Advanced and Recurrent Endometrial Carcinoma
- Registration Number
- NCT01965080
- Lead Sponsor
- Nordic Society of Gynaecological Oncology - Clinical Trials Unit
- Brief Summary
A phase II study of Exemestane in Advanced or recurrent endometrial carcinoma
Hypothesis: Treatment With Exemestane can give a response rate of at least 30%
- Detailed Description
Patients With Advanced or recurrent endometrial cancer of endometrioid type were treated With Exemestane tablets 25 mg daily.
Patients were grouped according to estrogen receptor status.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 52
Inclusion Criteria
- Advanced or recurrent endometrial cancer not considered for treatment modalities apart from hormonal treatment
- Endometrioid histology
- Age above 18 years
- Post menopausal status
- Performance status 0-2
- Informed consent
Exclusion Criteria
- Congestive heart disease grade III.IV
- History of thromboembolic signs
- Other primary hormonal therapy
- Patients With symptomatic brain metastasis
- Severe hepatic or renal impairment
- Pregnancy, lactation or child bearing potential without adequate contraception
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Exemestane Exemestane Exemestane 25 mg daily
- Primary Outcome Measures
Name Time Method Response rate 6 months Objective response rate within 6 months of treatment
- Secondary Outcome Measures
Name Time Method Progression free survival 2 years Special attention to progression status at 6 months
Trial Locations
- Locations (1)
The Norwegian Radium Hospital
🇳🇴Oslo, Norway