Study to determine the possibility of treating women with ovarian and related cancers with chemotherapy, some of which is given directly into the abdomen as well as into the vein. It will also determine how safe it is, what side-effects it causes and how it affects quality of life.
A Single Arm Phase II Trial of Intraperitoneal Chemotherapy with Paclitaxel and Cisplatin after Optimal Debulking Surgery for Ovarian, Peritonuem and Fallopian Tube Cancers assessing the feasibility, toxicity and effects on quality of life of a modified GOG 172 (Gynaecologic Oncology Group) intraperitoneal (IP) regimen.
ANZGOG, University of Sydney
35 participants
Sep 14, 2007
Interventional
Conditions
Summary
Recent studies by the US Gynecologic Oncology Group have found that patients, who are given chemotherapy directly into the abdominal cavity as well as through a vein, live longer than those who are given chemotherapy through a vein only. TRIPOD is a study which will determine if it is possible and safe to treat ovarian cancer patients, in Australia and New Zealand with chemotherapy given directly into the abdomen as well as through a vein. This study will enroll at least 35 patients which will take approximately 1 year. The aim of the study is to determine if it is possible to treat women with ovarian cancer with chemotherapy, some of which is given directly into the abdomen as well as into the vein. It will also determine how safe it is, what side-effects it causes and how it affects quality of life.
Eligibility
Plain Language Summary
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Interventions
IP catheter either at or within 6 weeks of primary surgery. Trial registration following catheter insertion. Chemotherapy Regimen Paclitaxel 135mg/m2 IV (Intravenous) over 3 hours (Day 1) Cisplatin 75mg/m2 IP (Day 2) Paclitaxel 60mg/m2 IP (Day 8) Treatment will consist of 6 cycles given at 3 weekly intervals
Locations(1)
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ACTRN12606000502538