Health Condition 1: C569- Malignant neoplasm of unspecifiedovary Health Condition 2: O- Medical and Surgical
Conditions
Interventions
Intervention1: normothermic intraperitoneal chemotherapy administration during primary cytoreduction surgery: Eligible patients of advanced epithelial ovarian malignancy who have achieved optimum cyto
Sponsors
All India Institute of Medical Sciences Rishikesh
Eligibility
Inclusion criteria
Inclusion criteria: 1) Epithelial ovarian or fallopian tube or primary peritoneal cancer FIGO 2023 stage III to IVA clinically or radiologically 2)Optimum cytoreduction i.e. R0 or R1(no macroscopic disease visible) achievable during upfront cytoreduction 3)Good performance score, ECOG 2 or less
Exclusion criteria
Exclusion criteria: 1)Non epithelial cancer or borderline ovarian cancer 2)FIGO 2023 Stage I or II or IVB of epithelial ovarian, fallopian tube or primary peritoneal cancer 3)Serious intercurrent illness or medical condition 4)No prior diagnosis or treatment of any other cancer within last five years 5) ECOG 3 or more 6) Diffuse infiltration of stomach, dueodenum, head or middle of pancrease 7)Involvement of celiac trunk, hepatic arteries, left gastric artery, liver hilum, lung parenchyma metastasis, unresectable lymph nodes or brain metastasis
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1)Intraoperative adverse events graded according to Common terminology criteria for adverse events CTCAE 5.0. 2)Postoperative adverse events (within 30 days) according to Clavien Dindo classification 3)Duration of hospital stay in days 4)Preoperative and post-surgery CA-125(U/ml) values after four weeks in both groups. Timepoint: 30 days, 60 days, 6 months and 12 months from the date of surgery | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. To calculate the delay in days from the day of surgery until 1st cycle of adjuvant intravenous chemotherapy 2. To calculate the disease recurrence rate from the time of surgery up to 12 months during follow-up 3. Quality of life as determined by EQ5D5L questionnaire Timepoint: 30 days, 60 days, 6 months and 12 months from the date of surgery | — |
Countries
India
Contacts
Public ContactProf Shalini Rajaram
AIIMS Rishikesh
Outcome results
None listed