CHARTWEL - Continuous Hyperfractionated Accelerated Radiotherapy Week-End Less

ISRCTN	ISRCTN62576956
DOI	https://doi.org/10.1186/ISRCTN62576956
ClinicalTrials.gov number	NCT00021125
Secondary identifying numbers	E164/7 (CHARTWEL/CH03)

Submission date: 08/11/2000
Registration date: 08/11/2000
Last edited: 28/01/2019

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

http://cancerhelp.cancerresearchuk.org/trials/radiotherapy-3-times-a-day-vs-radiotherapy-daily-for-head-and-neck-cancer

Contact information

Prof Michele I Saunders
Scientific

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

Email	abc@email.com

Study information

Study design	Randomised controlled trial
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Not specified
Study type	Not Specified
Scientific title	CHARTWEL - Continuous Hyperfractionated Accelerated Radiotherapy Week-End Less
Study acronym	CHARTWEL
Study objectives	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(s)	Not provided at time of registration
Health condition(s) or problem(s) studied	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
Primary outcome measure	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 study start date	01/04/2000
Completion date	31/03/2005

Eligibility

Participant type(s)	Patient
Age group	Not Specified
Sex	Not Specified
Target number of participants	460
Key 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
Key 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
Date of first enrolment	01/04/2000
Date of final enrolment	31/03/2005

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 share	No
IPD sharing plan summary	Not provided at time of registration
Publication and dissemination plan	Not provided at time of registration
IPD sharing plan

Editorial Notes

28/01/2019: No publications found. Verifying status with the principal investigator