Axillary surgery trial for breast cancer
| ISRCTN | ISRCTN88463711 | 
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN88463711 | 
| Secondary identifying numbers | SCTO30 | 
- Submission date
 - 19/08/2002
 - Registration date
 - 19/08/2002
 - Last edited
 - 07/04/2015
 
- Recruitment status
 - No longer recruiting
 - Overall study status
 - Completed
 - Condition category
 - Cancer
 
            
            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
Contact information
                                            - -
Scientific
                                        Scientific
                                                UKCCCR Register Co-ordinator
MRC Clinical Trials Unit
222 Euston Road
London
NW1 2DA
United Kingdom
                                                
Study information
| Study design | Randomised controlled trial | 
|---|---|
| Primary study design | Interventional | 
| Secondary study design | Randomised controlled trial | 
| Study setting(s) | Hospital | 
| Study type | Treatment | 
| Scientific title | Axillary surgery trial for breast cancer | 
| Study objectives | Not provided at time of registration | 
| Ethics approval(s) | Not provided at time of registration | 
| Health condition(s) or problem(s) studied | Breast cancer | 
| Intervention | 1. Group A: Surgery, wide local excision and axillary node sampling, followed by radiotherapy to the breast and if the sample is positive, radiotherapy to the axillary lymph nodes  2. Group B: Surgery, wide local excision and axillary node clearance plus radiotherapy to the breast  | 
| Intervention type | Procedure/Surgery | 
| Primary outcome measure | Not provided at time of registration | 
| Secondary outcome measures | Not provided at time of registration | 
| Overall study start date | 01/01/2003 | 
| Completion date | 01/01/2004 | 
Eligibility
| Participant type(s) | Patient | 
|---|---|
| Age group | Adult | 
| Sex | Female | 
| Target number of participants | Not provided at time of registration | 
| Key inclusion criteria | 1. Histologically proven breast cancer  2. Tumour size no greater than 4 cm 3. No skin involvement 4. Aged less than 70 years 5. No medical contraindications to treatment protocols  | 
| Key exclusion criteria | Not provided at time of registration | 
| Date of first enrolment | 01/01/2003 | 
| Date of final enrolment | 01/01/2004 | 
Locations
Countries of recruitment
- England
 - United Kingdom
 
Study participating centre
                                            MRC Clinical Trials Unit
                                        
                                        
                                            
                                            London
NW1 2DA
United Kingdom
                                    NW1 2DA
United Kingdom
Sponsor information
                                            UK Co-ordinating Committee for Cancer Research (UKCCCR)
Government
                                        Government
                                                MRC Clinical Trials Unit
222 Euston Road
London
NW1 2DA
United Kingdom
                                                
| https://ror.org/054225q67 | 
Funders
Funder type
Not defined
                                                Not provided at time of registration
                                            
                                            No information available
Results and Publications
| 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 |