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Trial registered on ANZCTR


Registration number
ACTRN12610000732088
Ethics application status
Approved
Date submitted
24/08/2010
Date registered
2/09/2010
Date last updated
11/11/2020
Date data sharing statement initially provided
14/06/2019
Date results information initially provided
14/06/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
A Phase III trial of adjuvant chemotherapy following chemoradiation as primary treatment for locally advanced cervical cancer compared to chemoradiation alone
Scientific title
Does the addition of adjuvant chemotherapy to standard cisplatin-based chemoradiation improve overall survival in women with locally advanced cervical cancer?
Secondary ID [1] 251836 0
Australia New Zealand Gynaecological Oncology Group (ANZGOG) 0902
Universal Trial Number (UTN)
Trial acronym
The OUTBACK Trial
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Locally advanced cervical cancer 256735 0
Condition category
Condition code
Cancer 256889 256889 0 0
Cervical (cervix)

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Patients will be treated with standard external beam radiation treatment to the pelvis and brachytherapy. Cisplatin will be given intravenously during the radiation at a dose of 40mg/m2 weekly for 5 doses. Within 4 weeks of completion of all radiation treatment, including the brachytherapy component, and following recovery from toxicities, patients will be treated with 4 cycles of 3 weekly adjuvant chemotherapy using carboplatin (Area Under Curve (AUC) 5 and paclitaxel 155 mg/m2 intravenously. The chemotherapy is administered once every 3 weeks for 4 cycles. Both drugs are admistered simultaneously over 3 hours.
Intervention code [1] 255954 0
Treatment: Drugs
Comparator / control treatment
Patients will be treated with standard external beam radiation treatment to the pelvis and brachytherapy. Cisplatin will be given intravenously during the radiation at a dose of 40mg/m2 weekly for 5 doses. The control group does not receive any adjuvant chemotherapy.
Control group
Active

Outcomes
Primary outcome [1] 257762 0
Overall survival. Tools of assessment: patient medical records, follow-up visits
Timepoint [1] 257762 0
at 3 and 5 years following randomisation
Secondary outcome [1] 263148 0
Progression-free survival. Tools of assessment: Tumour Response Assessment after computer tomography (CT) or magnetic resonance imaging (MRI).
Timepoint [1] 263148 0
at 3 and 5 years following randomisation
Secondary outcome [2] 263149 0
Acute and long-term toxicities. Tools of assessment: Toxicity scoring reports
Timepoint [2] 263149 0
throughout the study (3 monthly for the first 2 years after randomisation, 6 monthly in years 3-5 after ranndomisation)
Secondary outcome [3] 263150 0
Patterns of disease recurrence. Tools of assessment: computer tomography (CT) or magnetic resonance imaging (MRI).
Timepoint [3] 263150 0
at 6 months post randomisation and then repeated if relapse clinically suspected until confirmed progression or end of folllow-up period at 5 years.
Secondary outcome [4] 263151 0
Patient quality of life, including psycho-sexual health. Tools of assessment: European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionaires, Functional Assessment of Chronic Therapy (FACT) questionnaire and Sexual Function -Vaginal Changes (SVQ) questionnaire.
Timepoint [4] 263151 0
at baseline, after each cycle of adjuvant chemotherapy, at the completion of all study treatment, 3 monthly for the first 2 years after randomisation and then 6 monthly in the 3rd year after randomsiation. No Quality of Life Questionaires will be required after that pointin time.

Eligibility
Key inclusion criteria
- Stages IB1 and positive nodes, IB2, II, IIIB or IVa cervical cancer suitable for primary treatment with chemoradiation with curative intent.
- Eastern Cooperative Oncology Group (ECOG) performance status 0-2
- Histological diagnosis of squamous cell carcinoma, adenocarcinoma or adenosquamous cell carcinoma of the cervix
- White Blood Cell (WBC) Count greater than or equal to 3.0 x 109/L and absolute neutrophil count (ANC) greater than or equal to 1.5 x 109/L
- Platelets greater than or equal to 100 x 109/L
- Bilirubin less than or equal to 1.5 x Upper limit of normal (ULN)
- Liver enzyme Asparate Amino Transferase (AST) or Amino Alanine Transferase (ALT) less than or equal to 2.5 x Upper limit of normal (ULN)
- Adequate renal function: calculated creatinine clearance (Cockcroft-Gault Formula) greater than or equal to 60ml/min or greater than or equal to 50 ml/min by Ethylenediaminetetraacetic acid (EDTA) creatinine clearance
- Written informed consent
Minimum age
18 Years
Maximum age
No limit
Gender
Females
Can healthy volunteers participate?
No
Key exclusion criteria
- Any previous pelvic radiotherapy
- Para-aortic nodal involvement above the level of the common iliac nodes or L3/L4 (if biopsy proven, positron emission tomography (PET) positive or greater than or equal to 15mm short axis diameter on computer tomography (CT)
- Patients with bilateral hydronephrosis unless at least one side has been stented and renal function fulfils the required inclusion criteria
- Previous chemotherapy for this tumour
- Stage IIIA disease
- Evidence of distant metastases
- Prior diagnosis of Crohn’s disease or ulcerative colitis
- Peripheral neuropathy > grade 2
- Patients who have undergone hysterectomy or will have a hysterectomy as part of their initial cervix cancer therapy
- Patients with other invasive malignancies, with the exception of non-melanoma skin cancer, who had (or have) any evidence of the other cancer present within the last 5 years
- Patients who are pregnant or lactating
- Any contraindication to the use of cisplatin, carboplatin or paclitaxel chemotherapy
- Serious illness or medical condition that precludes the safe administration of the trial treatment including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements
- Human immunodeficiency virus (HIV) positive

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Participants will be randomly allocated to one of the two groups through a web-based randomisation system. Allocation is concealed through central randomisation by computer.
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
Parallel
Other design features
Phase
Phase 3
Type of endpoint(s)
Safety/efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Active, not recruiting
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,VIC,QLD,SA,WA
Recruitment outside Australia
Country [1] 2456 0
Canada
State/province [1] 2456 0
Country [2] 2459 0
United States of America
State/province [2] 2459 0
Country [3] 2460 0
New Zealand
State/province [3] 2460 0
Country [4] 8013 0
China
State/province [4] 8013 0
Country [5] 8014 0
Singapore
State/province [5] 8014 0
Country [6] 8015 0
Saudi Arabia
State/province [6] 8015 0

Funding & Sponsors
Funding source category [1] 256548 0
Government body
Name [1] 256548 0
National Health & Medical Research Council
Address [1] 256548 0
National Health and Medical Research Council (NHMRC)
GPO Box 1421
Canberra ACT 2601
Country [1] 256548 0
Australia
Primary sponsor type
University
Name
The University of Sydney
Address
NHMRC Clinical Trials Centre
The University of Sydney
Locked Bag 77
Camperdown NSW 1450
Country
Australia
Secondary sponsor category [1] 255849 0
None
Name [1] 255849 0
Address [1] 255849 0
Nil
Country [1] 255849 0
Other collaborator category [1] 251501 0
Charities/Societies/Foundations
Name [1] 251501 0
Australia New Zealand Gynaecological Oncology Group (ANZGOG)
Address [1] 251501 0
ANZGOG Operations Team Level 6 Chris O'Brien Lifehouse 119-143 Missenden Road CAMPERDOWN NSW2050
Country [1] 251501 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 258509 0
Cancer Institute NSW
Ethics committee address [1] 258509 0
Clinical Research Ethics Committee
Cancer Institute NSW
PO Box 41
ALEXANDRIA NSW 1435
Ethics committee country [1] 258509 0
Australia
Date submitted for ethics approval [1] 258509 0
Approval date [1] 258509 0
17/08/2010
Ethics approval number [1] 258509 0
2010C/04/129
Ethics committee name [2] 295413 0
Sydney Local Health District
Ethics committee address [2] 295413 0
Level 11, KGV Building
Missenden Road
CAMPERDOWN NSW 2050
Ethics committee country [2] 295413 0
Australia
Date submitted for ethics approval [2] 295413 0
06/06/2016
Approval date [2] 295413 0
12/07/2013
Ethics approval number [2] 295413 0
X13-0166 & HREC/13RPAH/259

Summary
Brief summary
This study looks at whether the addition of adjuvant chemotherapy to standard cisplatin-based chemoradiation improves outcomes in women with locally advanced cervical cancer.

Who is it for?
You can join this study if you have locally advanced cervical cancer which is suitable for primary treatment with chemoradiation and you have not received any previous pelvic radiotherapy.

Trial details:
Participants will be divided into two groups. Both groups will be treated with standard external beam radiation treatment to the pelvis and brachytherapy(internal radiotherapy). They will receive cisplatin intravenously during the radiation at a dose of 40mg/m2 weekly for 5 doses. One group will also receive 4 cycles of 3 weekly adjuvant chemotherapy using carboplatin and paclitaxel intravenously, beginning within 4 weeks of completion of all radiation treatment. The study aims to see whether the adjuvant chemotherapy increases the response to treatment and improves survival times.
Trial website
http://www.anzgog.org.au
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 30795 0
A/Prof Linda Mileshkin
Address 30795 0
Peter MacCallum Cancer Centre
305 Grattan Street
Melbourne VIC 3000
Country 30795 0
Australia
Phone 30795 0
+61 3 8559 5000
Fax 30795 0
Email 30795 0
Linda.Mileshkin@petermac.org
Contact person for public queries
Name 14042 0
Mr OUTBACK Trial Coordinator
Address 14042 0
c/o OUTBACK
NHMRC Clinical Trials Centre
Locked Bag 77
Camperdown NSW 1450
Country 14042 0
Australia
Phone 14042 0
+ 61 2 9562 5000
Fax 14042 0
+ 61 2 9562 5094
Email 14042 0
outback@ctc.usyd.edu.au
Contact person for scientific queries
Name 4970 0
Mr OUTBACK Trial Coordinator
Address 4970 0
c/o OUTBACK
NHMRC Clinical Trials Centre
Locked Bag 77
Camperdown NSW 1450
Country 4970 0
Australia
Phone 4970 0
+ 61 2 9562 5000
Fax 4970 0
+ 61 2 9562 5094
Email 4970 0
outback@ctc.usyd.edu.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No/undecided IPD sharing reason/comment
What supporting documents are/will be available?
Summary results
Have study results been published in a peer-reviewed journal?
Other publications
Have study results been made publicly available in another format?
Results – basic reporting
Results – plain English summary