Health Condition 1: C569- Malignant neoplasm of unspecifiedovary
Conditions
Interventions
None listed
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: 1.Consenting patients of Age greater than equal to 18 years 2.Planned for Carboplatin based treatment for newly diagnosed Epithelial Ovarian Cancer 3.Histo-pathological /Cytology Diagnosis
Exclusion criteria
Exclusion criteria: 1.Contra indication for baseline DTPA Renogram 2.Known history of CKD 3.Documented Viral Hepatitis 4.Immuno-compromised 5.Second malignancy 6.Carboplatin Allergy 7.Previous Treatment with Platinum
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary Outcome: 1. To assess the root mean square error of the estimated GFR by the 3 different methods ââ?¬â?? Cockroft Gault ââ?¬â?? CKD EPI (BSA adjusted) ââ?¬â?? MDRD 6 (BSA adjusted) Compared to the measured GFR using Tc99 DTPA (plasma sampling method). Timepoint: Baseline | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary Outcomes: 1. To estimate the proportion of patients with APE (absolute percentage error) greater than 20% by the 3 methods of eGFR. 2. In a subset of patients estimate the target AUC with the AUC achieved as measured by carboplatin pharmacokinetics 3. Toxicity Assessment: Hematological Toxicities: Thrombocytopenia, Anemia, Neutropenia , Febrile Neutropenia As per CTCAE ver 5.0 in first cycleTimepoint: Baseline and 1 month | — |
Countries
India
Contacts
Tata Memorial Centre