Health Condition 1: C569- Malignant neoplasm of unspecifiedovary
Conditions
Interventions
Intervention1: T. Letrozole 2.5 mg once a day: Oral T Letrozole 2.5mg OD
Supportive Care -Oral calcium 500mg OD and alendronate 70mg once a week
These will be continued as maintenance till disease pr
Sponsors
Tata Memorial Centre
Eligibility
Inclusion criteria
Inclusion criteria: Inclusion criteria 1. Age at least 18 years at diagnosis 2. ECOG performance status 0-2 ,post treatment completion and before randomization 3. High grade ovarian cancer 4. FIGO stage III/IV epithelial ovarian cancer 5. Patients who have undergone primary or interval debulking surgery (total abdominal hysterectomy, bilateral salpingo-oophorectomy, omentectomy) and completed at least 6 cycles of platinum based chemotherapy 6. Written, signed, informed consent 7. Post 3-6 weeks of treatment completion blood parameters-Hb >8gm/dl, ANC greater than or equal to 1.5 x 10 9/L, platelets greater than 100 x 10 9/L, Creatinine less than or equal to 1.5 x ULN, total bilirubin less than or equal to 1.2 mg/dl, AST and ALT less than or equal to 2.5 x ULN.
Exclusion criteria
Exclusion criteria: Exclusion criteria: 1. No h/o any other invasive malignancy (prior or current). 2. Unable to take hormonal therapy orally. 3. Contraindication to Letrozole-known hypersensitivity to letrozole, its active substance, or to any of the excipients. 4. Patients on maintenance Bevacizumab or PARP inhibitors
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To determine progression free survival (PFS) in patients with ER/PR Allred total score â?¥6.Timepoint: Progression free survival (PFS) will be calculated from date of randomisation to date of progression, death or date of last follow up, whichever is earlier Progression will be defined radiologically as per RECIST 1.1. | — |
Secondary
| Measure | Time frame |
|---|---|
| Tertiary Outcomes For patients with ER/PR ATS6 , PFS and OS will be calculatedTimepoint: PFS will be calculated from date of randomisation to date of progression, death or date of last follow up, whichever is earlier.Similay for the same patients Overall survival (OS) will be determined as time from randomisation to death due to any cause or date of last follow up;To evaluate overall survival (OS) in patients with ER/PR Allred total score â?¥6.Timepoint: Overall survival (OS) will be determined as time from randomisation to death due to any cause or date of last follow up. ;To assess toxicities using CTCAE v 5.0 in patients with ER/PR Allred total score â?¥6.Timepoint: At each clinical follow up 3 monthly or earlier if symptomatic;QOL of all study patients will be documented as per the FACT O v 4 at pre-specified timesTimepoint: QOL of all study patients will be documented as per the FACT O v 4 at pre-specified times i.e .just after randomization and at follow up at 6,12,18,24 months | — |
Countries
India
Contacts
Public ContactDr Jaya Ghosh
Tata Memorial Centra
Outcome results
None listed