| Source of record | UK Clinical Trials Gateway |
| ISRCTN | ISRCTN93127929 |
| Date ISRCTN assigned | 19/08/2002 |
| Local reference number(s) | UKCCCRUKHAN1 |
| Public title | UKHAN1 - A Trial of Chemotherapy With Radiotherapy in the Treatment of Advanced Squamous Carcinoma of the Head and Neck |
| Scientific title |
|
| Acronym | Not Applicable |
| Disease/condition/study domain | Head and Neck |
| Study hypothesis | Not provided at time of registration |
| Design/methodology | Randomised controlled trial |
| Research ethics review | Not provided at time of registration |
| Countries of trial | United Kingdom |
| Participants - 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 |
| Participants - exclusion criteria | Not provided at time of registration |
| Patient information material |
|
| Status of trial | Completed |
| Target number of participants | Not provided at time of registration |
| Interventions | 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. |
| Primary outcome measure(s) | Not provided at time of registration |
| Secondary outcome measure(s) | Not provided at time of registration |
| Sources of funding | Cancer Research UK |
| Sponsor name | Cancer Research UK |
| Sponsor details | PO Box 123
Lincoln's Inn Fields
London
United Kingdom
WC2A 3PX |
| Sponsor telephone | +44 (0)20 7317 5186 |
| Sponsor fax | +44 (0)20 7487 4302 |
| Sponsor email | kate.law@cancer.org.uk |
| Sponsor website | http://www.cancer.org.uk |
| Contact name | Dr - - |
| Contact details | UKCCCR Register Co-ordinator
MRC Clinical Trials Unit
222 Euston Road
London
United Kingdom
NW1 2DA |
| Contact telephone | +44 (0) 20 7670 4723 |
| Contact fax | +44 (0) 20 7670 4818 |
| Contact email | register@ctu.mrc.ac.uk |
| More information | For more up-to-date information please go to the ISRCTN link below. |
| Link to record in ISRCTN Register | ISRCTN93127929 |
| Date last extracted from ISRCTN register | 17/04/2008 |
