Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
G9615854/9005262
Study information
Scientific title
Acronym
Study hypothesis
The CHART trials, the largest of their kind in Europe, have shown an improvement in survival of 10% at 2 years in patients with carcinoma of the bronchus treated with CHART, as compared with conventional radiotherapy. In the head and neck trial, the overall benefit in local tumour control does not reach statistical significance but this is reached in important sub-groups. There is however as reduction in morbidity in this trial giving a therapeutic benefit. To determine the true usefulness of a new radiotherapy schedule and to build on the improvements obtained the effect on therapeutic ratio must be defined over time. During the trial full data has now been gathered and analysed concerned with acute reactions and in the follow up late morbidity and from this data we have been able to make important contributions to radiobiological knowledge in humans particularly by a calculation of the repair half-times of normal tissue being about twice as long as previously known. Recent publications include:
1. Bentzen SM, Saunders MI and Dische S. Repair half-times estimated from observations of treatment-related morbidity after CHART or conventional radiotherapy in head and neck cancer. Radiother Oncol 1999; 53:219-226
2. Ataman OU, Bentzen SM, Saunders MI and Dische S. Failure specific prognostic factors after Continuous Hyperfractionated Accelerated Radiotherapy (CHART) or conventional radiotherapy in locally advanced non-small cell lung cancer: A competing risk analysis. Br J Cancer 2001; 85:1113-1118.
3. Bentzen SM, Saunders MI, Dische S and Bond S. Radiotherapy early morbidity in head and neck cancer:quantitative clinical radiobiology as deduced from the CHART trial. Radiother Oncol 2000; 60: 123-135
4. Wilson GD, Saunders MI, Dische S, Richman PI, Daly FM and Bentzen SM. BCL-2 expression in head and neck cancer: an enigmatic prognostic marker. Int J Radiation Oncol Biology Phys 2001; 49; 435-441.
5. Bentzen SM, Saunders MI and Dische S. From CHART to CHARTWELL in non-small cell lung cancer: clinical radiobiological modelling of the expected changes in outcome. Clin Onc (Royal College of Radiologists-in press)
6. Khalil AA, bentzen SM, Bernier J, Saunders MI, Horiot J-C, van den Bogaert W, Cummings PG and Dische S. Compliance to prescribed dose and overall treatment time in five randomised clinical trials of altered radiotherapy fractionation in head and neck cancer. Int J Radiation Oncol Biol Phys (submitted 2002).
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
CHART/conventional radiotherapy
Intervention type
Other
Phase
Not Specified
Drug names
Primary outcome measure
The documentation of late effects as specified in the original CHART studies
Secondary outcome measures
Not provided at time of registration
Overall trial start date
01/07/1998
Overall trial end date
01/07/2000
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
Locally advanced cancer of the bronchus and in the major head and neck sites
Participant type
Patient
Age group
Not Specified
Gender
Not Specified
Target number of participants
49 patients (bronchus) + 379 (head & neck)
Participant exclusion criteria
Not provided at time of registration
Recruitment start date
01/07/1998
Recruitment end date
01/07/2000
Locations
Countries of recruitment
United Kingdom
Trial participating centre
Beatson Oncology Centre
Glasgow
G11 6NT
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 (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
Results:
1. http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?db=pubmed&cmd=Retrieve&dopt=Abstract&list_uids=10660202 (01/12/1999).
2. http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?db=pubmed&cmd=Retrieve&dopt=Abstract&list_uids=11439207 (01/08/2001).
3. http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?db=pubmed&cmd=Retrieve&dopt=Abstract&list_uids=11710822 (19/10/2001).
Publication citations
-
Bentzen SM, Saunders MI, Dische S, Repair halftimes estimated from observations of treatment-related morbidity after CHART or conventional radiotherapy in head and neck cancer., Radiother Oncol, 1999, 53, 3, 219-226.
-
Bentzen SM, Saunders MI, Dische S, Bond SJ, Radiotherapy-related early morbidity in head and neck cancer: quantitative clinical radiobiology as deduced from the CHART trial., Radiother Oncol, 2001, 60, 2, 123-135.
-
Ataman OU, Bentzen SM, Saunders MI, Dische S, Failure-specific prognostic factors after continuous hyperfractionated accelerated radiotherapy (CHART) or conventional radiotherapy in locally advanced non-small-cell lung cancer: a competing risks analysis., Br. J. Cancer, 2001, 85, 8, 1113-1118, doi: 10.1054/bjoc.2001.2049.