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TUmour-volume to breast-volume RAtio for Improving COSmetic Results in Breast Cancer Patients (TURACOS); a randomised controlled trial.


- candidate number21693
- NTR NumberNTR4997
- ISRCTNISRCTN no longer applicable
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR17-feb-2015
- Secondary IDsMEC-2013-360  NL44554.078.13
- Public TitleTUmour-volume to breast-volume RAtio for Improving COSmetic Results in Breast Cancer Patients (TURACOS); a randomised controlled trial.
- Scientific TitleTUmour-volume to breast-volume RAtio for Improving COSmetic Results in Breast Cancer Patients (TURACOS); a randomised controlled trial.
- ACRONYMTURACOS
- hypothesisPreoperative use of a prediction model in breast cancer patients, concerning tumour volume versus breast volume ratio and tumour localisation, improves cosmetic results in breast conserving surgery
- Healt Condition(s) or Problem(s) studiedBreast cancer, Breast conserving surgery, Quality of life
- Inclusion criteriaFemale
Primary breast cancer
Pathologically proven breast cancer stage I-III
Aged > 18 years
Eligible for breast conserving surgery (BCS)
- Exclusion criteriaRecurrent breast cancer ipsilateral
Previous radiation therapy ipsilateral breast
- mec approval receivedyes
- multicenter trialyes
- randomisedyes
- masking/blindingNone
- controlNot applicable
- groupParallel
- Type2 or more arms, randomized
- Studytypeintervention
- planned startdate 1-sep-2015
- planned closingdate1-apr-2018
- Target number of participants240
- InterventionsPerforming a three-dimensional ultrasonography to measure tumour volume and breast volume. The volume ratio will be translated using a prediction model aiming for superior cosmetic results in breast cancer patients opting for breast conserving surgery.
- Primary outcomeCosmetic outcome assessed through an independent panel.
- Secondary outcome1) Cosmetic result as assessed by the patient herself, Timepoint; prior to surgery, 2 weeks/3 months/1 year and 3 years after initial surgery.
2) cosmetic result as assessed by an objective asymmetry measurement, Timepoint; 2 weeks/3 months/1 year and 3 years after initial surgery.
3) surgical strategy/strategies performed 2 weeks/3 months/1 year and 3 years after initial surgery.
4) pathological result 2 weeks/3 months/1 year and 3 years after initial surgery.
5) patient satisfaction and 6) quality of life 7) radiation toxicity and 8) cost-effectiveness all will be conducted at Timepoint; 2 weeks/3 months/1 year and 3 years after initial surgery.
- TimepointsInclusion
Randomisation
Follow up T0 - prior to surgery
Follow up T1 - 2 weeks after initial surgery
Follow up T2 - 3 months after initial surgery
Follow up T3 - 1 year after initial surgery
Follow up T4 - 3 year after initial surgery/end of study
- Trial web siteNot applicable
- statusopen: patient inclusion
- CONTACT FOR PUBLIC QUERIESDr. MD, PhD L.B. Koppert,
- CONTACT for SCIENTIFIC QUERIESDr. MD, PhD L.B. Koppert,
- Sponsor/Initiator Erasmus Medical Center, Daniel den Hoed Cancer Center , Erasmus Medical Center, Department of Surgery
- Funding
(Source(s) of Monetary or Material Support)
Stichting Theia, Noordwijk, Stichting Coolsingel, PEM; Speur- En ontwikkelingswerk op het gebied van gezondheid en voeding (niet biotechnologisch)
- PublicationsVos EL, Koning AHJ, Obdeijn I-M, van Verschuer VMT, Verhoef C, van der Spek PJ, Menke-Pluijmers MB, Koppert LB. Preoperative prediction of cosmetic results in breast conserving surgery. J Surg Oncol. 2014:n/a-n/a.
- Brief summaryLong-term survival, recurrence rates and cosmetic result are important endpoints after breast conserving surgery (BCS) in breast cancer patients. Previous studies show that breast conserving surgery followed by radiation therapy is as safe, considering long-term survival and local recurrence rates, as mastectomy in breast cancer patients. Preoperative tools to predict good cosmetic outcome are not yet well established. We proved that tumour location and tumour volume versus breast volume ratio are independent predictors of a good cosmetic result when opting for breast conserving surgery. A prediction model based on these independent predictors and the quality of life in breast cancer patients followed by either breast conserving surgery or mastectomy (with or without direct reconstruction) will be tested in this study. Patients will randomly be assigned to either the intervention or the control group. All participants will undergo a preoperative three-dimensional ultrasonography to assess tumour- and breast-volume. In the intervention group the tumour volume and breast volume will be used for the prediction model. In the control group the three-dimensional ultrasonography will be calculated after inclusion of all participants. Taken the results of the prediction model in account a final decision will be made between breast conserving surgery or mastectomy (followed by direct reconstruction), aiming for the best cosmetic result. An expert panel will, based on medical photographs, assess cosmetic outcome after BCS, primary outcome of the study. Secondary outcomes Quality of Life and psychosocial functioning will be measured with the EORTC and BREAST-Q questionnaire respectively. Other secondary outcome parameters concern pathological results, cost-effectiveness, radiation effects and cosmetic outcome as assessed by the BCCT.core software program. Patientsí last follow up within the study will be 3 years after initial surgery. In summary, this study aims to improve cosmetic outcome following BCS in breast cancer patients by using a preoperative prediction model. By improving cosmetic outcome following BCS it is targeted to increase quality of life and psychosocial functioning in breast cancer patients.
- Main changes (audit trail)
- RECORD17-feb-2015 - 18-okt-2015


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