Plain English Summary
Trial website
Contact information
Type
Scientific
Primary contact
Prof Jeffrey Tobias
ORCID ID
Contact details
University College Hospital
235 Euston Road
London
NW1 2BU
United Kingdom
+44 (0)20 7380 9214
j.tobias@uclh.org
Additional identifiers
EudraCT number
ClinicalTrials.gov number
NCT00002476
Protocol/serial number
UKCCCRUKHAN1
Study information
Scientific title
Acronym
Study hypothesis
Not provided at time of registration
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
Treatment
Patient information sheet
Condition
Head and neck cancer
Intervention
1. Group A: Radiotherapy alone.
2. Group B: Radiotherapy plus simultaneous chemotherapy (two courses during radiotherapy).
3.Group C: Radiotherapy plus subsequent chemotherapy (two courses to start 14 days and 28 days following radiotherapy).
4. Group D: Radiotherapy plus simultaneous and subsequent chemotherapy. (A total of four courses of chemotherapy, two simultaneous with radiotherapy treatment and two 14 days and 28 days following the completion of radiotherapy.)
Radiotherapy is given according to standard local practices. Suggested radiotherapy regimens include 60 Gy in 6 weeks or 45-55 Gy in 3-4 weeks. Recommended chemotherapy regimens are single agent methotrexate or combination chemotherapy with vincristine, bleomycin, methotrexate and 5-fluorouracil (VBMF). Patients in whom the primary tumour has been surgically excised are randomised to group A or group B only.
Intervention type
Other
Phase
Not Applicable
Drug names
Primary outcome measure
Not provided at time of registration
Secondary outcome measures
Not provided at time of registration
Overall trial start date
15/01/1990
Overall trial end date
20/06/2000
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
1. Histological confirmation of squamous cell carcinoma
2. All stages, except T1N0
3. No occult primaries
4. No evidence of distant metastases
5. Fit and willing to receive any of the randomised treatment options
Participant type
Patient
Age group
Not Specified
Gender
Both
Target number of participants
Not provided at time of registration
Participant exclusion criteria
Not provided at time of registration
Recruitment start date
15/01/1990
Recruitment end date
20/06/2000
Locations
Countries of recruitment
United Kingdom
Trial participating centre
University College Hospital
London
NW1 2BU
United Kingdom
Sponsor information
Organisation
Cancer Research UK (CRUK) (UK)
Sponsor details
PO Box 123
Lincoln's Inn Fields
London
WC2A 3PX
United Kingdom
+44 (0)207 317 5186
kate.law@cancer.org.uk
Sponsor type
Charity
Website
Funders
Funder type
Charity
Funder name
Cancer Research UK
Alternative name(s)
CRUK
Funding Body Type
private sector organisation
Funding Body Subtype
Other non-profit organizations
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
Basic results (scientific)
Publication list
2010 results in http://www.ncbi.nlm.nih.gov/pubmed/19875337
Publication citations
-
Results
Tobias JS, Monson K, Gupta N, Macdougall H, Glaholm J, Hutchison I, Kadalayil L, Hackshaw A, , Chemoradiotherapy for locally advanced head and neck cancer: 10-year follow-up of the UK Head and Neck (UKHAN1) trial., Lancet Oncol., 2010, 11, 1, 66-74, doi: 10.1016/S1470-2045(09)70306-7.