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Trial Details
Trial status:
Closed
Recruitment start date:
09/05/2011
Funder:
Cancer Research UK
Sponsor:
Canadian Cancer Trials Group
Chief Investigator:
Dr Chris Gallagher
Recruitment target:
770
EudraCT number:
2009-012859-21
Contact details:
ctc.PETROC@ucl.ac.uk
Lay summary:
PETROC
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 (PETROC/OV21)
Description
Design: This is an international randomised, non-blinded multicentre phase II Gynecologic Cancer Intergroup trial coordinated by the NCIC Clinical Trials Group in conjunction with SWOG (US), the Cancer Research UK and UCL Cancer Trials Centre (UCL CTC, UK) and the Grupo Espańol de Investigación en Cáncer de Ovario (GEICO, Spain). When the trial transitions from its initial randomized phase II to expanded randomized phase II stage, it is expected that additional member groups of the Gynecologic Cancer Intergroup (GCIG) may participate in this trial. The objective of this trial is to determine if intraperitoneal platinum-based chemotherapy leads to improved 9 month progression rates post randomization, progression free and overall survival as compared with intravenous chemotherapy in women who have had optimal debulking surgery following 3-4 courses of standard intravenous platinum-based chemotherapy. 
Treatment:
Initial Phase II:

ARM 1: Paclitaxel 135 mg/m2 intravenous day 1 plus Carboplatin AUC 5 if measured GFR or AUC6 if calculated GFR intravenous day 1; Paclitaxel 60 mg/m2 intravenous day 8. Cycles given Q 21 days x 3 cycles

ARM 2: Paclitaxel 135 mg/m2 intravenous day 1 plus Cisplatin 75 mg/m2 intraperitoneal day 1; Paclitaxel 60 mg/m2 intraperitoneal day 8. Cycles given Q 21 days x 3 cycles

ARM 3: Paclitaxel 135 mg/m2 intravenous day 1 plus Carboplatin AUC 5 if measured GFR or AUC6 if calculated GFR intraperitoneal day 1; Paclitaxel 60 mg/m2 intraperitoneal day 8. Cycles given Q 21 days x 3 cycles


Extended Phase II (Arm 2 dropped prior to Expanded Phase II): 

ARM 1: Paclitaxel 135 mg/m2 intravenous day 1 plus Carboplatin AUC 5 if measured GFR or AUC6 if calculated GFR intravenous day 1; Paclitaxel 60 mg/m2 intravenous day 8. Cycles given Q 21 days x 3 cycles

ARM 3: Paclitaxel 135 mg/m2 intravenous day 1 plus Carboplatin AUC 5 if measured GFR or AUC6 if calculated GFR intraperitoneal day 1; Paclitaxel 60 mg/m2 intraperitoneal day 8. Cycles given Q 21 days x 3 cycles
Key inclusion/exclusion criteria: Patients must have received 3-4 cycles ofneoadjuvant platinum-based chemotherapy following newly diagnosed,histologically confirmed advanced epithelial ovarian cancer, serous typeperitoneal or fallopian tube cancer; FIGO Clinical Stage IIB to III (Stage IVon basis of pleural effusion only with positive cytology also eligible) atdiagnosis.
Duration of recruitment: Initial Phase II: 3 years, Expanded Phase II: 1 year
Aim
The objective of this trial is to determine if intraperitoneal platinum-based chemotherapy leads to improved 9 month progression rates post randomization, progression free and overall survival as compared with intravenous chemotherapy in women who have had optimal debulking surgery following 3-4 courses of standard intravenous platinum-based chemotherapy for newly diagnosed Stage IIB-III (and Stage IV on basis of pleural effusion only with positive cytology) epithelial ovarian cancer (EOC),serous type peritoneal or fallopian tube cancer. The trial will be conducted in two stages, the initial phase II (to identify which of the two intraperitoneal regimens will continue into the expanded phase II portion of the trial) and expanded phase II portion (to compare the efficacy of the selected IP chemotherapy regimen (Arm 3: IV paclitaxel and IP carboplatin plus day 8 IP paclitaxel) versus IV carboplatin plus paclitaxel (Arm 1)).
Trial protocols
Trial protocols must not be applied to patients treated outside trials. UCL CTC can only ensure that approved trial investigators are provided with amendments to protocols.
No protocols have been currently made available for download
Trial documents
No documents have been currently made available for download
Contact Us
Cancer Research UK & UCL Cancer Trials Centre
University College London
90 Tottenham Court Road
London
W1T 4TJ

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Email:
ctc.enquiries@ucl.ac.uk
Telephone:
+44 (0)20 7679 9898 (General CTC Enquiries)
Fax:
020 7679 9899
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