UKCCCR Randomised Trial of Adjuvant Hormone Therapy (AHT) in Ovarian Cancer

ISRCTN	ISRCTN71318684
DOI	https://doi.org/10.1186/ISRCTN71318684
Protocol serial number	ICR/AHT
Sponsor	UK Co-ordinating Committee for Cancer Research (UKCCCR)
Funder	Cancer organisations (UK)

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

Primary study design	Interventional
Study design	Randomised controlled trial
Secondary study design	Randomised controlled trial
Scientific title	UKCCCR Randomised Trial of Adjuvant Hormone Therapy (AHT) in Ovarian Cancer
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. AHT Regimen: Adjuvant hormone therapy (AHT), type according to the preference of the patient's consultant, providing the prescribing practice is consistent. It is recommended that premenopausal women receive higher doses than peri- and postmenopausal women. Treatment to begin within 2 weeks of randomisation. AHT to be prescribed for a minimum of 5 years if tolerated. 2. Control Regimen: No treatment with AHT.
Intervention type	Drug
Phase	Not Applicable
Drug / device / biological / vaccine name(s)	Hormone therapy
Primary outcome measure(s)	Not provided at time of registration
Key secondary outcome measure(s)	Not provided at time of registration
Completion date	30/11/1995

Participant type(s)	Patient
Age group	Not Specified
Sex	Female
Key inclusion criteria	1. Histologically confirmed epithelial ovarian cancer diagnosed within the last 9 months 2. Pre and/or postmenopausal 3. Chemotherapy and radiotherapy may be given at the discretion of the participating clinician, provided it does not include hormonal treatment other than that allocated in the trial 4. No history of hormone dependent malignancy 5. No contraindications to AHT
Key exclusion criteria	Patients for whom ovarian function has been deliberately preserved are excluded
Date of first enrolment	01/01/1990
Date of final enrolment	30/11/1995

MRC Clinical Trials Unit

London
NW1 2DA
United Kingdom

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results	10/12/2015	24/10/2019	Yes	No

24/10/2019: Publication reference added.