Condition category
Cancer
Date applied
29/03/2004
Date assigned
21/04/2004
Last edited
02/09/2013
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

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)

CRUK

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

  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