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Trial registered on ANZCTR


Registration number
ACTRN12605000694617
Ethics application status
Approved
Date submitted
18/10/2005
Date registered
28/10/2005
Date last updated
5/03/2014
Type of registration
Prospectively registered

Titles & IDs
Public title
SCOTROC 4
Scientific title
SCOTROC 4: A Prospective, Multicentre, Randomised Trial of Carboplatin Flat Dosing Vs Intrapatient Dose Escalation in First Line Chemotherapy of Ovarian, Fallopian Tube and Primary Peritoneal Cancers, to improve progression-free survival.
Secondary ID [1] 205 0
National Clinical Trials Registry: NCTR449
Universal Trial Number (UTN)
Trial acronym
SCOTROC 4
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Ovarian, Fallopian Tube and Primary Peritoneal Cancers 843 0
Condition category
Condition code
Cancer 910 910 0 0
Ovarian and primary peritoneal

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Chemotherapy: Carboplatin given over 6 cycles, 3 weekly.
Intervention code [1] 723 0
Treatment: Drugs
Comparator / control treatment
Flat dose (Arm A) or Intra-patient dose escalation (Arm B). The mode of administration is intravenous infusion. Each treatment cycle involves a single dose performed at the start of 3 week periods for a total of 6 cycles. The dose of Carboplatin in both arms for cycle 1 will be dosed to Area Ander Curve (AUC) of 6. Dose escalation in Arm B will be based on the nadir count from the previous cycle. Doses will increase by either 10 or 20% depending on the blood counts.
Control group
Dose comparison

Outcomes
Primary outcome [1] 1184 0
Progression-free survival
Timepoint [1] 1184 0
Measured at the time of suspected or clinical progression.
Secondary outcome [1] 2166 0
Toxicities
Timepoint [1] 2166 0
Measured each cycle
Secondary outcome [2] 2167 0
Quality of life
Timepoint [2] 2167 0
Measured each cycle and 2 months post treatment
Secondary outcome [3] 2168 0
Clinical overall response rates and CA125 responses
Timepoint [3] 2168 0
Measured each cycle and as routine assessments during follow-up
Secondary outcome [4] 2169 0
Overall survival
Timepoint [4] 2169 0
Measured at time of death

Eligibility
Key inclusion criteria
Histologically confirmed epithelial ovarian carcinoma, or primary fallopian tube carcinoma or peritoneal carcinomatosis (ovarian-type), considered unsuitable or unwilling for treatment with platinum-taxane combination therapy; FIGO stages Ic-IV with or without successful cytoreductive surgery at staging laparotomy (Stage Ic patients will be limited to those with malignant cells in ascitic fluid/peritoneal washings, tumour on the surface of the ovary, or pre-operative capsule rupture); Intention to treat patient within 8 weeks of initial surgery.
Minimum age
18 Years
Maximum age
Not stated
Gender
Females
Can healthy volunteers participate?
No
Key exclusion criteria
ECOG performance status > 3; Prior treatment with chemotherapy or radiotherapy; Inadequate bone marrow function, renal function or liver function; Concurrent severe and/or uncontrolled co-morbid medical condition; Patients with mixed mesodermal tumours, borderline ovarian tumours or tumours termed "possibly malignant"; Adenocarcinoma of unknown origin, if histologically shown to be mucin-secreting cancer; History of previous malignancy within the previous 5 years or concurrent malignancy (e.g. co-existing endometrial cancer); Pregnant or lactating women; Symptomatic peripheral neuropathy > NCI-CTC grade II.

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)
Centralised web-based randomisation, concealed until interventions are assigned
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Minimisation technique and Oracle JInitiator software
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
Completed
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
Recruitment outside Australia
Country [1] 243 0
New Zealand
State/province [1] 243 0

Funding & Sponsors
Funding source category [1] 1004 0
Other Collaborative groups
Name [1] 1004 0
SGCTG
Address [1] 1004 0
CRUK Clinical Trials Unit
Glasgow
Country [1] 1004 0
United Kingdom
Funding source category [2] 1005 0
Charities/Societies/Foundations
Name [2] 1005 0
Cancer Council Australia
Address [2] 1005 0
Sydney
Country [2] 1005 0
Australia
Primary sponsor type
Charities/Societies/Foundations
Name
SGCTG (and also investigator initiated)
Address
Cancer Research United Kingdom
Clinical Trials Unit
Beatson West of Scotland Cancer Centre
1053 Great Western Rd
Glasgow G120YN
United Kingdom
Country
United Kingdom
Secondary sponsor category [1] 864 0
Other Collaborative groups
Name [1] 864 0
ANZGOG
Address [1] 864 0
NHMRC Clinical Trials Centre
Country [1] 864 0
Australia
Secondary sponsor category [2] 865 0
University
Name [2] 865 0
University of Sydney
Address [2] 865 0
Camperdown
Country [2] 865 0
Australia
Secondary sponsor category [3] 866 0
Other Collaborative groups
Name [3] 866 0
SGCTG
Address [3] 866 0
CRUK Clinical Trials Unit
Country [3] 866 0
United Kingdom

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 2316 0
University of Sydney
Ethics committee address [1] 2316 0
Ethics committee country [1] 2316 0
Australia
Date submitted for ethics approval [1] 2316 0
Approval date [1] 2316 0
Ethics approval number [1] 2316 0
Ethics committee name [2] 2317 0
Central Ethics Committee
Ethics committee address [2] 2317 0
Ethics committee country [2] 2317 0
Australia
Date submitted for ethics approval [2] 2317 0
Approval date [2] 2317 0
Ethics approval number [2] 2317 0

Summary
Brief summary
To assess in a formal protocol whether or not an intrapatient dose-escalation strategy for carboplatin can produce an improved outcome over flat dosing.
Trial website
Trial related presentations / publications
Abstract presentation at ASCO 2009.

Final Publication - Banerjee S, Rustin G, Paul J, Williams C, Pledge S, Gabra H, Skailes G,Lamont A,Hindley A,Goss G, Gilby E, Hogg M, Harper P, Kipps E, Lewsley LA, Hall M, Vasey P, Kaye SB. A multicenter, randomized trial of flat dosing versus intrapatient dose escalation of single-agent carboplatin as first-line chemotherapy for advanced ovarian cancer: an SGCTG (SCOTROC 4) and ANZGOG study on behalf of GCIG. Ann Oncol (2013) 24 (3): 679-687
Public notes

Contacts
Principal investigator
Name 35887 0
Dr Geraldine Goss
Address 35887 0
ANZGOG Coordinating Centre NHMRC Clinical Trials Centre Locked bag 77 Camperdown NSW 1450
Country 35887 0
Australia
Phone 35887 0
+61 2 9562 5000
Fax 35887 0
Email 35887 0
scotroc4@ctc.usyd.edu.au
Contact person for public queries
Name 9912 0
Dr Dr Geraldine Goss
Address 9912 0
Locked Bag 77
Camperdown NSW 1450
Country 9912 0
Australia
Phone 9912 0
+61 2 9562 5000
Fax 9912 0
Email 9912 0
scotroc4@ctc.usyd.edu.au
Contact person for scientific queries
Name 840 0
Mrs Lisa Bailey
Address 840 0
Locked Bag 77
Camperdown NSW 1450
Country 840 0
Australia
Phone 840 0
+61 2 9562 5000
Fax 840 0
Email 840 0
scotroc4@ctc.usyd.edu.au

No information has been provided regarding IPD availability
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