Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12607000188437
Ethics application status
Approved
Date submitted
27/03/2007
Date registered
30/03/2007
Date last updated
22/08/2011
Type of registration
Retrospectively registered

Titles & IDs
Public title
A randomised, two-arm, multi-centre Gynaecologic Cancer InterGroup trial of adding bevacizumab to standard chemotherapy (carboplatin and paclitaxel) in patients with epithelial ovarian cancer
Scientific title
A randomised, two-arm, multi-centre Gynaecologic Cancer InterGroup trial of adding bevacizumab to standard chemotherapy (carboplatin and paclitaxel) in patients with epithelial ovarian cancer to assess progression-free survival benefits
Secondary ID [1] 353 0
International Standard Randomized Controlled Trial Number (ISRCTN): ISRCYN91273375
Universal Trial Number (UTN)
Trial acronym
ICON 7
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Epithelial ovarian cancer, fallopian tube cancer and primary peritoneal cancer 1706 0
Condition category
Condition code
Cancer 1798 1798 0 0
Ovarian and primary peritoneal

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Research Arm: Carboplatin (Intravenously, AUC 6) plus paclitaxel (Intravenously, 175mg/m2) on day 1 every 3 weeks (one cycle) until disease progression or for a maximum of 6 cycles, with bevacizumab (intravenously, 7.5mg/kg) on day 1 every 3 weeks (one cycle) until disease progression or for a maximum of 18 cycles
Intervention code [1] 1670 0
Treatment: Drugs
Comparator / control treatment
Control Arm: Carboplatin (Intravenously, AUC 6) plus paclitaxel (Intravenously, 175mg/m2) on day 1 every 3 weeks (one cycle) until disease progression or for a maximum of 6 cycles
Control group
Active

Outcomes
Primary outcome [1] 2519 0
Progression-free survival (PFS)
Timepoint [1] 2519 0
At baseline, after Cycle 3, 6, 9 and 12, and every 6 months thereafter until disease progression.
Secondary outcome [1] 4342 0
1. Overall Survival (OS).
Timepoint [1] 4342 0
Timepoints: (before disease progression) 3 monthly during years 2 and 3, 6 monthly during years 4 and 5, then yearly; (after disease progression) 6 monthly during first 5 years, then yearly.
Secondary outcome [2] 4343 0
2. Response Rate and Duration of Response.
Timepoint [2] 4343 0
At baseline, after Cycle 3, 6, 9 and 12, and every 6 months thereafter until disease progression.
Secondary outcome [3] 4344 0
3. Toxicity.
Timepoint [3] 4344 0
Before each cycle, at safety follow-up visit (between week 56-58 since start of treatment, or between 4-6 weeks after last bevacizumab treatment, whichever occurs later; or between 4-6 weeks after date of progression if progression occurs less than 56 weeks from start of treatment), and toxicities related to study treatment continuing after the safety follow-up visit should be followed-up until resolved or relationship to treatment changed.
Secondary outcome [4] 4345 0
4. Quality of life (QoL).
Timepoint [4] 4345 0
Before cycles 1, 2, 3, 4, 5, 6, 8, 10, 12, 14, 16, 18; then 15, 18, 21, 24 and 36 months after randomisation.
Secondary outcome [5] 4346 0
5. Health Economics.
Timepoint [5] 4346 0
Before each cycle, then 3 monthly during years 2 and 3, 6 monthly during years 4 and 5, then yearly.
Secondary outcome [6] 4347 0
6. Translational (biomarker) Research.
Timepoint [6] 4347 0
Timepoints (depending on level of participation from each patient): at baseline, before cycles 1, 2 and 6, and at time of disease progression, after cycles 1 and 6, and at follow-up 3, 6 and 12 months after end of treatment.

Eligibility
Key inclusion criteria
1. Written informed consent and able to comply with the protocol2. Histologically confirmed:a. High risk International Federation of Gynecology and Obstetrics (FIGO) stage I and II a, with grade 3 or clear cell histology, epithelial ovarian cancerb. FIGO stage IIb–IV (all grades, all histological types) epithelial ovarian cancerc. Fallopian tube or primary peritoneal cancer3. Patients fit enough to receive protocol treatment4. Urine dipstick for proteinuria <2+ (if urine dipstick is > or = 2+, 24 hour urine must demonstrate < or = 1 g of protein).
Minimum age
18 Years
Maximum age
No limit
Sex
Females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Surgery (including open biopsy), or radiotherapy within the last 4 weeks prior to first dose of bevacizumab or anticipation of interval cytoreductive surgery during study treatment2. Malignancies other than ovarian cancer within 5 years prior to randomisation, except for adequately treated carcinoma in situ of the cervix and/or basal cell skin cancer3. Uncontrolled hypertension4. Current or recent (within 10 days of first dose of study treatment) use of aspirin >325 mg/day5. Current or recent (within 10 days prior to study treatment start) use of full-dose oral or parenteral anticoagulants or thrombolytic agent for therapeutic purposes (except for line patency).

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)
Central randomisation by computer (web-based)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
1:1 ratio using stratified block randomisation stratifying for the following factors:FIGO stage, intent to start chemotherapy = or > 4 weeks following surgery, and Gynaecologic Cancer Intergroup (GCIG) group.
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
18/12/2006
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
1520
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 1951 0
Government body
Name [1] 1951 0
Medical Research Council (UK)
Country [1] 1951 0
United Kingdom
Primary sponsor type
Government body
Name
Medical Research Council (UK)
Address
Medical Research Council
14th Floor
One Kemble Street
London
WC2B 4AN
Country
United Kingdom
Secondary sponsor category [1] 1763 0
Commercial sector/Industry
Name [1] 1763 0
F. Hoffmann-La Roche
Address [1] 1763 0
C/- Medical Research Council
14th Floor
One Kemble Street
London
WC2B 4AN
Country [1] 1763 0
Switzerland

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 3628 0
Auckland Hospital
Ethics committee address [1] 3628 0
Ethics committee country [1] 3628 0
New Zealand
Date submitted for ethics approval [1] 3628 0
Approval date [1] 3628 0
Ethics approval number [1] 3628 0
Ethics committee name [2] 3629 0
Border Medical Oncology
Ethics committee address [2] 3629 0
Ethics committee country [2] 3629 0
Australia
Date submitted for ethics approval [2] 3629 0
10/09/2007
Approval date [2] 3629 0
07/03/2008
Ethics approval number [2] 3629 0
HREC Ref. 07/RPAH/83
Ethics committee name [3] 3630 0
Box Hill Hospital
Ethics committee address [3] 3630 0
Ethics committee country [3] 3630 0
Australia
Date submitted for ethics approval [3] 3630 0
Approval date [3] 3630 0
Ethics approval number [3] 3630 0
Ethics committee name [4] 3631 0
Christchurch Hospital
Ethics committee address [4] 3631 0
Ethics committee country [4] 3631 0
New Zealand
Date submitted for ethics approval [4] 3631 0
Approval date [4] 3631 0
Ethics approval number [4] 3631 0
Ethics committee name [5] 3632 0
Dunedin Hospital
Ethics committee address [5] 3632 0
Ethics committee country [5] 3632 0
New Zealand
Date submitted for ethics approval [5] 3632 0
Approval date [5] 3632 0
Ethics approval number [5] 3632 0
Ethics committee name [6] 3633 0
Liverpool Hospital
Ethics committee address [6] 3633 0
Ethics committee country [6] 3633 0
Australia
Date submitted for ethics approval [6] 3633 0
Approval date [6] 3633 0
Ethics approval number [6] 3633 0
Ethics committee name [7] 3634 0
Mater Adult Brisbane
Ethics committee address [7] 3634 0
Ethics committee country [7] 3634 0
Australia
Date submitted for ethics approval [7] 3634 0
Approval date [7] 3634 0
Ethics approval number [7] 3634 0
Ethics committee name [8] 3635 0
Mercy Hospital For Women
Ethics committee address [8] 3635 0
Ethics committee country [8] 3635 0
Australia
Date submitted for ethics approval [8] 3635 0
Approval date [8] 3635 0
Ethics approval number [8] 3635 0
Ethics committee name [9] 3636 0
Newcastle Mater Misericordiae Hospital
Ethics committee address [9] 3636 0
Ethics committee country [9] 3636 0
Australia
Date submitted for ethics approval [9] 3636 0
Approval date [9] 3636 0
Ethics approval number [9] 3636 0
Ethics committee name [10] 3637 0
Prince of Wales Hospital
Ethics committee address [10] 3637 0
Ethics committee country [10] 3637 0
Australia
Date submitted for ethics approval [10] 3637 0
Approval date [10] 3637 0
Ethics approval number [10] 3637 0
Ethics committee name [11] 3638 0
Royal Adelaide Hospital
Ethics committee address [11] 3638 0
Ethics committee country [11] 3638 0
Australia
Date submitted for ethics approval [11] 3638 0
Approval date [11] 3638 0
Ethics approval number [11] 3638 0
Ethics committee name [12] 3639 0
Royal Brisbane and Women's Hospital
Ethics committee address [12] 3639 0
Ethics committee country [12] 3639 0
Australia
Date submitted for ethics approval [12] 3639 0
Approval date [12] 3639 0
Ethics approval number [12] 3639 0
Ethics committee name [13] 3640 0
Royal Hobart Hospital
Ethics committee address [13] 3640 0
Ethics committee country [13] 3640 0
Australia
Date submitted for ethics approval [13] 3640 0
Approval date [13] 3640 0
Ethics approval number [13] 3640 0
Ethics committee name [14] 3641 0
Royal North Shore Hospital
Ethics committee address [14] 3641 0
Ethics committee country [14] 3641 0
Australia
Date submitted for ethics approval [14] 3641 0
Approval date [14] 3641 0
Ethics approval number [14] 3641 0
Ethics committee name [15] 3642 0
Royal Prince Alfred Hospital
Ethics committee address [15] 3642 0
Ethics committee country [15] 3642 0
Australia
Date submitted for ethics approval [15] 3642 0
Approval date [15] 3642 0
Ethics approval number [15] 3642 0
Ethics committee name [16] 3643 0
Royal Women's Hospital
Ethics committee address [16] 3643 0
Ethics committee country [16] 3643 0
Australia
Date submitted for ethics approval [16] 3643 0
Approval date [16] 3643 0
Ethics approval number [16] 3643 0
Ethics committee name [17] 3644 0
Sir Charles Gairdner Hospital
Ethics committee address [17] 3644 0
Ethics committee country [17] 3644 0
Australia
Date submitted for ethics approval [17] 3644 0
Approval date [17] 3644 0
Ethics approval number [17] 3644 0
Ethics committee name [18] 3645 0
Wellington Hospital
Ethics committee address [18] 3645 0
Ethics committee country [18] 3645 0
New Zealand
Date submitted for ethics approval [18] 3645 0
Approval date [18] 3645 0
Ethics approval number [18] 3645 0
Ethics committee name [19] 3646 0
Westmead Hospital
Ethics committee address [19] 3646 0
Ethics committee country [19] 3646 0
Australia
Date submitted for ethics approval [19] 3646 0
Approval date [19] 3646 0
Ethics approval number [19] 3646 0

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 27773 0
Address 27773 0
Country 27773 0
Phone 27773 0
Fax 27773 0
Email 27773 0
Contact person for public queries
Name 10859 0
Dr Julie Martyn
Address 10859 0
ANZGOG Coordinating Centre
NHMRC Clinical Trials Centre
Locked Bag 77
Camperdown NSW 1450
Country 10859 0
Australia
Phone 10859 0
+61 2 95625092
Fax 10859 0
+61 2 95625094
Email 10859 0
[email protected]
Contact person for scientific queries
Name 1787 0
Dr Philip Beale
Address 1787 0
Sydney Cancer Centre
Royal Prince Alfred Hospital
Missenden Rd
Camperdown NSW 2050
Country 1787 0
Australia
Phone 1787 0
+61 2 95155895
Fax 1787 0
+61 2 95191546
Email 1787 0
[email protected]

No information has been provided regarding IPD availability


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.