Health Condition 1: C569- Malignant neoplasm of unspecifiedovary
Conditions
Interventions
Intervention1: post-surgery intraperitoenal (IP) chemotherapy: normothermic intraperitoneal cisplatin at 100 mg per m2 instilled within the abdomen for 60 minutes after surgery
Control Intervention1:
Sponsors
Jawaharlal Institute of Postgraduate Medical Education and Research JIPMER
Eligibility
Inclusion criteria
Inclusion criteria: Patient giving informed consent Newly diagnosed FIGO stage 3 or 4a epithelial ovarian cancer After optimal cytoreduction after interval surgery Must have received 3 or 4 cycles of paclitaxel nd carboplatin neoadjuvant chemotherapy ECOG performance status 0 or 1 at enrolment Negative pregnancy test in women of child bearing potential adequate organ function
Exclusion criteria
Exclusion criteria: Prior surgery for ovarian cancer other than biopsies Serious medical illnesses Uncontrolled infections Pre existing neuropathy more than grade 1 Known to have borderline or low grade cancer Prior partial therapy elsewhere intraoperative complications rendering patient unfit for IP chemotherapy Time from last chemotherapy to surgery less than 8 weeks Bevacizumab as part of neoadjuvant schedule
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| relapse free survivalTimepoint: 3 years | — |
Secondary
| Measure | Time frame |
|---|---|
| overall survivalTimepoint: 3 years;toxicity of therapyTimepoint: 6 months;surgical morbidityTimepoint: 1 month;quality of lifeTimepoint: 6 months | — |
Countries
India
Contacts
Public ContactRebekah C
Jawaharlal Institute of Postgraduate Medical Education and Research (JIPMER)
Outcome results
None listed