| Source of record | UK Trials |
| ISRCTN | ISRCTN89427989 |
| Date ISRCTN assigned | 01/07/2001 |
| Local reference number(s) | HN10 |
| Public title | A randomised controlled trial of radical radiotherapy alone versus radical surgery plus radical radiotherapy for patients with cancer of the oral cavity |
| 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. Histologically proven squamous cell carcinoma of all grades at one of the following sites (except any patient with disease stage T1 N0): Tongue; Floor of mouth/alveolus; Retromolar trigone; Tonsil/lateral pharyngeal wall
2. Aged >18 years
3. No evidence of distant metastases beyond the regional neck nodes in the neck
4. No other malignancy, except basal cell carcinomas of the skin or intraepithelial carcinoma of the cervix
5. WHO performance status 0-2
6. Fit for radical surgery |
| 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 | Patients are randomised to one of two treatment arms:
1. Arm A: Radical radiotherapy to the primary tumour and to the anterior triangles of the neck.
2. Arm B: Radical surgery involving wide local excision of the intra oral tumour with approximately a 1 cm margin and immediate reconstruction of the oral cavity. Neck dissection should be performed either for access to the oral cavity or for clearance of suspected clinically positive nodes. Following surgery patients receive radical radiotherapy to the primary tumour and to the anterior triangles of the neck. |
| Primary outcome measure(s) | Not provided at time of registration |
| Secondary outcome measure(s) | Not provided at time of registration |
| Sources of funding | Not available |
| Sponsor name | UK Co-ordinating Committee for Cancer Research (UKCCCR) |
| Sponsor details | MRC Clinical Trials Unit
222 Euston Road
London
United Kingdom
NW1 2DA |
| Sponsor telephone | +44 (0) 20 7670 4723 |
| Sponsor fax | +44 (0) 20 7670 4818 |
| Sponsor email | register@ctu.mrc.ac.uk |
| Sponsor website | http://www.ctu.mrc.ac.uk/ukcccr/home.html |
| 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 | ISRCTN89427989 |
| Date last extracted from ISRCTN register | 17/04/2008 |
