UKHAN1 - A Trial of Chemotherapy With Radiotherapy in the Treatment of Advanced Squamous Carcinoma of the Head and Neck

ISRCTN	ISRCTN93127929
DOI	https://doi.org/10.1186/ISRCTN93127929
ClinicalTrials.gov number	NCT00002476
Secondary identifying numbers	UKCCCRUKHAN1

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Prof Jeffrey Tobias
Scientific

University College Hospital
235 Euston Road
London
NW1 2BU
United Kingdom

Phone	+44 (0)20 7380 9214
Email	j.tobias@uclh.org

Study design	Randomised controlled trial
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Not specified
Study type	Treatment
Scientific title
Study objectives	Not provided at time of registration
Ethics approval(s)	Not provided at time of registration
Health condition(s) or problem(s) studied	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
Primary outcome measure	Not provided at time of registration
Secondary outcome measures	Not provided at time of registration
Overall study start date	15/01/1990
Completion date	20/06/2000

Participant type(s)	Patient
Age group	Not Specified
Sex	Both
Target number of participants	Not provided at time of registration
Key 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
Key exclusion criteria	Not provided at time of registration
Date of first enrolment	15/01/1990
Date of final enrolment	20/06/2000

University College Hospital

London
NW1 2BU
United Kingdom

Cancer Research UK (CRUK) (UK)
Charity

PO Box 123
Lincoln's Inn Fields
London
WC2A 3PX
United Kingdom

Charity

Cancer Research UK
Private sector organisation / Other non-profit organizations

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

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results	01/01/2010		Yes	No