Prospective Non-randomized Evaluation of Oncoplastic Surgery (iTOP)

This study is currently recruiting participants.
Verified April 2011 by Medical University of Vienna
Sponsor:
Information provided by:
Medical University of Vienna
ClinicalTrials.gov Identifier:
NCT01396993
First received: July 18, 2011
Last updated: NA
Last verified: April 2011
History: No changes posted
  Purpose

Breast conserving therapy (BCT) is the standard treatment for intraductal or invasive breast cancer patients. However cosmetic results, e.g. symmetry and nipple displacement, are sometimes poor reducing the quality of life. The use of immediate techniques for oncoplastic surgery (iTOP) seems to improve subjective cosmetic outcome. Oncologic safety of iTOP has been demonstrated by several authors using restrospective analyses. However, no prospective observational trial has been done to objectively evaluate cosmetic and oncologic outcome comparing BCT with iTOP. The aim of this study is to investigate this issue within a prospective non randomized observational trial at the Medical University Vienna.


Condition Intervention
Breast Image Scale Index for Self Esteem Evaluation
Breast Symmetry Index
Quality of Life
Morbidity
Oncological Outcome
Procedure: Breast Surgery

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Prospective Trial Evaluating Cosmetic And Oncologic Outcome Of Immediate Techniques For Oncoplastic Surgery In Breast Cancer

Resource links provided by NLM:


Further study details as provided by Medical University of Vienna:

Primary Outcome Measures:
  • breast image scale [ Time Frame: 2 years ] [ Designated as safety issue: No ]
    self esteem measured by the breast image scale will be assessed before and every 6 months after surgery as primary endpoint.


Secondary Outcome Measures:
  • quality of life [ Time Frame: 2 years ] [ Designated as safety issue: No ]
    BREAST Q, non-validated questionnaires

  • Morbidity [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]
    Necrosis, infection, reoperations and bleedings as well as heamtoma and seroma formation will be clinically assessed after surgery

  • breast symmetry index [ Time Frame: 2 years ] [ Designated as safety issue: No ]
    Using the breast analyzing tool software we will analyze breast symmetry before and every 6 months after surgery

  • oncologic parameters [ Time Frame: 2-5 years ] [ Designated as safety issue: Yes ]
    local, distent and overal survival 2 as well as 5 years after surgery will be assessed


Estimated Enrollment: 300
Study Start Date: July 2011
Estimated Study Completion Date: July 2016
Estimated Primary Completion Date: July 2013 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
iTOP
Patients undergoing immediate techniques for oncoplastic surgery (level I only parenchmyl rotation and breast undermining as well as level II using complex reduction plastics for nipple-areola-complex movings) and patients with mastectomy and immediate reconstruction
Procedure: Breast Surgery
breast conserving surgery AND immediate defect filling using local flaps (level I) or reduction plastics (level II) as well as mastectomy and immediate reconstruction using free flaps
BCT
patients undergoing conservative breast surgery
Procedure: Breast Surgery
Breast conserving therapy without defect correction

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

Patients with a BIRADS IV, V or VI breast lesion are preoperatively asked to take part in this study if more than 10% of breast tissue will be excised or mastectomy and immediate reconstruction is planned. Patients with planned mastectomy without immediate reconstruction are not included. Patients scheduled for breast conservation can decide whether they undergo regular breast conservation (BCT) or BCT using immediate techniques of oncoplastic surgery (iTOP). A contralateral correction may be performed in both groups at any time of the trial. The use of a contralateral correction of patients without an immediate oncoplastic procedure does not initiate a change into the other group (intention to treat analyses).

Criteria

Inclusion Criteria:

  • Patients scheduled for unilateral breast conserving surgery due to cancer or a suspicious lesion, in whom >10%* of breast volume (measured by mammograms using a defined formular 37) has to be removed or breast cancer patients scheduled for mastectomy and immediate reconstruction (immediate or delayed contralateral correction is allowed)
  • BIRADS IV, V or VI are eligible
  • > 18 years of age
  • Psychological and physical capable of understanding and performing the trial
  • Signed written informed consent * If oncologic safety necessitates to resect more than half of one breast quadrant

Exclusion Criteria:

  • Inflammatory breast cancer
  • Progression after neoadjuvant therapy
  • Pregnant women
  • Patients unable to perform surgery under general anaesthesia
  • Bilateral breast lesions
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01396993

Locations
Austria
Medical University Vienna Recruiting
Vienna, Austria, 1090
Contact: Florian Fitzal, MD FEBS    +43 1 40400 ext 5621    florian.fitzal@meduniwien.ac.at   
Principal Investigator: Florian Fitzal, MD FEBS         
Sponsors and Collaborators
Medical University of Vienna
  More Information

No publications provided

Responsible Party: Florian Fitzal, MD FEBS, Medical University Vienna
ClinicalTrials.gov Identifier: NCT01396993     History of Changes
Other Study ID Numbers: iTOP
Study First Received: July 18, 2011
Last Updated: July 18, 2011
Health Authority: Austria: Ethikkommission

ClinicalTrials.gov processed this record on April 15, 2014