Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
ICR/AHT
Study information
Scientific title
UKCCCR Randomised Trial of Adjuvant Hormone Therapy (AHT) in Ovarian Cancer
Acronym
Study hypothesis
Not provided at time of registration
Ethics approval
Not provided at time of registration
Study design
Randomised controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Condition
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 names
Hormone therapy
Primary outcome measure
Not provided at time of registration
Secondary outcome measures
Not provided at time of registration
Overall trial start date
01/01/1990
Overall trial end date
30/11/1995
Reason abandoned (if study stopped)
Eligibility
Participant 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
Participant type
Patient
Age group
Not Specified
Gender
Female
Target number of participants
Not provided at time of registration
Participant exclusion criteria
Patients for whom ovarian function has been deliberately preserved are excluded
Recruitment start date
01/01/1990
Recruitment end date
30/11/1995
Locations
Countries of recruitment
United Kingdom
Trial participating centre
MRC Clinical Trials Unit
London
NW1 2DA
United Kingdom
Funders
Funder type
Research organisation
Funder name
Cancer organisations (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
Basic results (scientific)
Publication list
2015 results in: https://www.ncbi.nlm.nih.gov/pubmed/26417001 (added 24/10/2019)