Condition category
Cancer
Date applied
01/07/2001
Date assigned
01/07/2001
Last edited
02/02/2012
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr - -

ORCID ID

Contact details

UKCCCR Register Co-ordinator
MRC Clinical Trials Unit
222 Euston Road
London
NW1 2DA
United Kingdom

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

G31

Study information

Scientific title

Acronym

Study hypothesis

Not provided at time of registration

Ethics approval

Not provided at time of registration

Study design

Randomised controlled 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

Ovarian Cancer

Intervention

1. Group A: Cisplatin 50 mg/m2 plus 750 mg/m2 cyclophosphamide repeated every 3 weeks for a maximum of six cycles
2. Group B: Cisplatin 100 mg/m2 plus 750 mg/m2 cyclophosphamide repeated every 3 weeks for a maximum of six cycles

Intervention type

Other

Phase

Not Specified

Drug names

Primary outcome measures

Not provided at time of registration

Secondary outcome measures

Not provided at time of registration

Overall trial start date

01/01/1991

Overall trial end date

01/03/1991

Reason abandoned

Eligibility

Participant inclusion criteria

1. Confirmed diagnosis of invasive epithelial ovarian carcinoma including the following histological subtypes: Serous cystadenocarcinoma; Mucinous cystadenocarcinoma; Endometriod carcinoma; Clear cell (mesonephroid) carcinoma; Undifferentiated carcinoma
2. International Federation of Gynecology and Obstetrics (FIGO) stage Ic, II, III and IV
3. Age 18 -70 years
4. Eastern Cooperative Oncology Group (ECOG) performance status 0-2
5. Life expectancy of at least 3 months
6. Adequate bone marrow and renal function
7. No previous chemotherapy or radiotherapy
8. No history of previous malignancy, except adequately treated basal cell carcinoma of the skin or in situ carcinoma of the cervix
9. No serious intercurrent disease

Participant type

Patient

Age group

Adult

Gender

Female

Target number of participants

Not provided at time of registration

Participant exclusion criteria

Does not match inclusion criteria

Recruitment start date

01/01/1991

Recruitment end date

01/03/1991

Locations

Countries of recruitment

United Kingdom

Trial participating centre

UKCCCR Register Co-ordinator
London
NW1 2DA
United Kingdom

Sponsor information

Organisation

Cancer Research UK (CRUK) (UK)

Sponsor details

PO Box 123
Lincoln's Inn Fields
London
WC2A 3PX
United Kingdom
+44 (0)207 317 5186
kate.law@cancer.org.uk

Sponsor type

Charity

Website

http://www.cancer.org.uk

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

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

1992 results in http://www.ncbi.nlm.nih.gov/pubmed/1353804

Publication citations

  1. Results

    Kaye SB, Lewis CR, Paul J, Duncan ID, Gordon HK, Kitchener HC, Cruickshank DJ, Atkinson RJ, Soukop M, Rankin EM, Randomised study of two doses of cisplatin with cyclophosphamide in epithelial ovarian cancer., Lancet, 1992, 340, 8815, 329-333.

Additional files

Editorial Notes