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. 2016 Jan 12;2016(1):CD005340. doi: 10.1002/14651858.CD005340.pub4

Hyperthermic IP therapy.

Trial name or title Secondary Debulking Surgery +/‐ Hyperthermic Intraperitoneal Chemotherapy in Stage III Ovarian Cancer (NCT00426257)
Methods This phase III randomised, open‐label trial compares a single intraperitoneal perfusion of chemotherapy under hyperthermic conditions immediately after interval debulking surgery (OVHIPEC) versus no intraperitoneal therapy
Participants Women with stage III ovarian, peritoneal or tubal carcinoma who are eligible for interval debulking surgery either following primary chemotherapy or following incomplete primary debulking and chemotherapy. Participants must be between 18 and 76 yr old and not have had relevant competing previous malignancies. Estimated enrolment = 280 women
Interventions Arm 1: Secondary debulking surgery with hyperthermic intraperitoneal chemotherapy (cisplatin 100 mg/m2 at the end of surgery)
Arm 2: Secondary debulking surgery
Outcomes Primary: duration of recurrence free survival following completion of treatment. Secondary: toxicity and morbidity, quality of life, tumour response following treatment and overall survival
Starting date Feb 2007
Contact information Willemien J van Driel, MD Ph: +31 20 512 2975 Email: w.v.driel@nki.nl
Notes Estimated completion date 2013