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ISRCTN
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ISRCTN77727725
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DOI
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10.1186/ISRCTN77727725
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ClinicalTrials.gov identifier
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EudraCT number
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Public title
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Completion of documentation of late effects of treatment of patients in both arms of the CHART studies (for previous work, refer to MRC Headoffice)
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Scientific title
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Acronym
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N/A
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Serial number at source
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G9615854/9005262
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Study hypothesis
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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).
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Lay summary
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Ethics approval
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Not provided at time of registration
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Study design
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Randomised controlled trial
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Countries of recruitment
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United Kingdom
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Disease/condition/study domain
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Cancer
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Participants - inclusion criteria
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Locally advanced cancer of the bronchus and in the major head and neck sites
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Participants - exclusion criteria
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Not provided at time of registration
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Anticipated start date
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01/07/1998
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Anticipated end date
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01/07/2000
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Status of trial
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Completed |
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Patient information material
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Target number of participants
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49 patients (bronchus) + 379 (head & neck)
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Interventions
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CHART/conventional radiotherapy
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Primary outcome measure(s)
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The documentation of late effects as specified in the original CHART studies
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Secondary outcome measure(s)
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Not provided at time of registration
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Sources of funding
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Medical Research Council (UK)
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Trial website
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Publications
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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).
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Contact name
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Professor
Ann
Barrett
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Address
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Beatson Oncology Centre
Western Infirmary
Dumbarton Road
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City/town
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Glasgow
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Zip/Postcode
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G11 6NT
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Country
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United Kingdom
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Email
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Sponsor
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Medical Research Council (MRC) (UK)
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Address
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20 Park Crescent
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City/town
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London
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Zip/Postcode
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W1B 1AL
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Country
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United Kingdom
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Tel
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+44 (0)20 7636 5422
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Fax
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+44 (0)20 7436 6179
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Email
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clinical.trial@headoffice.mrc.ac.uk
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Sponsor website:
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http://www.mrc.ac.uk
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Date applied
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06/04/2000
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Last edited
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14/09/2007
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Date ISRCTN assigned
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06/04/2000
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