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 (NCT) | NCT00098878 |
| Protocol serial number | SCOTROC 4 |
| Sponsor | University of Glasgow (UK) |
| Funders | Cancer Research UK (CRUK) (UK), Scottish Gynaecological Cancer Trials Group (SGCTG) (UK) |
- 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
Contact information
Dr Paul Vasey
Scientific
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 |
|---|---|
| p.vasey@beatson.gla.ac.uk |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Multicentre randomised active controlled parallel group trial |
| Secondary study design | Randomised controlled trial |
| Study type | Participant 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(s) |
Added 11/08/09: |
| Key secondary outcome measure(s) |
Added 11/08/09: |
| Completion date | 31/05/2005 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Female |
| Target sample size at registration | 1300 |
| 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
- United Kingdom
- Scotland
Study participating centre
Cancer Research UK Trials Unit
Glasgow
G11 6NT
United Kingdom
G11 6NT
United Kingdom
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 01/03/2013 | Yes | No | |
| Participant information sheet | Participant information sheet | 11/11/2025 | 11/11/2025 | No | Yes |
| Plain English results | No | Yes |
Editorial Notes
19/10/2018: Cancer Research UK lay results summary link added to Results (plain English)
