Condition category
Cancer
Date applied
01/07/2001
Date assigned
01/07/2001
Last edited
27/02/2015
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

- - -

ORCID ID

Contact details

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

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

HN10

Study information

Scientific title

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

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

Hospitals

Trial type

Treatment

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

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

Phase

Drug names

Primary outcome measures

Not provided at time of registration

Secondary outcome measures

Not provided at time of registration

Overall trial start date

01/01/1995

Overall trial end date

31/12/2005

Reason abandoned

Eligibility

Participant 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

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

Not provided at time of registration

Participant exclusion criteria

Not provided at time of registration

Recruitment start date

01/01/1995

Recruitment end date

31/12/2005

Locations

Countries of recruitment

United Kingdom

Trial participating centre

MRC Clinical Trials Unit
London
NW1 2DA
United Kingdom

Sponsor information

Organisation

UK Co-ordinating Committee for Cancer Research (UKCCCR)

Sponsor details

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

Sponsor type

Government

Website

Funders

Funder type

Research organisation

Funder name

Cancer organisations

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

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

Publication citations

Additional files

Editorial Notes