A multicentre, randomised trial of primary chemotherapy in inoperable cervical cancer

ISRCTN ISRCTN26689999
DOI https://doi.org/10.1186/ISRCTN26689999
Secondary identifying numbers CE3003
Submission date
01/07/2001
Registration date
01/07/2001
Last edited
01/02/2012
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

Not provided at time of registration

Contact information

Dr - -
Scientific

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

Study information

Study designRandomised controlled trial
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Hospital
Study typeTreatment
Participant information sheet Not available in web format, please use the contact details below to request a patient information sheet
Scientific title
Study objectivesNot provided at time of registration
Ethics approval(s)Not provided at time of registration
Health condition(s) or problem(s) studiedCervix
Intervention1. Arm A: Radical pelvic radiotherapy
2. Arm B: Primary chemotherapy with bleomycin, ifosfamide and cisplatinum repeated every 28 days for two courses followed by radical pelvic radiotherapy. If after two courses of chemotherapy the measurable disease has not been reduced to <2 cm diameter and if further response is expected, then a third course of chemotherapy may be given followed by radical pelvic radiotherapy.
Intervention typeDrug
Pharmaceutical study type(s)
PhaseNot Specified
Drug / device / biological / vaccine name(s)bleomycin, ifosfamide, cisplatin
Primary outcome measureNot provided at time of registration
Secondary outcome measuresNot provided at time of registration
Overall study start date01/01/1988
Completion date31/12/1995

Eligibility

Participant type(s)Patient
Age groupAdult
SexFemale
Target number of participants172
Key inclusion criteria1. Histologically proven invasive squamous cell carcinoma of the cervix uteri
2. Inoperable disease, that is stage II, III or IVA. Stage IIA disease may be included if deemed inoperable by the referring gynaecologist
3. No previous treatment for invasive cervical cancer
4. World Health Organisation (WHO) performance status >2
5. Adequate renal hepatic and haematological function
6. Adequate pulmonary function
7. Patients with a probability of <0.2 of not developing severe encephalopathy with ifosfamide/mensa treatment are excluded
8. Expected survival of >3 months
9. No second primary tumour other than basal cell carcinoma of the skin
10. No other serious medical or psychological condition precluding treatment
Key exclusion criteriaNot provided at time of registration
Date of first enrolment01/01/1988
Date of final enrolment31/12/1995

Locations

Countries of recruitment

  • England
  • United Kingdom

Study participating centre

UKCCCR Register Co-ordinator
London
NW1 2DA
United Kingdom

Sponsor information

Cancer Research UK (CRUK) (UK)
Charity

PO Box 123
Lincoln's Inn Fields
London
WC2A 3PX
United Kingdom

Phone +44 (0)207 317 5186
Email kate.law@cancer.org.uk
Website http://www.cancer.org.uk
ROR logo "ROR" https://ror.org/054225q67

Funders

Funder type

Charity

Cancer Research UK
Private sector organisation / Other non-profit organizations
Alternative name(s)
CR_UK, Cancer Research UK - London, CRUK
Location
United Kingdom

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot provided at time of registration
IPD sharing plan

Study outputs

Output type Details Date created Date added Peer reviewed? Patient-facing?
Results article results 01/09/2000 Yes No