Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
CH02
Study information
Scientific title
Acronym
Study hypothesis
To compare the effectiveness of radical fractionated radiotherapy given daily over 6 weeks with CHART over 12 days, with respect to local tumour control, survival 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
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)
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 measures
1. Local tumour control
2. Survival
3. Morbidity
Secondary outcome measures
Not provided at time of registration
Overall trial start date
01/01/1990
Overall trial end date
01/03/1995
Reason abandoned
Eligibility
Participant inclusion criteria
1. Histologically proven squamous cell carcinoma of all grades at one of the following sites: Nasal sinuses, Nasopharynx, Oral cavity, Oropharynx, Hypopharynx, Carcinoma of the larynx
2. A radical course of external beam radiotherapy is the appropriate sole treatment
Participant type
Patient
Age group
Not Specified
Gender
Not Specified
Target number of participants
500
Participant exclusion criteria
There should be no evidence of distant metastases beyond the regional nodes in the neck
Recruitment start date
01/01/1990
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
Results - basic reporting
Publication summary