A randomised study comparing carboplatin and carboplatin with thalidomide in patients with Stage Ic-IV Ovarian Cancer

ISRCTN	ISRCTN12694440
DOI	https://doi.org/10.1186/ISRCTN12694440
ClinicalTrials.gov number	NCT00004876
Secondary identifying numbers	96.084

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Dr TS Ganesan
Scientific

Oxford Radcliffe Hospital
Oxford
0X3 9DU
United Kingdom

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
Study objectives	Drugs used in chemotherapy use different ways to stop tumour cells from dividing so they stop growing or die. Thalidomide may stop the growth of ovarian cancer by stopping blood flow to the tumour. This randomised phase II trial is studying how well giving carboplatin together with thalidomide works compared to carboplatin alone in treating patients with ovarian epithelial cancer.
Ethics approval(s)	Not provided at time of registration
Health condition(s) or problem(s) studied	Ovarian cancer
Intervention	Patients entering the trial will be randomised to receive carboplatin (every 4 weeks for a maximum of six cycles) only or carboplatin with thalidomide (for 24 weeks commencing on the first day of carboplatin therapy and ceasing 4 weeks after the last cycle of chemotherapy).
Intervention type	Drug
Pharmaceutical study type(s)
Phase	Not Specified
Drug / device / biological / vaccine name(s)	Carboplatin, thalidomide
Primary outcome measure	1. Safety 2. Response 3. Markers of angiogenesis
Secondary outcome measures	No secondary outcome measures
Overall study start date	01/08/1999
Completion date	31/12/2005

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Sex	Female
Target number of participants	30
Key inclusion criteria	1. Histologically confirmed epithelial ovarian cancer 2. Post-menopausal or if pre-menopausal, patients must have had a bilateral salpingo-oophorectomy and/or a total abdominal hysterectomy 3. Stage Ic-IV ovarian cancer 4. Aged over 18 years 5. World Health Organisation (WHO) performance status 0, 1 or 2 6. Written informed consent 7. No previous carboplatin/cisplatin treatment for ovarian cancer 8. No other current invasive malignancy 9. Neither pregnant or with the ability to become pregnant 10. No chronic neurological disease causing peripheral neuropathy 11. No diabetes mellitus
Key exclusion criteria	Not provided at time of registration
Date of first enrolment	01/08/1999
Date of final enrolment	31/12/2005

Oxford Radcliffe Hospital

Oxford
0X3 9DU
United Kingdom

Cancer Research UK (CRUK) (UK)
Charity

PO Box 123
Lincoln's Inn Fields
London
WC2A 3PX
United Kingdom

Charity

Cancer Research UK (CRUK) (UK)
Private sector organisation / Other non-profit organizations

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

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results	01/08/2011		Yes	No