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ISRCTN
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ISRCTN62576956
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DOI
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10.1186/ISRCTN62576956
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ClinicalTrials.gov identifier
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NCT00021125
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EudraCT number
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Public title
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CHARTWEL - Continuous Hyperfractionated Accelerated Radiotherapy Week-End Less
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Scientific title
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Acronym
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CHARTWEL
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Serial number at source
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E164/7 (CHARTWEL/CH03)
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Study hypothesis
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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.
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Lay summary
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http://cancerhelp.cancerresearchuk.org/trials/radiotherapy-3-times-a-day-vs-radiotherapy-daily-for-head-and-neck-cancer
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Ethics approval
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Not provided at time of registration
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Study design
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Randomised controlled trial
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Countries of recruitment
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United Kingdom
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Disease/condition/study domain
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Cancer
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Participants - inclusion criteria
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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
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Participants - exclusion criteria
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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
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Anticipated start date
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01/04/2000
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Anticipated end date
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31/03/2005
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Status of trial
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Completed |
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Patient information material
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Target number of participants
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460
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Interventions
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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.
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Primary outcome measure(s)
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The primary outcome measure, which will be used to evaluate the efficacy of the treatment regimens, will be time to local recurrence.
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Secondary outcome measure(s)
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1. Length of survival
2. Morbidity/toxicity (see form CH03/7)
3. Quality of life (EORTC QLQ H&N 35 Pro forma, CH03/QoL)
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Sources of funding
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Medical Research Council (MRC) (UK)
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Trial website
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Publications
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Contact name
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Prof
Michele I
Saunders
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Address
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MRC Clinical Trials Unit
222 Euston Road
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City/town
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London
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Zip/Postcode
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NW1 2DA
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Country
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United Kingdom
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Email
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Sponsor
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Medical Research Council (MRC) (UK)
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Address
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20 Park Crescent
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City/town
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London
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Zip/Postcode
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W1B 1AL
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Country
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United Kingdom
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Tel
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+44 (0)20 7636 5422
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Fax
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+44 (0)20 7436 6179
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Email
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clinical.trial@headoffice.mrc.ac.uk
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Sponsor website:
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http://www.mrc.ac.uk
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Date applied
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08/11/2000
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Last edited
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16/07/2012
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Date ISRCTN assigned
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08/11/2000
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