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About
In Western industrialized countries, endometrial cancer is the most common malignancy of the female reproductive tract.
The general therapy options are surgery, radiotherapy, chemotherapy and endocrine therapy. This trial will investigate the efficacy and safety of letrozole in the treatment of advanced or recurrent hormone receptor-positive endometrial cancer .
Enrollment
Sex
Ages
Volunteers
Inclusion criteria
Signed informed consent
Age > 18 years
Presence of histologically proven adenocarcinoma or adenosquamous carcinoma of the endometrium
Presence of advanced or recurrent endometrial cancer, FIGO stage I-IV, incurable with surgery and/or radiation therapy
Documented ER and/or PgR positive endometrial cancer. Hormone receptor positivity is defined according to routine practice at each participating laboratory.
Patient must be postmenopausal defined as
Presence of measurable disease (by clinical/radiological examination - according to RECIST criteria : minimum indicator lesion size : 20 mm (unless spiral CT scan in which case > 10 mm)
ECOG performance status of 0, 1 or 2
Adequate bone marrow function (WBC ≥ 3.5 x 1'000'000'000/L and platelets ≥ 100.0 x 1'000'000'000/L) and hemoglobin > 10.0 g/dl
Adequate renal function (creatinine < 120 µmol/L) and hepatic function (bilirubin < 25 µmol/L, AST (SGOT < 60 U/L)
Minimum life expectancy of at least 6 months
Patients who are accessible for treatment and follow-up
Exclusion criteria
Additional protocol-defined inclusion/exclusion criteria may apply.
Primary purpose
Allocation
Interventional model
Masking
26 participants in 1 patient group
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Data sourced from clinicaltrials.gov
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