Additional identifiers
EudraCT number
ClinicalTrials.gov number
NCT00003209
Protocol/serial number
CE3004
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
Condition
Cervix
Intervention
1. Arm A: Chemotherapy with single agent cisplatinum repeated every 21 days for a maximum of six courses.
2. Arm B: Multi-drug chemotherapy with bleomycin, ifosfamide and cisplatinum (BIP) repeated every 21 days for a maximum of six courses.
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
01/01/1990
Overall trial end date
28/02/1996
Reason abandoned
Eligibility
Participant inclusion criteria
1. Histologically proven recurrent invasive squamous cell carcinoma of the cervix uteri
2. Symptomatic inoperable pelvic or metastatic disease not amenable to local radiotherapy
3. No previous chemotherapy with any of the study agents
4. World Health Organisation (WHO) performance status >2
5. Adequate renal hepatic and haematological function
6. Adequate pulmonary function
7. Expected survival of >3 months
8. No second primary tumour other than basal cell carcinoma of the skin
9. No other serious medical or psychological condition precluding treatment
Participant type
Patient
Age group
Not Specified
Gender
Female
Target number of participants
Not provided at time of registration
Participant exclusion criteria
Not provided at time of registration
Recruitment start date
01/01/1990
Recruitment end date
28/02/1996
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
Funders
Funder type
Charity
Funder name
Cancer Research UK
Alternative name(s)
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
1. 2000 results in http://www.ncbi.nlm.nih.gov/pubmed/11061615
Publication citations
-
Results
Herod J, Burton A, Buxton J, Tobias J, Luesley D, Jordan S, Dunn J, Poole CJ, A randomised, prospective, phase III clinical trial of primary bleomycin, ifosfamide and cisplatin (BIP) chemotherapy followed by radiotherapy versus radiotherapy alone in inoperable cancer of the cervix., Ann. Oncol., 2000, 11, 9, 1175-1181.