Peritoneal Treatment of Ovarian Cancer (PETROC/OV21) v1.0
Research type
Research Study
Full title
A PHASE II/III STUDY OF INTRAPERITONEAL (IP) PLUS INTRAVENOUS (IV) CHEMOTHERAPY VERSUS IV CARBOPLATIN PLUS PACLITAXEL IN PATIENTS WITH EPITHELIAL OVARIAN CANCER OPTIMALLY DEBULKED AT SURGERY FOLLOWING NEOADJUVANT INTRAVENOUS CHEMOTHERAPY
IRAS ID
15328
Contact name
Chris GALLAGHER
Sponsor organisation
NCIC Clinical Trial Group (NCIC CTG)
Eudract number
2009-012859-21
Clinicaltrials.gov Identifier
Research summary
Epithelial ovarian carcinoma is the leading cause of death from gynaecologic malignancies in the developed world. Approximately 3/4 of women have advanced ovarian cancer at the time of diagnosis. Standard therapy for this type of cancer is primary surgery followed by platinum/taxane combined chemotherapy. Despite good response rates, 75% of patients will relapse and die from their disease. The standard of care has been primary surgery followed by intravenous chemotherapy however recent trial findings have challenged both the sequence and the route of delivery of the chemotherapy. Firstly survival was the same for patients with advanced disease whether they received surgery or chemotherapy first, while the surgical morbidity was reduced in those who had surgery after chemotherapy. Secondly intraperitoneal delivery of the chemotherapy in three randomised trials has increased survival but at the expense of a greater risk of toxicity. We wish to investigate how this new information may be incorporated into clinical practice in a Cancer Research UK funded multicentre phase II/III trial to examine the feasibility of treating patients with unresectable disease with primary intravenous chemotherapy followed by delayed surgery and intraperitoneal (IP) chemotherapy. Three arms of chemotherapy treatment will be compared in the phase II study; 150 patients will be randomly assigned to receive standard chemotherapy: IV paclitaxel & carboplatin, or one of two experimental treatment arms: IV & IP paclitaxel plus IP carboplatin or IV & IP paclitaxel plus IP cisplatin. Chemotherapy will be administered in three cycles over a total of nine weeks. After treatment patients will be followed-up until death. The primary comparisons between treatments will be: 9-month progression rate following randomisation, toxic effects and rate of completion of 3 cycles of IP treatment (as an assessment of feasibility and toxic effects). Recruitment for this part of the trial will last approximately 2 years. The trial will then continue into a phase III. One of the experimental arms will be taken forward and recruitment will continue to a total sample size of 830 patients.
REC name
East Midlands - Leicester South Research Ethics Committee
REC reference
10/H0402/42
Date of REC Opinion
30 Jul 2010
REC opinion
Further Information Favourable Opinion