The purpose of this study is to evaluate the efficacy of addition of letrozole to the standard maintenance therapy in subjects following a primary diagnosis of Estrogen-receptor (ER) positive high and low grade epithelial ovarian cancer (including fallopian tube and primary peritoneal cancer) and subsequent primary treatment surgery and chemotherapy. Half of the participants will receive to the standard maintenance treatment, letrozole, whilst the other half receives placebo.
The study's primary hypothesis is that the treatment with letrozole increases progression free survival in comparison to the maintenance standard treatment (superiority trial).
Patients must be ≥ 18 years of age
Willing and able to attend the visits and to understand all study-related procedures.
Primary, newly diagnosed FIGO Stage II to IV and histologically confirmed low or high grade serous or endometrioid epithelial ovarian/fallopian tube/peritoneal cancer
(Interval-) debulking performed ECOG-Performance Status 0-2
Progressive disease at the end of adjuvant treatment as defined in chapter 9.2.1 of protocol
Women of childbearing potential (not having undergone a surgical or radiation sterilization and not getting a surgical resection, prior to the intervention in the therapeutical maintenance setting)
Pregnant or lactating women
Any other malignancy within the last 5 years which has impact on the prognosis of the patient
Swiss GO Trial Group
Lead sponsor
AGO Study Group
Collaborator
Arbeitsgemeinschaft Gynaekologische Onkologie Austria
Collaborator
Reliable Cancer Therapies
Collaborator
Krebsliga Schweiz
Collaborator
Stiftung Guido Feger
Collaborator
Hoffmann-La Roche
Collaborator
Helsana AG
Collaborator
Novartis Pharmaceuticals
Collaborator
Anticancer Fund, Belgium
Collaborator