ANZCTR - Registration

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Trial registered on ANZCTR

Registration number

ACTRN12625000751471

Ethics application status

Approved

Date submitted

7/06/2025

Date registered

16/07/2025

Date last updated

16/07/2025

Date data sharing statement initially provided

16/07/2025

Type of registration

Prospectively registered

Titles & IDs

Public title

Quality of life and adherence to post-operative thromboprophylaxis following surgery for gynaecological cancers: rivaroxaban vs low molecular weight heparin – The Gynaecology Oncology RivarOXaban acceptability study

Scientific title

Secondary ID [1]

RO#24260

Universal Trial Number (UTN)

Trial acronym

GOROX acceptability study

Linked study record

Health condition

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

Venous thromboembolism prophylaxis

Surgery for gynaecological cancers

Condition category

Condition code

Blood

Clotting disorders

Cancer

Other cancer types

Cancer

Cervical (cervix)

Cancer

Ovarian and primary peritoneal

Cancer

Womb (Uterine or endometrial cancer)

Intervention/exposure

Study type

Interventional

Description of intervention(s) / exposure

Rivaroxaban 10mg oral once daily. This will be initiated at the treating doctor’s discretion on day 1-3 post-operatively and continued until day 28 post op
Patients will complete a medication adherence diary

Intervention code [1]

Treatment: Drugs

Comparator / control treatment

Enoxaparin 40mg subcutaneous once daily which is the current standard of care
This starts immediately post op and continues for 28 doses
Patients will complete a medication adherence diary

Control group

Active

Outcomes

Primary outcome [1]

Quality of life

Timepoint [1]

SF-8 questionnaire will be assessed at baseline (pre-surgery) and day 28 post-surgery

Primary outcome [2]

Treatment satisfaction

Timepoint [2]

Day 28 post-surgery

Secondary outcome [1]

To evaluate medication adherence rates of rivaroxaban compared to enoxaparin in a similar setting

Timepoint [1]

From day 1 to day 28 post surgery patients will fill out a medication adherence diary

Secondary outcome [2]

Incidence of symptomatic venous thromboembolism (VTE)

Timepoint [2]

Post-operation visit (Day 12) and end-of-study phone call (Day 28 post-surgery)

Secondary outcome [3]

Incidence of major and clinically relevant non-major bleeding, this will be assessed as a composite outcome

Timepoint [3]

Post-operation visit (Day 12) and end-of-study phone call (Day 28 post-surgery)

Eligibility

Key inclusion criteria

Suspected or known diagnosis of an abdominal or pelvic malignancy (regardless of stage)

Scheduled for elective abdominal surgery (either laparotomy or laparoscopy) and who would routinely be discharged with prophylactic dose enoxaparin for 28 days.

Minimum age

18 Years

Maximum age

89 Years

Sex

Females

Can healthy volunteers participate?

Key exclusion criteria

- Elective surgery for known benign disease
- Surgery for vulvar malignancies
- High risk for bleeding (not limited to thrombocytopenia, hemophilia’s, potential bleeding lesions, recent trauma, recent stroke, confirmed intracranial or intraspinal bleeding)
- Contraindications for anticoagulant treatment, renal disease (Crcl< 50mls/min)
- Liver disease i.e. AST and ALT twice the normal, liver failure, chronic active hepatitis, liver cirrhosis
- Known history of VTE
- Patients already on anti-coagulation preoperatively
- History of disorders that predispose to hypercoagulability i.e. Factor V Leiden homozygotes or antithrombin deficiency
- History of heparin induced thrombocytopenia
- Concomitant use of other anti-coagulants or antiplatelet therapy
- With prosthetic heart valves
- Uncontrolled severe hypertension (systolic >200mmHg or diastolic >120 mmHg)
- <18 years old
- Pregnancy or lactation
- Unable to provide informed consent
- Documented allergy to rivaroxaban or LMWH.
- Patients deemed otherwise clinically unfit for clinical trial per investigator’s discretion
- Concomitant use of any of the following medications: ketoconazole, rifampicin, carbamazepine and phenytoin, itraconazole, erythromycin, azithromycin, St John’s Wort

Study design

Purpose of the study

Prevention

Allocation to intervention

Randomised controlled trial

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

Central randomisation by REDCap

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

1:1 randomisation using compute software with block randomisation used to equally distribute treatment assignments for surgical intervention groups (minimally invasive versus open surgery).

Masking / blinding

Open (masking not used)

Who is / are masked / blinded?

Intervention assignment

Other design features

Phase

Phase 4

Type of endpoint/s

Statistical methods / analysis

Recruitment

Recruitment status

Not yet recruiting

Date of first participant enrolment

Anticipated

1/12/2025

Actual

Date of last participant enrolment

Anticipated

1/04/2026

Actual

Date of last data collection

Anticipated

1/05/2026

Actual

Sample size

Target

Accrual to date

Final

Recruitment outside Australia

Country [1]

New Zealand

State/province [1]

Funding & Sponsors

Funding source category [1]

Charities/Societies/Foundations

Name [1]

ANZGOG FFNR grant

Address [1]

Country [1]

Australia

Primary sponsor type

Government body

Name

Health NZ Waitaha

Address

Country

New Zealand

Secondary sponsor category [1]

None

Name [1]

Address [1]

Country [1]

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

Southern Health and Disability Ethics Committee

Ethics committee address [1]

https://ethics.health.govt.nz/about/southern-health-and-disability-ethics-committee/

Ethics committee country [1]

New Zealand

Date submitted for ethics approval [1]

22/06/2025

Approval date [1]

08/07/2025

Ethics approval number [1]

21981, Provisional approval currently

Summary

Brief summary

Current guidelines indicate that after major surgeries for gynaecology cancers, 28 days of blood thinning medication injected under the skin is recommended to reduce the risk of blood clots in the lungs and legs. This can cause bruising and localised pain and impacts whether patients continue taking the medication or not. One study in orthopaedic patients has shown that an oral medication may be effective as an alternative in preventing blood clots instead and because orthopaedic patients and gynae-oncology patients have similar patient characteristics, we believe that this oral medication called rivaroxaban could be suitable for our patients. 

This study wants to see how the current different treatment options impact patient’s quality of life and how closely they stick with taking the medication. The expected outcome is that patients will prefer the oral medication as this is less likely to produce side effects and so patients will be more likely to continue to take the medication also.

We hope that this will have a positive impact on patient's recovery from surgery in the future and if more patients take the medication, an overall lower risk of blood clots.

Trial website

Trial related presentations / publications

Public notes

Contacts

Principal investigator

Name

Dr Bryony Simcock

Address

Christchurch Women's Hospital, 2 Riccarton Avenue, Christchurch Central, 8011, Christchurch

Country

New Zealand

Phone

+6473826597

Fax

[email protected]

Contact person for public queries

Name

Faye Riley

Address

Christchurch Women's Hospital, 2 Riccarton Avenue, Christchurch Central, 8011, Christchurch

Country

New Zealand

Phone

+64223154163

Fax

[email protected]

Contact person for scientific queries

Name

Bryony Simcock

Address

Christchurch Women's Hospital, 2 Riccarton Avenue, Christchurch Central, 8011, Christchurch

Country

New Zealand

Phone

+6473826597

Fax

[email protected]

Data sharing statement

Will the study consider sharing individual participant data?

Yes

Will there be any conditions when requesting access to individual participant data?

Persons/groups eligible to request access:
• Researchers
Conditions for requesting access:
• Yes, conditions apply:
• Requires approval by an ethics committee
• Requires a data sharing agreement between data requester and trial custodian or sponsor

What individual participant data might be shared?

• All de-identified individual participant data

What types of analyses could be done with individual participant data?

• Systematic reviews and meta-analyses
• Studies exploring new research questions
• Health economic analyses

When can requests for individual participant data be made (start and end dates)?

From:
At the end of the study
To:
A finite period of: 10 years

Where can requests to access individual participant data be made, or data be obtained directly?

• Email of trial custodian, sponsor or committee: [email protected]

Are there extra considerations when requesting access to individual participant data?

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

No additional documents have been identified.

Trial Review

Documents added manually

Documents added automatically