|- candidate number||8596|
|- NTR Number||NTR2579|
|- ISRCTN||ISRCTN wordt niet meer aangevraagd.|
|- Date ISRCTN created|
|- date ISRCTN requested|
|- Date Registered NTR||28-okt-2010|
|- Secondary IDs||NL31664.029.10 METc VU University Medical Center|
|- Public Title||Ultrasound-guided breast-conserving surgery.|
|- Scientific Title||Ultrasound-guided breast-sparing surgery to improve cosmetic outcomes and quality of life.|
A prospective multicentre randomised controlled clinical trial comparing ultrasound-guided surgery to traditional palpation-guided surgery.
|- ACRONYM||COBALT trial|
|- hypothesis||It is hypothesised that the use of intra-operative ultrasonography in the excision of palpable breast cancer compared with the standard palpation-guided surgery will improve the ability to spare healthy breast tissue while maintaining or even improving the oncological margin status. |
|- Healt Condition(s) or Problem(s) studied||Breast cancer, Quality of life, Breast-conserving surgery, Intra-operative ultrasonography, Excision volume, Cosmetic outcome, Margin status|
|- Inclusion criteria||1. Women age 25-75 yrs who are diagnosed with palpable early-stage (T1-2N0-1) primary breast cancer in the trial centres. Breast cancer will be diagnosed with physical examination, mammography (2R) and US of the breast and axilla. The diagnosis of invasive (ductal or lobular) breast cancer will be established with image-guided core needle biopsy or cytological puncture;|
2. All patients will be suitable for BCT according to national guidelines;
3. Participants will not have a history of prior mammary surgery in the affected breast, radiation therapy or neo-adjuvant therapy;
4. Participants will have ASA Classification I – III;
5. Participants will be well-informed having signed an informed consent form.
|- Exclusion criteria||1. Participants with a history of prior mamma surgery, radiation therapy or neo-adjuvant therapy;|
2. Patients younger than 25 years;
3. Patients age above 75 years.
|- mec approval received||yes|
|- multicenter trial||yes|
|- Type||2 or more arms, randomized|
|- planned startdate ||1-okt-2010|
|- planned closingdate||1-jul-2011|
|- Target number of participants||120|
|- Interventions||The use of intra-operative ultrasonography in the breast-conserving surgery for palpable breast cancer.
Control: The standard palpation-guided breast-conserving surgery (no use of intra-operative visualisation).
|- Primary outcome||1. Excision volume;|
2. Margin status.
|- Secondary outcome||1. Cosmetic outcome;|
2. Quality of life.
|- Timepoints||The inclusion period will run from October 2010 to July 2011. |
The EORTC QLQ-C30/-BR23 questionnaire will be completed by the patient prior to surgery. Surgery will be scheduled 1-2 weeks after diagnosis.
During a follow-up visit to the outpatient clinic, usually 1-2 weeks after discharge, complications will be recorded and treated.
Three and six months after surgery, information will be collected from each patient concerning the cosmetic outcome and quality of life, and photographs will be taken.
Patients can withdraw from the study at any time during the study period.
|- Trial web site||N/A|
|- status||open: patient inclusion|
|- CONTACT FOR PUBLIC QUERIES|| Nicole M.A. Krekel|
|- CONTACT for SCIENTIFIC QUERIES||Prof. dr. S. Meijer|
|- Sponsor/Initiator ||VU University Medical Center, Dept. of Surgical Oncology|
(Source(s) of Monetary or Material Support)
|- Brief summary||Breast-conserving therapy (BCT) for breast cancer is initiated as a method to preserve healthy breast tissue, thereby improving cosmetic outcomes. The cosmetic outcome after breast cancer surgery is an important determinant of patient satisfaction, maintenance of self-image and quality of life. Thus far, the primary aim of BCT has been focused on achieving tumour-free resection margins and preventing local recurrence, while the cosmetic outcome has been considered less important. Large studies have reported poor cosmetic outcomes in 20-40% of patients after BCT, and the volume of resected breast tissue is the major determinant of the cosmetic outcome. In daily practice, surgical resection of palpable breast cancer is performed with guidance by intra-operative palpation. Concerns about tumour involvement of resection margins, however, often result in unnecessarily wide resection of adjacent healthy breast tissue. Our recent large multicentre retrospective study showed that in 32% (112/351) of patients over 200% excessive healthy breast tissue was excised with the malignant tissue! The mean volume excessively excised was 142 cm³ (64-423 cm³; sd 86)! There is clear evidence for the efficacy of ultrasonography (US) in the resection of nonpalpable tumours, and US is an easy available and feasible method for continuous visualisation during surgery. Intra-operative US reduces the resection of healthy breast tissue and improves tumour-free resection margins. In the present study, the value of the use of US during the resection of palpable tumours of the breast will be investigated. The objectives will be to determine whether US-guided resection of palpable breast cancer allows sparing of the breast tissue while preserving tumour-free resection margins with improvements in cosmetic outcomes and quality of life. |
|- Main changes (audit trail)|
|- RECORD||28-okt-2010 - 7-nov-2010|