Condition category
Cancer
Date applied
19/08/2002
Date assigned
19/08/2002
Last edited
08/11/2012
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

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 measures

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

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

http://www.cancer.org.uk

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

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

Results - basic reporting

Publication summary

2010 results in http://www.ncbi.nlm.nih.gov/pubmed/19875337

Publication citations

  1. 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.

Additional files

Editorial Notes