Health Condition 1: C569- Malignant neoplasm of unspecifiedovary
Conditions
Interventions
Intervention1: Total parietal peritonectomy: Removal of the entire parietal peritoneum will be performed according to the prespecified surgical protocol. This procedure is performed during surgery.
D
Sponsors
Society of peritoneal surface oncology, India
Eligibility
Inclusion criteria
Inclusion criteria: 1. ECOG performance status 1 or less than 1, ASA 1 or 2 2. Normal bone marrow, hepatic and renal function 3. Histological proven FIGO stage III-C and IV-A primary epithelial ovarian, fallopian tube and primary peritoneal cancer treated by neoadjuvant chemotherapy 4. Neoadjuvant chemotherapy administered for unresectable disease or patients general condition 5. Baseline imaging should indicate stage III-C/IV-A disease with largest extra-pelvic focus of disease measuring more than 2 cm 6. All the intra-abdominal and intra-thoracic disease should be completely resectable 7. Patients needing thoracic procedures for stage IV-A will be included if the disease is completely resectable 8. Inguinal and supradiaphragmatic lymph nodes if completely resectable
Exclusion criteria
Exclusion criteria: 1. Patients refusing consent 2. Patients medically unfit for major abdominal surgery 3. Patients with solid organ metastases 4. Patients who have received more than one line of neoadjuvant treatment 5. Patients who have received neoadjuvant intraperitoneal treatment 6. Patients undergoing minimally-invasive interval cytoreductive surgery
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Progression-free survival which is defined as the time interval between the date of surgery and the clinical evidence of recurrence or death whichever occurs first. Platinum resistant recurrence which is defined as the recurrence occurring within 6 months of the last dose of platinum based chemotherapy (co-primary end point). Timepoint: Progression-free survival which is defined as the time interval between the date of surgery and the clinical evidence of recurrence or death whichever occurs first. Platinum resistant recurrence which is defined as the recurrence occurring within 6 months of the last dose of platinum based chemotherapy (co-primary end point). | — |
Secondary
| Measure | Time frame |
|---|---|
| Overall survival which is defined as the time interval between the date of surgery and death due to any cause 90-day major morbidity and mortality Obstruction-free survival Time interval between surgery and intestinal obstruction that cannot be reversed surgically. Patients who have obstruction due to adhesions or single-site disease causing obstruction that is relieved surgically for at least 3 months will still be considered obstruction free. Ascites-free survival Time interval between surgery and development of ascites that needs repeated tapping Timepoint: 1, 3 and 5 years from the date of surgery | — |
Countries
India
Contacts
Public ContactAditi Bhatt
Shalby Cancer and Research Institute
Outcome results
None listed