Condition category
Cancer
Date applied
23/11/2005
Date assigned
25/01/2006
Last edited
26/05/2015
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

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 measures

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

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

Results - basic reporting

Publication summary

2015 results in: http://www.ncbi.nlm.nih.gov/pubmed/26002111

Publication citations

Additional files

Editorial Notes