Health Condition 1: null- Recurrent ovarian cancer
Conditions
Interventions
Intervention1: HIPEC: If the patient meets all the operable criteria, cytoreductive surgery is carried out followed by Hyperthermic intraperitoneal chemotherapy with cisplatin 75mg/m2 in 2L/m2 of per
Sponsors
Investigator initiated trial
Eligibility
Inclusion criteria
Inclusion criteria: A. Patients affected by a peritoneal recurrence of ovarian cancer. B. DISEASE AMENABLE TO COMPLETE CYTOREDUCTIVE SURGERY AS INDICATED BY: Ovarian cancer limited to the abdominal cavity with or without extra-peritoneal spread considered resectable at preoperative and intra-operative evaluation. No clinical, biochemical or radiological signs of biliary obstruction, ascites. Small volume of disease in the gastro-hepatic ligament defined as mass less than 5 cm in the epigastric region on cross-sectional imaging. No cross-sectional imaging findings indicative of multi-segmental (More than- 1 site) small bowel obstruction, small bowel loops matted together, or gross disease of the small bowel mesentery characterized by distortion, thickening, or loss of mesenteric vascularity. Absence of unresectable deposits over the small intestinal serosa/ mesentery or more than 1/3 rd of small bowel involvement, No clinical or radiological evidence of distant disease excluding the supraclavicular, inguinal metastases and pleural effusion. C. PATIENT CHARACTERISTICS: Age over 18 and under 70 years ECOG-performance status Absolute neutrophil count > 1,500/mm³ WBC > 4,000/mm³ and Platelet count 150,000/mm³ INR Total serum bilirubin Alkaline phosphatase SGOT Serum creatinine and Blood Urea Nitrogen are normal No history of severe congestive heart failure or severe pulmonary diseases. Patients who are status post-revascularization procedures with satisfactory cardiac function are eligible No acute myocardial infarction within the past 6 months No significant history of a medical problem or co-morbidity (e.g., severe congestive heart failure or active ischemic heart disease) that would preclude a major abdominal operation No concurrent second malignancy requiring systemic therapy No psychiatric or addictive disorders, or other conditions that would preclude the patient from meeting the study requirements
Exclusion criteria
Exclusion criteria: Patients who have platinum resistant recurrence ( Non-epithelial ovarian cancer or borderline ovarian tumor Patients affected by major depressive disorder even in treatment or minor mood disorders Patients with severe impairment of respiratory, hepatic or renal function Patients with cardiac, neurological or metabolic uncontrolled pharmacologically disease Patients with active infection or other neoplastic disease in progress Patients with bowel obstruction Inadequate bone marrow function No clear-peritoneal disease at surgical exploration Patients on maintenance therapy with Antiangiogenic drugs
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To study the 3-year overall survival of patients of recurrent ovarian cancer patients treated with CRS and HIPEC along with Neoadjuvant/ adjuvant chemotherapy in 15 patients.Timepoint: Survival at 3 years from completion of treatment | — |
Secondary
| Measure | Time frame |
|---|---|
| To study the Progression â?? Free survival of these regimens. ii) To study the toxicities associated with these regimens.Timepoint: 2 years | — |
Countries
India
Contacts
Public ContactDrUjwala
Cancer Institute (WIA)
Outcome results
None listed