Condition category
Cancer
Date applied
28/02/2001
Date assigned
28/02/2001
Last edited
05/11/2012
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

Dr James Lyddiard

ORCID ID

Contact details

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

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

CH02

Study information

Scientific title

Acronym

Study hypothesis

To 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

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

Conventional 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 type

Other

Phase

Not Specified

Drug names

Primary outcome measures

1. Local tumour control
2. Survival
3. Morbidity

Secondary outcome measures

Not provided at time of registration

Overall trial start date

01/01/1990

Overall trial end date

01/03/1995

Reason abandoned

Eligibility

Participant inclusion criteria

1. 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

Participant type

Patient

Age group

Not Specified

Gender

Not Specified

Target number of participants

500

Participant exclusion criteria

There should be no evidence of distant metastases beyond the regional nodes in the neck

Recruitment start date

01/01/1990

Recruitment end date

01/03/1995

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 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 (MRC) (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

Publication citations

Additional files

Editorial Notes