Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
RMH E/C 1475
Study information
Scientific title
A randomised trial comparing 8 cycles of CPT11 with CPT11 until disease progression in patients with colorectal cancer resistant to 5-fluorouracil
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
Colorectal cancer
Intervention
1. CPT11 350 mg/m2 IV over 30 min every 3 weeks
2. No treatment
Intervention type
Other
Phase
Not Specified
Drug names
Primary outcome measure
Not provided at time of registration
Secondary outcome measures
Not provided at time of registration
Overall trial start date
16/10/1997
Overall trial end date
31/12/2005
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
1. Histological evidence of metastatic adenocarcinoma of colon or rectum not amenable to surgery or radiotherapy
2. Documented evidence of disease progression by Computed Tomography (CT) within 24 weeks of last 5FU
Participant type
Patient
Age group
Not Specified
Gender
Not Specified
Target number of participants
Not provided at time of registration
Participant exclusion criteria
Not provided at time of registration
Recruitment start date
16/10/1997
Recruitment end date
31/12/2005
Locations
Countries of recruitment
United Kingdom
Trial participating centre
MRC Clinical Trials Unit
London
NW1 2DA
United Kingdom
Funders
Funder type
Hospital/treatment centre
Funder name
Royal Marsden Hospital (UK)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
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
Basic results (scientific)
Publication list