Contact information
Type
Scientific
Primary contact
Mr Desmond Barton
ORCID ID
Contact details
Gynaecology Unit
Royal Marsden NHS Trust
Fulham Road
Chelsea
London
SW3 6JJ
United Kingdom
+44 (0)20 7352 8171
desmond.barton@rmh.nhs.uk
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N0258123595
Study information
Scientific title
Groin ultrasound and fine needle aspiration cytology in the conservative management of the groin nodes in primary squamous cell cancer of the vulva
Acronym
Study hypothesis
To compare groin and lower limb morbidity in the groin surgery group (GS) and the non-groin surgery group (NGS). Comparison of quality of life between the two groups. Events will be recorded for all patients (such as time to local or regional recurrence).
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
Condition
Cancer: Vulva
Intervention
Randomised, non-blinded (Phase 2): Groin node surgery (GS) versus no groin node surgery (NGS)
Intervention type
Other
Phase
Not Specified
Drug names
Primary outcome measures
If this study shows that in patients with squamous cell cancer of the vulva and with a negative groin USS and FNAC groin node surgery can be safely avoided then this will have a major impact in the following areas:
1. Improved quality of life with patient morbidity
2. Increased demand on the radiology services and, in pairticular, a need for a dedicated radiologist to undertake the initial USS assessment and subsequent USS surveillance. Such skills should be available in a Cancer Centre treating gynaecological cancer patients.
3. Potentially this study could lead to a fundamental change in the management of the groin nodes in vulval cancer
4. Likely reduction in hospitalisation following surgery
5. Likely reduction in the time to return to work and/or return to normal activities
Secondary outcome measures
Not provided at time of registration
Overall trial start date
01/05/2003
Overall trial end date
31/12/2006
Reason abandoned
Eligibility
Participant inclusion criteria
Not provided at time of registration
Participant type
Patient
Age group
Not Specified
Gender
Female
Target number of participants
Total number Royal Marsden Hospital (RMH) patients 40
Participant exclusion criteria
Not provided at time of registration
Recruitment start date
01/05/2003
Recruitment end date
31/12/2006
Locations
Countries of recruitment
United Kingdom
Trial participating centre
Gynaecology Unit
London
SW3 6JJ
United Kingdom
Sponsor information
Organisation
Department of Health
Sponsor details
Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom
Sponsor type
Government
Website
Funders
Funder type
Government
Funder name
The Royal Marsden NHS Trust (UK)
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