Plain English Summary
Trial website
Contact information
Type
Scientific
Primary contact
Dr Paul Vasey
ORCID ID
Contact details
Cancer Research UK Trials Unit
E Block
Beatson Oncology Centre
Western Infirmary
Glasgow
G11 6NT
United Kingdom
+44 (0)141 211 2318/2009
p.vasey@beatson.gla.ac.uk
Additional identifiers
EudraCT number
ClinicalTrials.gov number
NCT00098878
Protocol/serial number
SCOTROC 4
Study information
Scientific title
Acronym
SCOTROC 4
Study hypothesis
Added 11/08/09:
The aim of this study is to determine whether intrapatient dose escalation of carboplatin gives superior progression-free survival to flat dosing of carboplatin in untreated ovarian cancer patients.
Please note that as of 11/08/09 this record has been extensively updated. All updates will appear in the relevant field with the above update date. Please also note that the sponsor information has been updated, initially the sponsor was listed as undefined.
Secondary sponsor:
NHS Greater Glasgow and Clyde (NHSGGC) Board
Dalian House
PO Box 15329
350 St. Vincent Street
Glasgow G3 8YZ
Ethics approval
Added 11/08/09: Ethics approval from West Hertfordshire Research Ethics Committee on 06/10/2003 (ref: MREC/3/3/40)
Study design
Multicentre randomised active controlled parallel group trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Not available in web format, please use the contact details below to request a patient information sheet
Condition
Advanced ovarian cancer
Intervention
Patients will be randomised to receive EITHER Carboplatin flat dose (no dose escalation) OR Carboplatin with an intra-patient dose escalation scheme based on nadir blood counts. The dose of Carboplatin in both arms for cycle 1 will be based on the glomerular filtration rate calculated by the Cockcroft-Gault formula, and dosed to an AUC of 6 by the Calvert formula.
Intervention type
Other
Phase
Not Specified
Drug names
Primary outcome measures
Added 11/08/09:
Progression-free survival
Secondary outcome measures
Added 11/08/09:
1. Toxicity
2. Quality of life
3. Response rates (clinical and CA125)
4. Overall survival
Overall trial start date
01/04/2000
Overall trial end date
31/05/2005
Reason abandoned
Eligibility
Participant inclusion criteria
Current information as of 11/08/09:
1. Patients with histologically confirmed epithelial ovarian carcinoma, or primary fallopian tube carcinoma, considered unsuitable or unwilling for treatment with platinum-taxane combination therapy. Patients with peritoneal carcinomatosis (ovarian-type) are also eligible, without necessarily having histological proof of a primary source in the ovary, provided that the tumour is not mucin-secreting (see exclusion criteria).
2. Female, aged 18 or over.
3. 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.
4. Written informed consent
5. Can comply with follow up requirements
6. Intention to treat patient within 8 weeks of initial surgery.
Initial information at time of registration:
Patients with histologically confirmed epithelial ovarian carcinoma (stage IC - IV), or primary fallopian tube carcinoma, considered unsuitable or unwilling for treatment with platinum-taxane combination therapy
Participant type
Patient
Age group
Adult
Gender
Female
Target number of participants
1300 (Added 11/08/09)
Participant exclusion criteria
Added 11/08/09:
1. ECOG performance > 3
2. Prior treatment with chemotherapy and radiotherapy
3. Inadequate bone marrow function defined as neutrophils < 1.5 or plateles < 100
4. Inadequate renal function as defined by calculated creatinine clearance (Cockcroft-Gault) of < 30ml/min. Obstructive hydronephrosis as a cause of "borderline" (eg 30-45 ml/min) renal function should be investigated and treated prior to study entry.
5. Inadequate liver function as defined by bilirubin > upper limit of normal or AST/ALT >2.5 x upper limit of normal or ALP > 5 x upper limit of normal.
6. Concurrent severe and/or uncontrolled co-morbid medical condition (i.e. uncontrolled infection, hypertension, ischaemic heart disease, myocardial infarction within previous 6 months, congestive heart failure)
7. Patient with mixed mesodermal tumours
8. Patients with boderline ovarian tumours or tumours termed "possibly malignant"
9. Adenocarcinoma of unknown origin, if histologically shown
Recruitment start date
01/04/2000
Recruitment end date
31/05/2005
Locations
Countries of recruitment
United Kingdom
Trial participating centre
Cancer Research UK Trials Unit
Glasgow
G11 6NT
United Kingdom
Sponsor information
Organisation
University of Glasgow (UK)
Sponsor details
Cancer Research UK Clinical Trials Unit
E Block
Beatson Oncology Centre
Western Infirmary
Glasgow
G11 6NT
United Kingdom
+44 (0)141 211 6287
j.paul@clinmed.gla.ac.uk
Sponsor type
University/education
Website
Funders
Funder type
Charity
Funder name
Cancer Research UK (CRUK) (UK)
Alternative name(s)
Funding Body Type
private sector organisation
Funding Body Subtype
other non-profit
Location
United Kingdom
Funder name
Scottish Gynaecological Cancer Trials Group (SGCTG) (UK)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Results - basic reporting
Publication summary
2013 results in: http://www.ncbi.nlm.nih.gov/pubmed/23041585
Publication citations
-
Results
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, doi: 10.1093/annonc/mds494.