Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
CE3003
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
Cervix
Intervention
1. 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 type
Drug
Phase
Not Specified
Drug names
bleomycin, ifosfamide, cisplatin
Primary outcome measures
Not provided at time of registration
Secondary outcome measures
Not provided at time of registration
Overall trial start date
01/01/1988
Overall trial end date
31/12/1995
Reason abandoned
Eligibility
Participant inclusion criteria
1. 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
Participant type
Patient
Age group
Adult
Gender
Female
Target number of participants
172
Participant exclusion criteria
Not provided at time of registration
Recruitment start date
01/01/1988
Recruitment end date
31/12/1995
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
2000 results on http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Retrieve&db=pubmed&dopt=Abstract&list_uids=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.