Endometrial Cancer
Conditions
Keywords
Endometrial cancer
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.
Interventions
DRUGExemestane
One tablet Exemestane 25 mg daily
Sponsors
Nordic Society of Gynaecological Oncology - Clinical Trials Unit
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Response rate | 6 months | Objective response rate within 6 months of treatment |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Progression free survival | 2 years | Special attention to progression status at 6 months |
Other
| Measure | Time frame | Description |
|---|---|---|
| Toxicity | Up to 2 years | Asses toxicity to the treatment using Common Toxicity Criteria for Adverse Effects |
Countries
Norway
Outcome results
None listed