Health Condition 1: C569- Malignant neoplasm of unspecifiedovary
Conditions
Interventions
Intervention1: Total parietal peritonectomy performed at the time of interval cytoreductive surgery: Patients with stage III-C epithelial serous ovarian, fallopian tube and primary peritoneal cancer w
Sponsors
No sponsor
Eligibility
Inclusion criteria
Inclusion criteria: All patients with stages III C (new FIGO classification) serous epithelial ovarian, fallopian tube and primary peritoneal cancer 1. Age between 18-75 years• ECOG performance status of >2, ASA 1 or 2 2. in case of pleural effusion cytology should be negative for tumour cells â?¨ 3. Histologically/cytologically proven epithelial serous ovarian, fallopian tube or primary peritoneal carcinoma 4. In case diagnosis is made based on cytology only Normal mammogram ( 200 kU/l and Serum CA125/CEA ratio > 25. If the serum CA125/CEA ratio is Omental cake or other metastases larger than 2 cm in the upper abdomen and/or regional lymph node metastasis irrespective of size (CT/MRI or ultrasound or laparoscopy) 5. Laboratory values: serum creatinine 3.5 x 109/l; platelets > 100 x 109 /l
Exclusion criteria
Exclusion criteria: 1. Patient refusing to consent 2. Patients with non-serous histologies like endometroid adenocarcinoma, mucinous carcinoma, clear cell carcinoma and other rare histologies 3. Patients with distant organ metastases like liver and lung metastases 4. Patients who do not undergo both surgery and chemotherapy 5. Patients who develop disease progression on chemotherapy (evaluated according to the RECIST criteria) 6. History of breast cancer or previous malignancies within 5 years prior to inclusion, with the exception of radically excised basal cell or squamous cell skin cancer or carcinoma in situ of the cervix 7. Patients with active infection or other concurrent medical condition that could interfere in the ability of â?¨patients to receive the proposed treatment according to protocol; â?¨ 8. Patients with performance status (ECOG) >2; â?¨ 9. Patients with complete bowel obstruction; â?¨ 10. Abnormal bone marrow indices or renal and liver function; â?¨ ASA IV or V. â?¨
Design outcomes
Secondary
| Measure | Time frame |
|---|---|
| â?¢ To study the impact of total parietal peritonectomy with or without HIPEC on overall survival. â?¢ To compare the 30 and 90-day morbidity between different treatment arms â?¢ To assess the quality of life outcomes in all patients To study the impact of pathological response grade on survivalTimepoint: 30 days 60 days 3 months 6 months 18 months 3 years 5 years 7 years | — |
Primary
| Measure | Time frame |
|---|---|
| â?¢ To study the impact of total peritonectomy with or without HIPEC on progression free survival. Timepoint: 30 days 60 days 3 months 6 months 18 months 3 years 5 years 7 years | — |
Countries
India
Contacts
Public ContactDr Sakina Shaikh
Zydus Hospital
Outcome results
None listed