A randomised controlled trial of radical radiotherapy alone versus radical surgery plus radical radiotherapy for patients with cancer of the oral cavity

ISRCTN	ISRCTN89427989
DOI	https://doi.org/10.1186/ISRCTN89427989
Secondary identifying numbers	HN10

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Record updated in last year

Plain English summary of protocol

Not provided at time of registration

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Scientific

UKCCCR Register Co-ordinator
MRC Clinical Trials Unit
222 Euston Road
London
NW1 2DA
United Kingdom

Study design	Randomised controlled trial
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Hospital
Study type	Treatment
Participant information sheet	Not available in web format, please use the contact details below to request a patient information sheet
Scientific title	A randomised controlled trial of radical radiotherapy alone versus radical surgery plus radical radiotherapy for patients with cancer of the oral cavity
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. 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.
Intervention type	Mixed
Primary outcome measure	Not provided at time of registration
Secondary outcome measures	Not provided at time of registration
Overall study start date	01/01/1995
Completion date	31/12/2005

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Sex	Both
Target number of participants	Not provided at time of registration
Key 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
Key exclusion criteria	Not provided at time of registration
Date of first enrolment	01/01/1995
Date of final enrolment	31/12/2005

MRC Clinical Trials Unit

London
NW1 2DA
United Kingdom

UK Co-ordinating Committee for Cancer Research (UKCCCR)
Government

MRC Clinical Trials Unit
222 Euston Road
London
NW1 2DA
United Kingdom

"ROR"	https://ror.org/054225q67

Research organisation

Cancer organisations

No information available

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