After mapping of the axilla: radiotherapy or surgery

• Register: ISRCTN
• Last refreshed on: 7 October 2019
• Main ID: ISRCTN13672866
• Date of registration: 29/04/2010
• Prospective Registration: No
• Primary sponsor: European Organisation for Research and Treatment of Cancer (EORTC) (Belgium)
• Public title: After mapping of the axilla: radiotherapy or surgery
• Scientific title: A phase III study comparing a complete axillary lymph node dissection with radiotherapy to the axilla in sentinel biopsy positive patients
• Date of first enrolment: 08/03/2007
• Target sample size: 600
• Recruitment status: Completed
• URL: http://isrctn.com/ISRCTN13672866
• Study type: Interventional
• Study design: Randomised interventional treatment trial (Treatment)
• Phase: Phase III

Countries of recruitment

United Kingdom

Contacts

• Name: Christine Morris

Key inclusion & exclusion criteria

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

Exclusion criteria: Does not meet inclusion criteria

Age minimum:
Age maximum:
Gender: Female

Health Condition(s) or Problem(s) studied

Topic: National Cancer Research Network; Subtopic: Breast Cancer; Disease: Breast
Cancer
Breast cancer

Intervention(s)

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

Primary Outcome(s)

Axillary recurrence rate after 5 years.

Secondary Outcome(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.

Secondary ID(s)

NCT00014612

1424; EORTC 10981-22023

Source(s) of Monetary Support

European Organisation for Research and Treatment of Cancer (EORTC) (Belgium)

Ethics review

Status:
Approval date:
Contact:

Multi-Centre Research Ethics Committee for Wales approved on the 22nd October 2005 (ref: 05/MRE09/61)

Results

• Results available: Yes
• Date Completed: 01/05/2010