Study of aromatase inhibitors in women with potentially hormone responsive recurrent/metastatic gynaecological cancers
| ISRCTN | ISRCTN43261139 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN43261139 |
| Secondary identifying numbers | ANZGOG0903 |
- Submission date
- 22/12/2011
- Registration date
- 12/01/2012
- Last edited
- 29/10/2020
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Cancer
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year
Plain English summary of protocol
Contact information
Dr Richard Edmondson
Scientific
Scientific
Northern Institute for Cancer Research
Newcastle University Medical School
Paul O'Gorman Building
Framlington Way
Newcastle upon Tyne
NE2 4HH
United Kingdom
Study information
| Study design | Single arm prospective phase II study |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Non 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 | Phase II study of Aromatase inhibitors in women with potentially hormone Responsive recurrent/metastatic Gynaecological Neoplasms (PARaGoN) |
| Study acronym | PARaGoN |
| Study objectives | Objective: Determine clinical benefit rate by the proportion of patients experiencing either stable disease or response within 3 months of commencing treatment. |
| Ethics approval(s) | NRES Committee North East - Newcastle & North Tyneside, 07 December 2011 ref: 11/NE/0214 |
| Health condition(s) or problem(s) studied | Hormone responsive recurrent/metastatic gynaecological neoplasms |
| Intervention | Patients will be eligible for the trial if they have hormone responsive recurrent /metastatic gynaecological cancer which is unlikely to be cured by standard treatment. To be considered for the trial the original tumour specimens will be re examined to ensure that they express the oestrogen receptor. Patient will give written informed consent before enrollment, following enrollment all patients will be given a standard dose of the oral aromatase inhibitor anastrazole of 1mg per day. Patients will stay on treatment until progression or until 5 years after enrollment, whichever is the sooner. |
| Intervention type | Other |
| Primary outcome measure | Clinical benefit rate determined by the proportion of patients experiencing either stable disease or response within 3 months of commencing treatment. This will be determined radiologically by RECIST v1.1 or CA125 of inhibin (depending on the specific tumour type). |
| Secondary outcome measures | Progression free survival: this will be determined radiologically by Response Evaluation Criteria in Solid tumours (RECIST v1.1) or CA125 tumour marker response or inhibin. 1. Response duration in each subgroup: this will be determined radiologically by RECIST v1.1 or CA125 or inhibin. 2. Quality of life (QOL): will be assessed in the study using EORTC QLQ-C30 core questionnaire and the Functional Assessment of Cancer Therapy Endocrine Symptoms subscale. 3.Toxicity :Proportion of patients experiencing grade 3 or 4 toxicities, adverse events will be graded according to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.0. |
| Overall study start date | 01/01/2011 |
| Completion date | 31/12/2016 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Female |
| Target number of participants | 350 |
| Key inclusion criteria | 1. Patient with recurrent or metastatic gynaecological cancer. The specific subgroups are outlined below. All patients will have central review and analyses of oestrogen receptor/progesterone receptor (ER/PR) at a later date to confirm receptor status but entry to the study will be based on local hormone receptor analyses. 1.1. Epithelial ovarian cancer, primary peritoneal cancers and cancers of the fallopian fube 1.2. Endometrial cancer: patients that have measurable disease 1.3. Endometrial stromal sarcomas: patients that have measurable disease 1.4. Miscellaneous sarcomas: includes leimyosarcomas, adenosarcomas, carcinoasrcomas and undifferentiated sarcomas which have relapsed following standard treatment such as chemotherapy or patients in whom chemotherapy is not considered appropriate. 1.5. Granulosa cell tumours and other sex cord tumours: patients with measurable disease and/or elevated inhibin (total inhibin and/or inhibin B? level 1.6. UK centres will only enter patients to subgroups B-E of the study 2. All patients must have ER and/or PR positive tumours by immunohistochemical evaluation based on the assessment at individual sites. Hormone receptor staining should be carried out on the original tumour. If not available, but the recurrent tumour is receptor positive, then these patients will be eligible. 3. Post menopausal as defined by: 3.1. Aged 60 or more, or 3.2. Age 45-59 and has amenorrhoea for at least 12 months and follicle-stimulating hormone (FSH) in postmenopausal range with an intact uterus, or having had a bilateral oophorectomy 4. Evaluable disease defined as 4.1. Measurable disease as per Response Evaluation Criteria In Solid Tumours (RECIST) v1.1, or 4.2. Cancer antigen 125 (CA125) as per GCIG criteria (for ovarian cancer subgroup) or 4.3. Elevated total inhibin and/or inhibin B (for granulosa cell sub-group) 5. Eastern Cooperative Oncology Group (ECOG) peformance status 0-2 6. Expected survival > 3 months |
| Key exclusion criteria | Prior therapy with an aromatase inhibitor: 1. Patients receiving any hormone replacement therapy 2. Inability to comply with study procedures 3. Unable to give informed consent 4. Other active malignancy or primary malignancy diagnosed within the previous 5 years, except for treated squamous or basal cell carcinoma of skin or cervical carcinoma 5. Significant hepatic (bilirubin >2xULN) or renal dysfunction (creatinine>3x ULN) |
| Date of first enrolment | 01/01/2011 |
| Date of final enrolment | 31/12/2016 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
Northern Institute for Cancer Research
Newcastle upon Tyne
NE2 4HH
United Kingdom
NE2 4HH
United Kingdom
Sponsor information
NHS Greater Glasgow and Clyde (UK)
Hospital/treatment centre
Hospital/treatment centre
Research and Development
The Tennent Institute
Western Infirmary
38 Church Street
Glasgow
G11 6NT
Scotland
United Kingdom
| Website | http://www.nhsggc.org.uk/ |
|---|---|
"ROR" |
https://ror.org/05kdz4d87 |
Funders
Funder type
Charity
Cancer Research UK (UK) ref: A12846
Private sector organisation / Other non-profit organizations
Private sector organisation / Other non-profit organizations
- Alternative name(s)
- CR_UK, Cancer Research UK - London, CRUK
- Location
- United Kingdom
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? |
|---|---|---|---|---|---|
| Plain English results | 29/10/2020 | No | Yes | ||
| HRA research summary | 28/06/2023 | No | No |
Editorial Notes
29/10/2020: Added link to results (plain English).
