Study of aromatase inhibitors in women with potentially hormone responsive recurrent/metastatic gynaecological cancers

ISRCTN	ISRCTN43261139
DOI	https://doi.org/10.1186/ISRCTN43261139
Protocol serial number	ANZGOG0903
Sponsor	NHS Greater Glasgow and Clyde (UK)
Funder	Cancer Research UK (UK) ref: A12846

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

https://www.cancerresearchuk.org/about-cancer/find-a-clinical-trial/a-trial-anastrozole-hormone-receptor-positive-gynaecological-cancers-paragon

Contact information

Dr Richard Edmondson
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

Primary study design	Interventional
Study design	Single arm prospective phase II study
Secondary study design	Non randomised controlled trial
Study type	Participant 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(s)	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).
Key secondary outcome measure(s)	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.
Completion date	31/12/2016

Eligibility

Participant type(s)	Patient
Age group	Adult
Sex	Female
Target sample size at registration	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

United Kingdom
England

Study participating centre

Northern Institute for Cancer Research

Newcastle upon Tyne
NE2 4HH
United Kingdom

Results and Publications

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary
IPD sharing plan

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
HRA research summary			28/06/2023	No	No
Participant information sheet	Participant information sheet	11/11/2025	11/11/2025	No	Yes
Plain English results			29/10/2020	No	Yes

Editorial Notes

29/10/2020: Added link to results (plain English).