An international, five-arm randomised trial of carboplatin and paclitaxel versus triplet or sequential doublet combination in patients with epithelial ovarian cancer or primary peritoneal carcinoma

ISRCTN	ISRCTN41636183
DOI	https://doi.org/10.1186/ISRCTN41636183
ClinicalTrials.gov number	NCT00011986
Secondary identifying numbers	E164/58

Submission date: 18/05/2001
Registration date: 18/05/2001
Last edited: 22/10/2018

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

Not provided at time of registration

Study website

Contact information

Dr P Harper
Scientific

Medical Oncology
3rd Floor Thomas Guy House
Guy's Hospital
St Thomas Street
London
SE1 9RT
United Kingdom

Email	abc@123.com

Study information

Study design	Randomised controlled trial
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Not specified
Study type	Treatment
Scientific title	An international, five-arm randomised trial of carboplatin and paclitaxel versus triplet or sequential doublet combination in patients with epithelial ovarian cancer or primary peritoneal carcinoma
Study acronym	ICON5/GOG182
Study objectives	To evaluate a variety of chemotherapy regimes for patients with advanced stage (FIGO III-IV) epithelial ovarian or serious primary peritoneal carcinoma. Efficacy will be determined through analysis of overall survival and progression free survival. The trial will also compare the toxicities and adverse effects of each treatment regimen, describe the dose density and collative dose delivery for each regime, compare response rates in patients with measurable disease. In the UK, evaluate the impact of regimes on quality of life, evaluate the impact of regimes on resource use and quality-adjusted life-years, collect and store genetic material for future studies of molecular genetics. The trial includes two stages, at the end of the first stage only those treatment arms that appear promising on the basis of progression free survival will continue in to the second stage which aims to evaluate the impact of the regimes on overall survival.
Ethics approval(s)	Not provided at time of registration
Health condition(s) or problem(s) studied	Ovarian cancer and peritoneal carcinoma
Intervention	Arm I: Taxol 175 mg/m^2 day one, Carboplatin AUC6 or AUC(EDTA)5 iv day one, eight cycles Arm II: Taxol 175 mg/m^2, day one, Gemzar 800 mg/m^2 days one and eight, Carboplatin AUC5 or AUC(EDTA)4, day one, eight cycles Arm III: Taxol 175 mg/m^2 day one, Caelyx 30 mg/m^2 day one every other cycle, Carboplatin AUC5 or AUC(EDTA)4 day one, eight cycles Arm IV: Hycamtin 1.25 mg/m^2 days one, two and three, Carboplatin AUC5 or AUC(EDTA)4 day three, four cycles, then four cycles of Arm I Arm V: Gemzar 1000 mg/m^2, days one and eight, Carboplatin AUC6 or AUC(EDTA)5 day eight, four cycles then four cycles of Arm I In every case cycles are 21 days long. Chemotherapy continues unless disease progression or unacceptable toxicity occurs. Dose reductions or delays for toxicity are defined in the full protocol.
Intervention type	Drug
Pharmaceutical study type(s)
Phase	Not Applicable
Drug / device / biological / vaccine name(s)	Carboplatin and paclitaxel
Primary outcome measure	Overall survival.
Secondary outcome measures	1. Progression free survival 2. Response rate (in patients with measurable disease) 3. Toxicity and symptoms 4. Dose and dose intensity 5. Patients assessment of quality of life and acceptability of treatment, health economics 6. Molecular genetics (future study)
Overall study start date	01/03/2002
Completion date	31/12/2007

Eligibility

Participant type(s)	Patient
Age group	Adult
Sex	Both
Target number of participants	4000
Key inclusion criteria	1. Stage III or IV ovarian or serious primary peritoneal carcinoma, following appropriate surgery 2. Tumor tissue available for histological evaluation 3. Adequate bone marrow liver kidney and neurological function 4. World Health Organisation (WHO) performance status zero to two 5. Fit and able to take part in trial treatments and follow-up 6. Informed consent
Key exclusion criteria	1. Concomitant or previous malignancies likely to interfere with protocol treatments 2. Patient has received radiotherapy or chemotherapy to any abdominal or pelvic tumour 3. Acute hepatitis, infection or Gastrointestinal bleeding 4. Women of childbearing age who will not use adequate contraception or are breastfeeding
Date of first enrolment	01/03/2002
Date of final enrolment	31/12/2007

Locations

Countries of recruitment

England
United Kingdom
United States of America

Study participating centre

Medical Oncology

London
SE1 9RT
United Kingdom

Sponsor information

Medical Research Council (MRC) (UK)
Research council

20 Park Crescent
London
W1B 1AL
United Kingdom

Phone	+44 (0)20 7636 5422
Email	clinical.trial@headoffice.mrc.ac.uk
Website	http://www.mrc.ac.uk

Funders

Funder type

Research council

Medical Research Council (MRC) (UK)
Government organisation / National government

Alternative name(s): Medical Research Council (United Kingdom), UK Medical Research Council, MRC
Location: United Kingdom

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

Study outputs

Output type	Details	Date created	Peer reviewed?	Patient-facing?
Plain English results			No	Yes
Results article	results:	01/08/2003	Yes	No
Results article	results:	20/03/2009	Yes	No

Editorial Notes

22/10/2018: Cancer Research UK lay results summary link added to Results (plain English)