Femara (letrozole) is a well-studied drug and has been approved by the drug authorities for breast cancer patients for 15 years. Letrozole belongs to the group of aromatase inhibitors. It blocks the production of the female steroid hormone oestrogen, which promotes the growth of oestrogen receptor positive cancer cells. By taking one tablet of letrozole (2.5 mg) daily, the body's own oestrogen is reduced by 95%, which can suppress the growth of cancer cells in patients with relapses. Estrogen receptors can also very frequently be detected on the tumor surface in ovarian cancer.
Aim of the study
The aim of this study is to investigate the efficacy of adding letrozole (an extensively studied aromatase inhibitor) to standard maintenance therapy in patients with high- and low-grade epithelial ovarian cancer (including fallopian tube cancer and primary peritoneal cancer) who have previously undergone surgical and chemotherapeutic treatment. Half of the participants received letrozole in addition to standard maintenance therapy, while the other half received a placebo.the main hypothesis of the study is that the additional treatment with letrozole prolongs progression-free survival compared to standard maintenance therapy (superiority study).
Who can take part?
Patients with primary diseases of epithelial ovarian, fallopian tube or peritoneal cancer
Procedure
Participants eligible for this study will be allocated in a 1:1 ratio to either the test group (letrozole) or the control group (placebo). The maximum duration of maintenance therapy is 5 years or until the onset of toxicity symptoms (severe side effects) or progression of the underlying disease, and health status and health-related quality of life are continuously assessed at baseline and during routine follow-up visits, which are scheduled every 12 weeks for the first two years and every 24 weeks for the following three years. The procedures for assessing the participants' state of health are the same as for regular routine ovarian cancer follow-up examinations: blood tests, physical and gynecological examinations and, if necessary, imaging. In addition, participants are asked to complete specific quality of life questionnaires during the study and to wear an activity tracker for a week before the scheduled visits. These assessments will be used to evaluate the efficacy and burden of letrozole compared to standard maintenance therapy. After the maintenance treatment period of 5 years (end of study), survival data will be collected for up to 7 years.
Compensation
None
Original study name
Maintenance therapy with aromatase inhibitors in epithelial ovarian cancer: a randomized, double-blind, placebo-controlled, multicenter phase III study (ENGOT-ov54/Swiss-GO-2/MATAO) including LOGOS (Low Grade Ovarian cancer Sub-study)
BASEC number
2020-00148
Financial support from
Swiss Go Trial Group