Condition category
Cancer
Date applied
08/11/2000
Date assigned
08/11/2000
Last edited
16/07/2012
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Contact information

Type

Scientific

Primary contact

Prof Michele I Saunders

ORCID ID

Contact details

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

Additional identifiers

EudraCT number

ClinicalTrials.gov number

NCT00021125

Protocol/serial number

E164/7 (CHARTWEL/CH03)

Study information

Scientific title

Acronym

CHARTWEL

Study hypothesis

The aim of the study is to compare CHARTWEL given over 16 days with conventional radical radiotherapy given daily over 6 weeks. Preventing recurrence of the disease is the primary outcome measure. Toxicity from the treatments, both early and late, disease-free and overall survival will also be assessed.

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

Arm 1 - CHARTWEL radiotherapy. A total of 34 treatments of 1.5 Gy should be given three times per day, Monday to Friday in two consecutive weeks and the Monday and Tuesday of the following week (12 treatment days). An interval of at least 6 h must be arranged between the commencement of two treatments. A boost dose, which is recommended, of 2 x 1.5 Gy should be given on the final treatment day. A total of 51 Gy + 3 Gy boost.

Arm 2 - Conventional radiotherapy. A total of 30 treatments of 2 Gy should be given once-a-day 5 days per week, over a period of 6 weeks (30 treatment days). A boost dose, which is recommended, of 2 x 2 Gy should be given on the last two treatment days. A total of 60 Gy + 4 Gy boost.

Intervention type

Other

Phase

Not Specified

Drug names

Primary outcome measures

The primary outcome measure, which will be used to evaluate the efficacy of the treatment regimens, will be time to local recurrence.

Secondary outcome measures

1. Length of survival
2. Morbidity/toxicity (see form CH03/7)
3. Quality of life (EORTC QLQ H&N 35 Pro forma, CH03/QoL)

Overall trial start date

01/04/2000

Overall trial end date

31/03/2005

Reason abandoned

Eligibility

Participant inclusion criteria

1. Surgically resected and histologically proven squamous cell carcinoma of the head and neck area at high or intermediate risk of recurrence within the head and neck region
2. Elective surgery performed with the intention to cure
3. The patient must be treatable by a radiotherapy technique which can be used in both arms of the trial
4. The patient should have no other concurrent or previous malignant disease likely to interfere with protocol treatment or comparisons
5. Adequate follow-up possible
6. Written informed consent

Participant type

Patient

Age group

Not Specified

Gender

Not Specified

Target number of participants

460

Participant exclusion criteria

1. Distant metastases beyond regional nodes in the neck.
2. Time from surgery to commencement of radiotherapy greater than 70 days.
3. Unable to tolerate protocol treatments

Recruitment start date

01/04/2000

Recruitment end date

31/03/2005

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 (0)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

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

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes