After mapping of the axilla: radiotherapy or surgery

ISRCTN	ISRCTN13672866
DOI	https://doi.org/10.1186/ISRCTN13672866
ClinicalTrials.gov (NCT)	NCT00014612
Protocol serial number	1424; EORTC 10981-22023
Sponsor	European Organisation for Research and Treatment of Cancer (EORTC) (Belgium)
Funder	European Organisation for Research and Treatment of Cancer (EORTC) (Belgium)

Submission date: 29/04/2010
Registration date: 29/04/2010
Last edited: 10/09/2019

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Cancer

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

http://cancerhelp.cancerresearchuk.org/trials/a-trial-comparing-radiotherapy-and-surgery-for-women-with-breast-cancer-which-has-spread-to-their-lymph-nodes

Contact information

Mrs Christine Morris
Scientific

Cardiff & Vale Breast Centre
University Hospital Llandough
Llandough
Cardiff
CF64 2XX
United Kingdom

Study information

Primary study design	Interventional
Study design	Randomised interventional treatment trial
Secondary study design	Randomised controlled trial
Study type	Participant information sheet
Scientific title	A phase III study comparing a complete axillary lymph node dissection with radiotherapy to the axilla in sentinel biopsy positive patients
Study acronym	EORTC 10981 (AMAROS)
Study objectives	After mapping of the axillary: radiotherapy or surgery, is a phase III study comparing a complete axillary lymph node dissection with radiotherapy to the axilla in sentinel biopsy positive patients, where-as sentinel node negative patients are followed for the end-points of the study as well.
Ethics approval(s)	Multi-Centre Research Ethics Committee for Wales approved on the 22nd October 2005 (ref: 05/MRE09/61)
Health condition(s) or problem(s) studied	Topic: National Cancer Research Network; Subtopic: Breast Cancer; Disease: Breast
Intervention	Patients will be stratified by institution and will be randomised between complete axillary lymph node dissection and radiotherapy of the axilla. Follow up length: 5 years Study entry: single randomisation only
Intervention type	Other
Primary outcome measure(s)	Axillary recurrence rate after 5 years.
Key secondary outcome measure(s)	1. Shoulder function analysis 2. Quality of life 3. Arm circumference Node positive patients have annual examination and mammograms for 10 years. Quality of life questionnaire, arm circumference and shoulder function measurements measured at 1, 2, 3, 5 and 10 years.
Completion date	01/05/2010

Eligibility

Participant type(s)	Patient
Age group	Other
Sex	Female
Target sample size at registration	600
Key inclusion criteria	1. Invasive breast cancer proven by core biopsy or 'triple diagnosis': clinical palpation concordant with malignancy, imaging (mammography or ultrasound) and tumour positive FNA cytology; diagnosis by excisional tumourectomy is allowed. Clinically occult invasive cancer should be proven by histology. 2. Tumour larger than 5 and smaller than 30 mm in its largest diameter, measured by mammography or ultrasound, only one tumour site (palpation, mammogram or ultrasound) in one breast: bilateral unifocal invasive breast cancer is allowed, (bilateral mammogram is mandatory) 3. Clinically negative axillary lymph nodes 4. Patient has to be fit to undergo any of the following treatments: SN-biopsy, axillary clearance, breast surgery, radiation therapy of the axilla 5. Before patient registration/randomisation, informed consent must be obtained according to ICH/EU GCP, and national/local regulations 6. Female, all ages considered 7. Absence of any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule; those conditions should be discussed with the patient before registration in the trial 8. No metastatic disease (routine investigations are not required: symptoms should be investigated on indication) 9. No previous treatment of the axilla by surgery or radiotherapy 10. No previous treatment of cancer, except Basal Cell Carcinoma of the skin and in situ carcinoma of the cervix 11. No pregnancy
Key exclusion criteria	Does not meet inclusion criteria
Date of first enrolment	08/03/2007
Date of final enrolment	01/05/2010

Locations

Countries of recruitment

United Kingdom
Wales

Study participating centre

Cancer Trials Unit

Cardiff
CF14 4XN
United Kingdom

Results and Publications

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results	01/11/2014		Yes	No
Results article	results	01/06/2013	10/09/2019	Yes	No
Results article	results (Dutch)	01/11/2015	10/09/2019	Yes	No
Participant information sheet	Participant information sheet	11/11/2025	11/11/2025	No	Yes
Plain English results				No	Yes

Editorial Notes

10/09/2019: The following changes were made to the trial record:
1. ClinicalTrials.gov number added.
2. Publication references added.
19/10/2018: Cancer Research UK lay results summary link added to Results (plain English)
27/11/2015: Publication reference added.