Condition category
Cancer
Date applied
06/04/2000
Date assigned
06/04/2000
Last edited
14/09/2007
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Professor Ann Barrett

ORCID ID

Contact details

Beatson Oncology Centre
Western Infirmary
Dumbarton Road
Glasgow
G11 6NT
United Kingdom

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 measures

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

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 20 7636 5422
clinical.trial@headoffice.mrc.ac.uk

Sponsor type

Research council

Website

http://www.mrc.ac.uk

Funders

Funder type

Research council

Funder name

Medical Research Council (UK)

Alternative name(s)

MRC

Funding Body Type

private sector organisation

Funding Body Subtype

other non-profit

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

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

  1. 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.

  2. 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.

  3. 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.

Additional files

Editorial Notes