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

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

Primary study design	Interventional
Study design	Randomised controlled trial
Secondary study design	Randomised controlled trial
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(s)	Not provided at time of registration
Key secondary outcome measure(s)	Not provided at time of registration
Completion date	20/06/2000

Participant type(s)	Patient
Age group	Not Specified
Sex	All
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

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary
IPD sharing plan

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