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

ISRCTN	ISRCTN74802813
DOI	https://doi.org/10.1186/ISRCTN74802813
ClinicalTrials.gov number	NCT00075712
Secondary identifying numbers	N/A

Submission date: 23/11/2005
Registration date: 25/01/2006
Last edited: 26/10/2022

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Cancer

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

https://www.cancerresearchuk.org/about-cancer/find-a-clinical-trial/a-trial-comparing-surgery-before-and-during-chemotherapy-for-ovarian-fallopian-tube-or-primary-peritoneal-cancer

Study website

Contact information

Prof Sean Kehoe
Scientific

Nuffield Dept of Obstetrics and Gynaecology
John Radcliffe Hospital
Oxford
OX3 9DU
United Kingdom

Phone	+44 (0)1865 741166
Email	sean.kehoe@obs-gyn.ox.ac.uk

Study information

Study design	Two-arm multi-centre randomised controlled trial
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Hospital
Study type	Treatment
Participant information sheet	Patient information leaflet on page 22 of the protocol: http://www.ctu.mrc.ac.uk/studies/documents/protocol.pdf
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
Study acronym	CHORUS
Study objectives	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(s)	Metropolitan Multi-centre Research Ethics Committee, 22/09/2003, ref: MREC03/11/058
Health condition(s) or problem(s) studied	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
Primary outcome measure	Overall survival
Secondary outcome measures	1. Progression-free survival 2. Quality of life
Overall study start date	01/03/2004
Completion date	30/08/2010

Eligibility

Participant type(s)	Patient
Age group	Adult
Sex	Female
Target number of participants	100-150
Total final enrolment	550
Key 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
Key exclusion criteria	N/A
Date of first enrolment	01/03/2004
Date of final enrolment	30/08/2010

Locations

Countries of recruitment

England
United Kingdom

Study participating centre

Nuffield Dept of Obstetrics and Gynaecology

Oxford
OX3 9DU
United Kingdom

Sponsor information

Medical Research Council (UK)
Research council

c/o Dr Ian Viney
MRC Centre London
Stehenson House
158-160 North Gower Street
London
NW1 2DA
United Kingdom

Phone	+44 (0)20 7670 4625
Email	iv@centre-london.mrc.ac.uk
"ROR"	https://ror.org/03x94j517

Funders

Funder type

Research council

Start up grant from Royal College of Obstetricians and Gynaecologists (RCOG; UK)

No information available

Core funding from Medical Research Council Clinical Trials Unit (MRC CTU; UK)

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
Publication and dissemination plan	Not provided at time of registration
IPD sharing plan	Not provided at time of registration

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results	18/07/2015		Yes	No
Plain English results			26/10/2022	No	Yes

Editorial Notes

25/10/2022: Cancer Research UK plain English results link and total final enrolment added.