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
Parallel
Letrozole 2.5mg
DrugAromatase inhibitor
Placebo
Other interventionPlacebo tablet of Femara
Progression-free survival (PFS) for each study group
PFS defined as the time from the date of first IMP administration until the date of progression (recurrence) or death by any cause in the absence of progression. Assessment of progression (recurrence) is generally indicated by SYMPTOMS and will be assessed by the investigator most commonly on the basis of CT scans of the pelvis, abdomen and thorax, according to RECIST v1.1 criteria recommended and mostly presented by an elevated CA-125 level. Elevated CA-125 levels alone shouldn't be considered as progression. Progression assessment according to local standard of care, however, is similarly acceptable.
Overall survival (OS) for each study group
OS defined for each patient as the time from the date of first IMP administration until the date of death from any cause. Patients not having an event at the time of analysis will be censored at the date they were last known to be alive.
Quality-adjusted progression free survival (QAPFS) for each study group
QAPFS defined as the time from the date of first IMP administration until the date of progression (recurrence) or death by any cause in the absence of progression under consideration of the quality of life during this period. QAPFS incorporates progression-free survival (quantity) and quality of life during this period into a measure of net clinical benefit: QAPFS = PFS (years or months) x QoL (utility value). Utility values derived from the EQ-5D-L5 questionnaire will be used.
Time to first subsequent treatment (TFST) for each study group
TFST defined for each patient as the time from the date of first IMP administration until the date the patient started the next (second-line) subsequent anticancer treatment. Patients not receiving a subsequent anticancer treatment at the time of analysis will be censored at the date they were last known to be alive.
Quality-adjusted time without symptoms of toxicity (Q-TWiST) for each study group
Q-TWiST defined as the Quality adjusted Time Without appearance of any Symptoms of Toxicity related to either the progression of the cancer or side effects of the trial medication from the date of first IMP administration until dead. The Q-TWiST analysis considers the following three health states: * (1) the period experiencing toxicity (TOX) * (2) the period before progression without experiencing toxicity (TWiST) * (3) the period after relapse (REL) These periods are assigned preference utilities (u), which will be derived using the generic EQ-5D-5L questionnaire. The Q-TWiST will be calculated as the weighted sum of the time spent in each health state: Q-TWiST = uTox\*TOX + TWiST + uRel\*REL where u denotes the assigned utility for each respective health state.
Click on the lead sponsor to view all of their trials.
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
