Health Condition 1: O- Medical and Surgical
Conditions
Interventions
Intervention1: Normothermic Intraperitoneal Chemotherapy (NIPEC) once in patients undergoing Interval cytoreductive Surgery
: The intervention arm will recieve Normothermic Intraperitoneal Chemothe
Sponsors
All India Institute Of Medical Sciences
Eligibility
Inclusion criteria
Inclusion criteria: 1. Patients with advanced high grade serous epithelial carcinoma ovary (Stage III-IV), fallopian tube carcinoma or primary peritoneal cancer with CC0/CC1 resection at the time of interval CRS 2. Age: 18-70 years. 3. ECOG performance status 0-2. 4. Adequate organ function with the following criteria: White blood cell (WBC) more than or equal to 4000/ul; Absolute Neutrophil Count (ANC) more than or equal to1500/ul; Platelet count more than or equal to 100 103/ul; AST less than or equal to 100 IU/L; (ALT) less than or equal to100 IU/L; Serum total bilirubin less than or equal to 1.5 mg/dL. Serum Creatinine less than 1.2 mg/dl
Exclusion criteria
Exclusion criteria: 1.Suboptimal debulking 2.Presence of extra abdominal disease at response assessment precluding complete cytoreduction 3.If Bevacizumab was given during NACT 4. Failure to give consent 5.Non-epithelial or type 1 EOC 6.Pre-existing renal or liver disease 7.Known hypersensitivity to any of the study drugs, study drug classes, or excipients in the formulation 8.Dehydration or intercurrent disease that contraindicates hyperhydration (including cardio-respiratory disease).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1.Proportion of patients who recieved intraoperative chemotherapy and complete 6 cycles of systemic adjuvant chemotherapy. 2.Total number of chemotherapy cycles received, dose reductions or change in schedule 3. The frequency and severity of adverse events (AEs) within 30days , of grade 3 or higher like anemia, bowel function measures Timepoint: 1.Observe for early toxicity and side effects for 24 hours 2. Observe for late toxicities at 30 days | — |
Secondary
| Measure | Time frame |
|---|---|
| 1.To compare the post-operative inflammatory & immune marker profiles, including CRP, NLR, PLR, Systemic immune-inflammatory index (SII: NxP/L), & selected T cell populations in patients receiving Interval CRS alone versus CRS with NIPEC. 2.To compare the PROs of bowel functioning, pain, fatigue/lack of energy, abdominal symptoms & burden of disease & treatment assessed using the EORTC QLQ-C30, QLQ-OV28, bowel scales of the QLQ-CR29. Timepoint: 1.Compare immune markers at 0,7, 28 days 2.PROs at 0,7,28 days | — |
Countries
India
Contacts
Public ContactDr Seema Singhal
All India Institute Of Medical Sciences
Outcome results
None listed