Contact information
Type
Scientific
Primary contact
Prof Sean Kehoe
ORCID ID
Contact details
Nuffield Dept of Obstetrics and Gynaecology
John Radcliffe Hospital
Oxford
OX3 9DU
United Kingdom
+44 (0)1865 741166
sean.kehoe@obs-gyn.ox.ac.uk
Additional identifiers
EudraCT number
ClinicalTrials.gov number
NCT00075712
Protocol/serial number
N/A
Study information
Scientific title
A randomised feasibility trial to determine the impact of timing of surgery and chemotherapy in newly diagnosed patients with advanced epithelial ovarian, primary peritoneal, or fallopian tube carcinoma
Acronym
CHORUS
Study hypothesis
The aim of this trial is to assess the acceptability of this randomised trial to clinicians and patients. It is intended that between 100 and 150 patients be randomised over a period of 18 months. If this is achieved, a large phase III trial is planned to follow on from this feasibility trial. The aim of the phase III trial is to determine the impact of the timing of surgery and chemotherapy in patients with advanced epithelial ovarian, primary peritoneal, or fallopian tube cancer, in terms of survival, progression-free survival, and quality of life.
More details can be found at: http://www.ctu.mrc.ac.uk/research_areas/study_details.aspx?s=9
Ethics approval
Metropolitan Multi-centre Research Ethics Committee, 22/09/2003, ref: MREC03/11/058
Study design
Two-arm multi-centre randomised controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Patient information leaflet on page 22 of the protocol: http://www.ctu.mrc.ac.uk/studies/documents/protocol.pdf
Condition
Advanced epithelial ovarian, primary peritoneal or fallopian tube carcinoma
Intervention
Primary surgery arm (control):
This comprises radical surgery followed by 6 cycles of carboplatin-based chemotherapy at 3-weekly intervals. The interval between randomisation and the initiation of surgery should be a maximum of 4 weeks. Chemotherapy should commence within 6 weeks of primary surgery. Interval debulking surgery may be carried out at the discretion of the clinician if appropriate and if stated as the intention prior to randomisation; this should be carried out as close as possible to 3 weeks after the 3rd cycle of chemotherapy. Chemotherapy should be resumed within 6 weeks of interval debulking surgery.
Neoadjuvant chemotherapy arm:
This comprises histological or cytological confirmation of disease followed by 3 cycles of carboplatin-based chemotherapy at 3-weekly intervals. Neoadjuvant chemotherapy should be carried out within 4 weeks of randomisation. Surgery following neoadjuvant chemotherapy to be performed as close as possible to 3 weeks after the 3rd cycle of chemotherapy. A further 3 cycles of carboplatin-based chemotherapy should be given within 6 weeks of surgery.
Doses of chemotherapy regimens:
Paclitaxel and carboplatin combination:
Paclitaxel 175 mg/m2, Carboplatin 5 x (51Cr-EDTA or measured clearance + 25) mg or 6 x (calculated clearance + 25) mg repeated every 3 weeks for 6 cycles
Carboplatin as a single agent:
Carboplatin 6 x (51Cr-EDTA or measured clearance + 25) mg or 7 x (calculated clearance + 25) mg
The chemotherapy regimens chosen were based on results from the ICON3 trial.
Intervention type
Mixed
Phase
Drug names
Primary outcome measure
Overall survival
Secondary outcome measures
1. Progression-free survival
2. Quality of life
Overall trial start date
01/03/2004
Overall trial end date
30/08/2010
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
1. Clinical and imaging evidence of a pelvic mass with extrapelvic metastatic disease at presentation
2. Randomisation should be carried out within 4 weeks of obtaining clinical and imaging evidence of disease
3. Serum Cancer Antigen (CA 125) / CarcinoEmbryonic Antigen (CEA) ratio >25 (if the serum CA 125/CEA is less than or equal to 25 and the serum CEA is above the upper limit of normal, the patient should undergo investigations to exclude gastrointestinal cancer)
4. Patient planned to receive carboplatin-based chemotherapy
5. Patient fit to undergo protocol treatment and follow-up
6. No concomitant or previous malignancy likely to interfere with protocol treatments or comparisons
7. Written informed consent of the patient
Participant type
Patient
Age group
Adult
Gender
Female
Target number of participants
100-150
Participant exclusion criteria
N/A
Recruitment start date
01/03/2004
Recruitment end date
30/08/2010
Locations
Countries of recruitment
United Kingdom
Trial participating centre
Nuffield Dept of Obstetrics and Gynaecology
Oxford
OX3 9DU
United Kingdom
Sponsor information
Organisation
Medical Research Council (UK)
Sponsor details
c/o Dr Ian Viney
MRC Centre London
Stehenson House
158-160 North Gower Street
London
NW1 2DA
United Kingdom
+44 (0)20 7670 4625
iv@centre-london.mrc.ac.uk
Sponsor type
Research council
Website
Funders
Funder type
Research council
Funder name
Start up grant from Royal College of Obstetricians and Gynaecologists (RCOG; UK)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Funder name
Core funding from Medical Research Council Clinical Trials Unit (MRC CTU; UK)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Basic results (scientific)
Publication list
2015 results in: http://www.ncbi.nlm.nih.gov/pubmed/26002111