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

ISRCTN	ISRCTN47645935
DOI	https://doi.org/10.1186/ISRCTN47645935
ClinicalTrials.gov number	NCT00098878
Secondary identifying numbers	SCOTROC 4

Submission date: 29/03/2004
Registration date: 21/04/2004
Last edited: 19/10/2018

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Cancer

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

http://cancerhelp.cancerresearchuk.org/trials/a-trial-comparing-the-same-dose-with-an-increasing-dose-of-carboplatin-for-ovarian-cancer

Contact information

Dr Paul Vasey
Scientific

Cancer Research UK Trials Unit
E Block
Beatson Oncology Centre
Western Infirmary
Glasgow
G11 6NT
United Kingdom

Phone	+44 (0)141 211 2318/2009
Email	p.vasey@beatson.gla.ac.uk

Study information

Study design	Multicentre randomised active controlled parallel group trial
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Hospital
Study type	Treatment
Participant information sheet	Not available in web format, please use the contact details below to request a patient information sheet
Scientific title	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
Study acronym	SCOTROC 4
Study objectives	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(s)	Added 11/08/09: Ethics approval from West Hertfordshire Research Ethics Committee on 06/10/2003 (ref: MREC/3/3/40)
Health condition(s) or problem(s) studied	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
Primary outcome measure	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 study start date	01/04/2000
Completion date	31/05/2005

Eligibility

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Sex	Female
Target number of participants	1300 (Added 11/08/09)
Key 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
Key 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
Date of first enrolment	01/04/2000
Date of final enrolment	31/05/2005

Locations

Countries of recruitment

Scotland
United Kingdom

Study participating centre

Cancer Research UK Trials Unit

Glasgow
G11 6NT
United Kingdom

Sponsor information

University of Glasgow (UK)
University/education

Cancer Research UK Clinical Trials Unit
E Block
Beatson Oncology Centre
Western Infirmary
Glasgow
G11 6NT
Scotland
United Kingdom

Phone	+44 (0)141 211 6287
Email	j.paul@clinmed.gla.ac.uk
"ROR"	https://ror.org/00vtgdb53

Funders

Funder type

Charity

Cancer Research UK (CRUK) (UK)
Private sector organisation / Other non-profit organizations

Alternative name(s): CR_UK, Cancer Research UK - London, CRUK
Location: United Kingdom

Scottish Gynaecological Cancer Trials Group (SGCTG) (UK)

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
Publication and dissemination plan	Not provided at time of registration
IPD sharing plan

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Plain English results				No	Yes
Results article	results	01/03/2013		Yes	No

Editorial Notes

19/10/2018: Cancer Research UK lay results summary link added to Results (plain English)