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Trial Details
Trial status:
Closed
Recruitment start date:
07/10/2013
Funder:
Oxford BioMedica (UK) Ltd
Sponsor:
UCL
Chief Investigator:
Dr Agnieszka Michael
Recruitment target:
100
EudraCT number:
2011-001836-44
Contact details:
ctc.trioc@ucl.ac.uk
Lay summary:
TRIOC
A phase II study to assess the activity of TroVax (MVA-5T4) versus placebo in patients with relapsed asymptomatic epithelial ovarian, fallopian tube or primary peritoneal cancer
Description
Design: TRIOC is a prospective multicentre phase II trial in patients with epithelial ovarian, fallopian tube or primary peritoneal cancer who develop asymptomatic relapse as confirmed by either elevated CA-125 following first line treatment, or low volume disease on the CT scan and rising CA-125, comparing TroVax® to placebo. Patients who are confirmed to have complete remission after second line chemotherapy and develop asymptomatic relapse can also be entered into the trial. 
Treatment: Patients will be registered to receive TroVax® with all patients receiving 8 injections across a 25 week period. Discontinuation of treatment requires progression by RECIST v1.1 and irRC. Trial drug will be stopped in the event that an investigator considers its administration to be related to an unacceptable grade 3 or 4 toxicity. 
Key inclusion/exclusion criteria: Patients must have histologically or cytologically confirmed advanced epithelial ovarian carcinoma, fallopian tube carcinoma or primary peritoneal carcinoma, have completed cytoreductive surgery during first line therapy, completed first line platinum-based chemotherapy or completed first-line and second-line chemotherapy with complete response to second line treatment according to RECIST v.1.1. Patients must have an ECOG performance status of between 0-1, a life expectancy of ≥ 6 months and developed asymptomatic relapse as defined by CA-125 ≥ 2xULN or low volume disease and CA-125 > ULN.
Duration of recruitment: Anticipated recruitment for the trial is 3 years and 6 months. 
Aim
To assess the effectiveness of TroVax® in extending time to progression in asymptomatic relapsed ovarian cancer patients.
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
University College London, Gower Street, London, WC1E 6BT +44 (0)20 7679 2000

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