Randomised study of two doses of cisplatin with cyclophosphamide in epithelial ovarian cancer

ISRCTN	ISRCTN78953383
DOI	https://doi.org/10.1186/ISRCTN78953383
Secondary identifying numbers	G31

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Dr - -
Scientific

UKCCCR Register Co-ordinator
MRC Clinical Trials Unit
222 Euston Road
London
NW1 2DA
United Kingdom

Study design	Randomised controlled trial
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Hospital
Study type	Treatment
Participant information sheet	Not available in web format, please use the contact details below to request a patient information sheet
Scientific title
Study objectives	Not provided at time of registration
Ethics approval(s)	Not provided at time of registration
Health condition(s) or problem(s) studied	Ovarian Cancer
Intervention	1. Group A: Cisplatin 50 mg/m2 plus 750 mg/m2 cyclophosphamide repeated every 3 weeks for a maximum of six cycles 2. Group B: Cisplatin 100 mg/m2 plus 750 mg/m2 cyclophosphamide repeated every 3 weeks for a maximum of six cycles
Intervention type	Other
Primary outcome measure	Not provided at time of registration
Secondary outcome measures	Not provided at time of registration
Overall study start date	01/01/1991
Completion date	01/03/1991

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Sex	Female
Target number of participants	Not provided at time of registration
Key inclusion criteria	1. Confirmed diagnosis of invasive epithelial ovarian carcinoma including the following histological subtypes: Serous cystadenocarcinoma; Mucinous cystadenocarcinoma; Endometriod carcinoma; Clear cell (mesonephroid) carcinoma; Undifferentiated carcinoma 2. International Federation of Gynecology and Obstetrics (FIGO) stage Ic, II, III and IV 3. Age 18 -70 years 4. Eastern Cooperative Oncology Group (ECOG) performance status 0-2 5. Life expectancy of at least 3 months 6. Adequate bone marrow and renal function 7. No previous chemotherapy or radiotherapy 8. No history of previous malignancy, except adequately treated basal cell carcinoma of the skin or in situ carcinoma of the cervix 9. No serious intercurrent disease
Key exclusion criteria	Does not match inclusion criteria
Date of first enrolment	01/01/1991
Date of final enrolment	01/03/1991

UKCCCR Register Co-ordinator

London
NW1 2DA
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	08/08/1992		Yes	No