Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
CH01
Study information
Scientific title
Acronym
Study hypothesis
To compare the effectiveness of radical fractionated radiotherapy given daily over six weeks with CHART over 12 days, with respect to survival, local tumour control and morbidity
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
Not specified
Trial type
Not Specified
Patient information sheet
Condition
Cancer
Intervention
1. Conventional radiotherapy arm - 2 Gy, once daily five days a week over six weeks (large volume - 44 Gy in 22 fractions followed by small volume - 16 Gy in eight fractions)
2. CHART arm - 1.5 Gy, three time daily over 12 treatment days (large volume - 37.5 Gy in 25 fractions followed by small volume - 16.5 Gy in 11 fractions)
Intervention type
Other
Phase
Not Specified
Drug names
Primary outcome measure
Survival, Local tumour control, Morbidity
Secondary outcome measures
Not provided at time of registration
Overall trial start date
01/02/1990
Overall trial end date
01/03/1995
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
Inoperable non-small cell carcinoma of the bronchus confined to the thorax proven by histology or by unequivocal brush cytology
Participant type
Patient
Age group
Not Specified
Gender
Both
Target number of participants
600
Participant exclusion criteria
1. There should be no evidence of distant metastases including supraclavicular nodes;
2. The patient must have no evidence of a pleural effusion unless it can be attributed to a recent surgical intervention;
3. The volume of the site of tumour within the thorax should be such that a radical course of radiotherapy could be given without prejudicing vital structures such as the spinal cord or lung
Recruitment start date
01/02/1990
Recruitment end date
01/03/1995
Locations
Countries of recruitment
United Kingdom
Trial participating centre
MRC Clinical Trials Unit
London
NW1 2DA
United Kingdom
Sponsor information
Organisation
Medical Research Council (MRC) (UK)
Sponsor details
20 Park Crescent
London
W1B 1AL
United Kingdom
+44 (0)20 7636 5422
clinical.trial@headoffice.mrc.ac.uk
Sponsor type
Research council
Website
Funders
Funder type
Research council
Funder name
Medical Research Council (MRC) (UK)
Alternative name(s)
MRC
Funding Body Type
government organisation
Funding Body Subtype
Federal/National Government
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
Basic results (scientific)
Publication list