Plain English Summary
Trial website
Additional identifiers
EudraCT number
ClinicalTrials.gov number
NCT00021125
Protocol/serial number
E164/7 (CHARTWEL/CH03)
Study information
Scientific title
Acronym
CHARTWEL
Study hypothesis
The aim of the study is to compare CHARTWEL given over 16 days with conventional radical radiotherapy given daily over 6 weeks. Preventing recurrence of the disease is the primary outcome measure. Toxicity from the treatments, both early and late, disease-free and overall survival will also be assessed.
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
Arm 1 - CHARTWEL radiotherapy. A total of 34 treatments of 1.5 Gy should be given three times per day, Monday to Friday in two consecutive weeks and the Monday and Tuesday of the following week (12 treatment days). An interval of at least 6 h must be arranged between the commencement of two treatments. A boost dose, which is recommended, of 2 x 1.5 Gy should be given on the final treatment day. A total of 51 Gy + 3 Gy boost.
Arm 2 - Conventional radiotherapy. A total of 30 treatments of 2 Gy should be given once-a-day 5 days per week, over a period of 6 weeks (30 treatment days). A boost dose, which is recommended, of 2 x 2 Gy should be given on the last two treatment days. A total of 60 Gy + 4 Gy boost.
Intervention type
Other
Phase
Not Specified
Drug names
Primary outcome measures
The primary outcome measure, which will be used to evaluate the efficacy of the treatment regimens, will be time to local recurrence.
Secondary outcome measures
1. Length of survival
2. Morbidity/toxicity (see form CH03/7)
3. Quality of life (EORTC QLQ H&N 35 Pro forma, CH03/QoL)
Overall trial start date
01/04/2000
Overall trial end date
31/03/2005
Reason abandoned
Eligibility
Participant inclusion criteria
1. Surgically resected and histologically proven squamous cell carcinoma of the head and neck area at high or intermediate risk of recurrence within the head and neck region
2. Elective surgery performed with the intention to cure
3. The patient must be treatable by a radiotherapy technique which can be used in both arms of the trial
4. The patient should have no other concurrent or previous malignant disease likely to interfere with protocol treatment or comparisons
5. Adequate follow-up possible
6. Written informed consent
Participant type
Patient
Age group
Not Specified
Gender
Not Specified
Target number of participants
460
Participant exclusion criteria
1. Distant metastases beyond regional nodes in the neck.
2. Time from surgery to commencement of radiotherapy greater than 70 days.
3. Unable to tolerate protocol treatments
Recruitment start date
01/04/2000
Recruitment end date
31/03/2005
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