Condition category
Date applied
Date assigned
Last edited
Retrospectively registered
Overall trial status
Recruitment status
No longer recruiting
Publication status

Contact information



Primary contact

Dr Paul Vasey


Contact details

Cancer Research UK Trials Unit
E Block
Beatson Oncology Centre
Western Infirmary
G11 6NT
United Kingdom
+44 (0)141 211 2318/2009

Additional identifiers

EudraCT number number


Protocol/serial number


Study information

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 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


Secondary study design

Randomised controlled trial

Trial setting


Trial type


Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet


Advanced ovarian cancer


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



Not Specified

Drug names

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 trial start date


Overall trial end date


Reason abandoned (if study stopped)


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


Age group




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


Recruitment end date



Countries of recruitment

United Kingdom

Trial participating centre

Cancer Research UK Trials Unit
G11 6NT
United Kingdom

Sponsor information


University of Glasgow (UK)

Sponsor details

Cancer Research UK Clinical Trials Unit
E Block
Beatson Oncology Centre
Western Infirmary
G11 6NT
United Kingdom
+44 (0)141 211 6287

Sponsor type




Funder type


Funder name

Cancer Research UK (CRUK) (UK)

Alternative name(s)


Funding Body Type

private sector organisation

Funding Body Subtype

Other non-profit organizations


United Kingdom

Funder name

Scottish Gynaecological Cancer Trials Group (SGCTG) (UK)

Alternative name(s)

Funding Body Type

Funding Body Subtype


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

Basic results (scientific)

Publication list

2013 results in:

Publication citations

  1. 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.

Additional files

Editorial Notes

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