UKCCCR Randomised Trial of Adjuvant Hormone Therapy (AHT) in Ovarian Cancer
| ISRCTN | ISRCTN71318684 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN71318684 |
| Secondary identifying numbers | ICR/AHT |
- Submission date
- 19/08/2002
- Registration date
- 19/08/2002
- Last edited
- 24/10/2019
- 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
Contact information
Dr - -
Scientific
Scientific
UKCCCR Register Co-ordinator
MRC Clinical Trials Unit
222 Euston Road
London
NW1 2DA
United Kingdom
Study information
| Study design | Randomised controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| 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 |
| Pharmaceutical study type(s) | |
| Phase | Not Applicable |
| Drug / device / biological / vaccine name(s) | Hormone therapy |
| Primary outcome measure | Not provided at time of registration |
| Secondary outcome measures | Not provided at time of registration |
| Overall study start date | 01/01/1990 |
| Completion date | 30/11/1995 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Not Specified |
| Sex | Female |
| Target number of participants | Not provided at time of registration |
| 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 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
MRC Clinical Trials Unit
London
NW1 2DA
United Kingdom
NW1 2DA
United Kingdom
Sponsor information
UK Co-ordinating Committee for Cancer Research (UKCCCR)
Government
Government
MRC Clinical Trials Unit
222 Euston Road
London
NW1 2DA
United Kingdom
"ROR" |
https://ror.org/054225q67 |
|---|
Funders
Funder type
Research organisation
Cancer organisations (UK)
No information available
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 | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 10/12/2015 | 24/10/2019 | Yes | No |
Editorial Notes
24/10/2019: Publication reference added.
