A trial comparing conventional fractionation with 'CHART' in the treatment of head and neck cancer

ISRCTN ISRCTN68133429
DOI https://doi.org/10.1186/ISRCTN68133429
Secondary identifying numbers CH02
Submission date
28/02/2001
Registration date
28/02/2001
Last edited
29/10/2019
Recruitment status
No longer recruiting
Overall study status
Completed
Condition category
Cancer
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year

Plain English summary of protocol

Not provided at time of registration

Contact information

Dr James Lyddiard
Scientific

MRC Clinical Trials Unit
222 Euston Road
London
NW1 2DA
United Kingdom

Email abc@email.com

Study information

Study designRandomised controlled trial
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Not specified
Study typeNot Specified
Scientific titleA trial comparing conventional fractionation with 'CHART' in the treatment of head and neck cancer
Study objectivesTo 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(s)Not provided at time of registration
Health condition(s) or problem(s) studiedCancer
InterventionConventional 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 typeOther
Primary outcome measure1. Local tumour control
2. Survival
3. Morbidity
Secondary outcome measuresNot provided at time of registration
Overall study start date01/01/1990
Completion date01/03/1995

Eligibility

Participant type(s)Patient
Age groupNot Specified
SexNot Specified
Target number of participants500
Key inclusion criteria1. 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
Key exclusion criteriaThere should be no evidence of distant metastases beyond the regional nodes in the neck
Date of first enrolment01/01/1990
Date of final enrolment01/03/1995

Locations

Countries of recruitment

  • England
  • United Kingdom

Study participating centre

MRC Clinical Trials Unit
London
NW1 2DA
United Kingdom

Sponsor information

Medical Research Council (MRC) (UK)
Research council

20 Park Crescent
London
W1B 1AL
United Kingdom

Phone +44 (0)20 7636 5422
Email clinical.trial@headoffice.mrc.ac.uk
Website http://www.mrc.ac.uk

Funders

Funder type

Research council

Medical Research Council (MRC) (UK)
Government organisation / National government
Alternative name(s)
Medical Research Council (United Kingdom), UK Medical Research Council, MRC
Location
United Kingdom

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot provided at time of registration
IPD sharing plan

Editorial Notes

29/10/2019: No publications found. All search options exhausted.