Role of surgery and heated chemotherapy in the abdominal cavity for patients with recurrent ovarian cancer
- Conditions
- Health Condition 1: null- Recurrent ovarian cancer
- Registration Number
- CTRI/2017/09/009607
- Lead Sponsor
- Investigator initiated trial
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Open to Recruitment
- Sex
- Not specified
- Target Recruitment
- 15
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 <= 2
Absolute neutrophil count > 1,500/mm³
WBC > 4,000/mm³ and Platelet count 150,000/mm³
INR <= 1.5 Patients on therapeutic anticoagulant for unrelated medical condition such as atrial fibrillation or anti-thrombocyte treatment allowed provided treatment can be withheld for operation
Total serum bilirubin <= 1.5 mg/dL
Alkaline phosphatase < 2.5 times upper limit of normal (ULN)
SGOT < 1.5 times ULN
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
Patients who have platinum resistant recurrence ( < 6 months of protocol first line treatment )
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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method To study the Progression â?? Free survival of these regimens. <br/ ><br>ii) To study the toxicities associated with these regimens.Timepoint: 2 years