ANZCTR - Registration

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Trial registered on ANZCTR

Registration number

ACTRN12610000796088

Ethics application status

Approved

Date submitted

21/09/2010

Date registered

24/09/2010

Date last updated

27/10/2021

Date data sharing statement initially provided

10/05/2019

Date results provided

10/05/2019

Type of registration

Prospectively registered

Titles & IDs

Public title

Phase II study of aromatase inhibitors in women with potentially hormone responsive recurrent/metastatic gynaecological neoplasms

Scientific title

Phase II study of aromatase inhibitors in women with potentially hormone responsive recurrent/metastatic gynaecological neoplasms

Secondary ID [1]

ANZGOG 0903 (Australia New Zealand Gynaecological Oncology Group)

Universal Trial Number (UTN)

Trial acronym

PARAGON

Linked study record

Health condition

Health condition(s) or problem(s) studied:

Hormone sensitive recurrent or metastatic gynecological cancers

Condition category

Condition code

Cancer

Ovarian and primary peritoneal

Cancer

Womb (Uterine or endometrial cancer)

Intervention/exposure

Study type

Interventional

Description of intervention(s) / exposure

Registered patients are prescribed a 1mg Anastrazole (Armidex) tablet daily (orally) until disease progression

Intervention code [1]

Treatment: Drugs

Comparator / control treatment

There is no control group for this trial

Control group

Uncontrolled

Outcomes

Primary outcome [1]

Overall response to treatment as determined by Response Evaluation Criteria In Solid Tumors (RECIST) V1.1 criteria (all tumor sub-groups) or CA125 tumour marker response by Rustin criteria (ovarian sub-group) or inhibin (granulosa cell sub-group) as assessed at each visit by the Clinician

Timepoint [1]

Assessed monthly for the first 3 months on trial then every 3 months until disease progression

Secondary outcome [1]

Response to treatment in each tumor sub-group as determined by RECIST V1.1 criteria (all tumor sub-groups) or CA125 tumour marker response by Rustin criteria (ovarian sub-group) or inhibin (granulosa cell sub-group) as assessed at each visit by the Clinician

Timepoint [1]

Assessed monthly for the first 3 months on trial then every 3 months until disease progression

Secondary outcome [2]

Clinical benefit (complete response, partial response and stable disease) in those with measurable disease as determined by RECIST V1.1 criteria (all tumor sub-groups) or CA125 tumour marker response by Rustin criteria (ovarian sub-group) or inhibin (granulosa cell sub-group) as assessed at each visit by the Clinician

Timepoint [2]

Assessed monthly for the first 3 months on trial then every 3 months until disease progression

Secondary outcome [3]

Time to progression in patients without measureable disease as determined by RECIST V1.1 criteria (all tumor sub-groups) or CA125 tumour marker response by Rustin criteria (ovarian sub-group) or inhibin (granulosa cell sub-group) as assessed at each visit by the Clinician

Timepoint [3]

Assessed monthly for the first 3 months on trial then every 3 months until disease progression

Secondary outcome [4]

Time to response as determined by RECIST V1.1 criteria (all tumor sub-groups) or CA125 tumour marker response by Rustin criteria (ovarian sub-group) or inhibin (granulosa cell sub-group) as assessed at each visit by the Clinician

Timepoint [4]

Assessed monthly for the first 3 months on trial then every 3 months until disease progression

Secondary outcome [5]

Response duration as determined by RECIST V1.1 criteria (all tumor sub-groups) or CA125 tumour marker response by Rustin criteria (ovarian sub-group) or inhibin (granulosa cell sub-group) as assessed at each visit by the Clinician

Timepoint [5]

Assessed monthly for the first 3 months on trial then every 3 months until disease progression

Secondary outcome [6]

Quality of life as determined by Questionnaries

Timepoint [6]

Quality of life will be assessed upon registration, monthly for the first 3 months on trial and then every 3 months until disease progression

Secondary outcome [7]

Toxicity profile (including bone density) as detemined by a Bone mineral density scan (DXA) and blood tests

Timepoint [7]

Toxicity profile will be assessed upon registration and then monthly for the first 3 months on trial

Secondary outcome [8]

Maintain a register of these tumours and document the number of patients screened at participating sites and the percentage with Estrogen Receptor (ER)/Progesterone Receptor (PR) +ve tumours who are enrolled

Timepoint [8]

Upon registration

Secondary outcome [9]

Translational sub-study to correlate response rates with hormone receptor positivity as well as other biological markers that might predict for hormone response

Timepoint [9]

After registration

Eligibility

Key inclusion criteria

Patients with recurrent or metastatic gynaecological cancers. The specific subgroups are outlined below. All patients will have central review and analyses of ER/PR at a later date to confirm receptor status, but entry to the study will be based on hormone receptor positivity according to local hormone receptor analyses.
A. Epithelial Ovarian Cancer, Primary Peritoneal Cancers and Cancers of the Fallopian Tube
(i) Asymptomatic patients with a rising CA125 after first line chemotherapy and GCIG defined CA125 progression (these patients should either have no measureable disease or small volume recurrence and the expectation they would not require chemotherapy within the next 12 weeks)
(ii) Borderline ovarian tumours, micro-invasive ovarian tumours and well differentiated low grade ovarian cancers. Apart from surgery, treatment options are very limited for these patients as these tumours are usually chemotherapy resistant but are also relatively indolent
(iii) Platinum resistant or refractory ovarian, fallopian tube and primary peritoneal cancer in patients in whom further chemotherapy is not indicated
B. Endometrial Cancer – patients that have measurable disease
C. Endometrial Stromal Sarcomas: patients that have measurable disease
D. Miscellaneous Sarcomas: Includes leiomyosarcomas, adenosarcomas, carcinosarcomas and undifferentiated uterine sarcomas with measurable disease and relapse following standard treatment such as chemotherapy or patients in whom chemotherapy is not clinically indicated.
E. Granulosa Cell Tumours and other Sex Cord Stromal Tumours: patients that have measurable disease and/or an elevated inhibin (total inhibin and/or inhibin B) level and in whom chemotherapy is not clinically indicated

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 hormone receptor positive, then these patients will also be eligible

Post-menopausal as defined by: (i) age 60 or more, or (ii) age 45–59 and satisfying the following criteria: Amenorrhoea for at least 12 months and FSH in postmenopausal range with an intact uterus, or (iii) age equal to 18 or more and having had a bilateral oophorectomy

Evaluable disease defined as; (i) measurable disease as per RECIST v1.1, OR (ii) CA125 as per GCIG criteria (for ovarian cancer subgroup) OR (iii) elevated total inhibin and/or inhibin B (for granulosa cell sub-group)

ECOG Performance status 0-2

Expected survival > 3months

Minimum age

18 Years

Maximum age

No limit

Sex

Females

Can healthy volunteers participate?

No

Key exclusion criteria

Prior therapy with an aromatase inhibitor, tamoxifen or progestagens

Patients receiving any hormone replacement therapy

Inability to comply with study procedures

Unable to give informed consent

Other active malignancy or primary malignancy diagnosed within the previous 5 years, except for treated squamous or basal cell carcinoma of skin or in situ cervical carcinoma

Significant hepatic (bilirubin >2x ULN) or renal dysfunction (creatinine >3x ULN)

Study design

Purpose of the study

Treatment

Allocation to intervention

Non-randomised trial

Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)

Patients can be registered for the trial by faxing an enrolment form to the National Health and Medical Reseach Council (NHMRC) Clinical Trials Centre. There is no control group so all patients are treated with the same type and amount of study drug

Methods used to generate the sequence in which subjects will be randomised (sequence generation)

Masking / blinding

Open (masking not used)

Who is / are masked / blinded?

Intervention assignment

Single group

Other design features

Phase

Phase 2

Type of endpoint/s

Efficacy

Statistical methods / analysis

Recruitment

Recruitment status

Completed

Date of first participant enrolment

Anticipated

1/08/2011

Actual

11/01/2012

Date of last participant enrolment

Anticipated

Actual

28/06/2016

Date of last data collection

Anticipated

30/06/2020

Actual

30/04/2020

Sample size

Target

350

Accrual to date

Final

333

Recruitment in Australia

Recruitment state(s)

NSW,QLD,TAS,VIC

Recruitment outside Australia

Country [1]

United Kingdom

State/province [1]

Newcastle

Country [2]

New Zealand

State/province [2]

Country [3]

Belgium

State/province [3]

UZ Leuven

Funding & Sponsors

Funding source category [1]

Government body

Name [1]

Cancer Australia

Address [1]

Level 1, 16 Marcus Clarke Street
Canberra ACT 2601

PO Box 1201 Dickson
Canberra ACT 2602

Country [1]

Australia

Primary sponsor type

University

Name

University of Sydney

Address

NHMRC Clinical Trials Centre
The University of Sydney
Locked Bag 77
Camperdown NSW 1450

Country

Australia

Secondary sponsor category [1]

None

Name [1]

Address [1]

Country [1]

Other collaborator category [1]

Charities/Societies/Foundations

Name [1]

Australia New Zealand Gynaecological Oncology Group (ANZGOG

Address [1]

Australia New Zealand Gynaecological Oncology Group
Level 6, Chris O'Brien Lifehouse
119-143 Missenden Road
CAMPERDOWN NSW 2050

Country [1]

Australia

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

Sydney Local Health District (RPAH Zone) Ethics Review Committee

Ethics committee address [1]

Research Ethics and Governance Office (REGO)
RPAH Medical Centre
Suite 210A,  Level 2
100 Carillon Avenue
NEWTOWN NSW 2042

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

08/11/2010

Approval date [1]

12/07/2013

Ethics approval number [1]

Summary

Brief summary

There is compelling evidence to support a study of aromatase inhibitors in selected patients with potentially hormone sensitive recurrent or metastatic gynecological cancers. Hormonal therapy is an attractive option in patients with recurrent gynecological cancers where the objective of treatment is palliation and prolongation of survival rather than cure.  Aromatase inhibitors are generally well tolerated and in contrast to chemotherapy can be administered for prolonged periods with relatively little cumulative toxicity. The degree of activity and response rates reported in previous studies has varied considerably. This variability almost certainly reflects the heterogeneous populations treated, which have included women with advanced chemotherapy and hormone resistant tumours and those with a poor performance status where response rates are generally low. There is a clear need to investigate the role of hormonal therapies, particularly AIs, in women with potentially hormone responsive recurrent gynaecological cancers. Studies are required to establish the response rates, clinical benefit and quality of life as well as to identify predictors of response.

Trial website

Trial related presentations / publications

Public notes

Contacts

Principal investigator

Name

Prof Michael Friedlander

Address

Prince of Wales Hospital
Medical Oncology Clinical Trials Unit
Level 2, High St,
Randwick, NSW, 2031

Country

Australia

Phone

+61 2 9282 2606

Fax

Email

Michael.Friedlander@health.nsw.gov.au

Contact person for public queries

Name

PARAGON Trial Coordinator

Address

NHMRC CTC
Locked Bag 77
Camperdown NSW 1450

Country

Australia

Phone

+61 2 9562 5000

Fax

+61 2 9562 5094

Email

paragon@ctc.usyd.edu.au

Contact person for scientific queries

Name

Professor Michael Friedlander

Address

Prince of Wales Hospital High Street, Randwick NSW 2031

Country

Australia

Phone

+61 2 9282 2606

Fax

+61 2 9382 2588

Email

Michael.Friedlander@health.nsw.gov.au

Data sharing statement

Will individual participant data (IPD) for this trial be available (including data dictionaries)?

No

No/undecided IPD sharing reason/comment

What supporting documents are/will be available?

No Supporting Document Provided

Results publications and other study-related documents

Documents added manually

No documents have been uploaded by study researchers.

Documents added automatically

Source	Title	Year of Publication	DOI
Embase	Paragon (ANZGOG-0903): Phase 2 study of anastrozole in women with estrogen or progesterone receptorypositive platinum-resistant or -refractory recurrent ovarian cancer.	2017	https://dx.doi.org/10.1097/IGC.0000000000000978
Embase	PARAGON (ANZGOG-0903): A phase 2 study of anastrozole in asymptomatic patients with estrogen and progesterone receptor-positive recurrent ovarian cancer and CA125 progression.	2019	https://dx.doi.org/10.3802/jgo.2019.30.e86
Embase	Phase 2 study of anastrozole in recurrent estrogen (ER)/progesterone (PR) positive endometrial cancer: The PARAGON trial - ANZGOG 0903.	2019	https://dx.doi.org/10.1016/j.ygyno.2019.05.007
Embase	A phase 2 study of anastrozole in patients with oestrogen receptor and/progesterone receptor positive recurrent/metastatic granulosa cell tumours/sex-cord stromal tumours of the ovary: The PARAGON/ANZGOG 0903 trial.	2021	https://dx.doi.org/10.1016/j.ygyno.2021.07.024
Embase	Phase 2 study of anastrozole in patients with estrogen receptor/progesterone receptor positive recurrent low-grade endometrial stromal sarcomas: The PARAGON trial (ANZGOG 0903).	2021	https://dx.doi.org/10.1016/j.ygyno.2021.02.016
Embase	Phase 2 study of anastrozole in rare cohorts of patients with estrogen receptor/progesterone receptor positive leiomyosarcomas and carcinosarcomas of the uterine corpus: The PARAGON trial (ANZGOG 0903).	2021	https://dx.doi.org/10.1016/j.ygyno.2021.09.010
Embase	Update on new treatments for rare ovarian tumours.	2023	https://dx.doi.org/10.1097/GCO.0000000000000836

N.B. These documents automatically identified may not have been verified by the study sponsor.