Health Condition 1: C569- Malignant neoplasm of unspecifiedovary
Conditions
Interventions
Intervention1: Nil: Nil
Sponsors
AIIMS Bhopal
Eligibility
Inclusion criteria
Inclusion criteria: 1)Patients Aging from 18 to 75 years of age 2)ECOG score less than or equal to 1 3)Primary or recurrent epithelial ovarian cancer 4)Partial or complete Response to perioperative chemotherapy if given (biochemical and imaging) Imaging by RECIST 1.1 criteria 27 Biochemical by ca125 levels as defined by gynecologic cancer intergroup (GCIG). best combined overall response as given by GCIG will be used 5)Cc score 0/1
Exclusion criteria
Exclusion criteria: 1)Stage 4 ovarian cancers 2)Progressive on chemotherapy (biochemical and imaging) 3)ECOG score more than 1. 29 4)Non epithelial histology
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1.To estimate the incidence of post-surgical complication rate (at 30 days) using the Clavien-Dindo Grading system. 2.To estimate the incidence of early mortality (at 30 days). 3.To assess survival outcomes (eg. recurrence-free median survival duration, recurrence-free median survival rate, incidence density of recurrence, etc.) at one year. Timepoint: 1. Incidence of post-surgical complication rate (at 30 days). 2. Incidence of early mortality (at 30 days). 3.survival outcomes at one year. | — |
Secondary
| Measure | Time frame |
|---|---|
| To estimate the incidence of chemotoxicity (at 14 days) among participants who undergo HIPEC post-cytoreductive surgery for management of Ovarian cancerTimepoint: at 14 days;5. To determine the change in the health-related quality of life (QoL) among patients undergoing CRS + HIPEC between before surgery and at 6 monthsTimepoint: before surgery 6 months post surgery | — |
Countries
India
Contacts
Public ContactAvinash Ramakrishnan
AIIMS, BHOPAL
Outcome results
None listed