Clinical trial NCT01496001: Cosmetic and Functional Outcomes After Breast Conserving Surgery
Official title: The Effect of Tumor - Breast Volume Ratio on Cosmetic and Functional Outcomes in Breast Conserving Surgery Patients; a Prospective Cohort Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Breast Cancer
Keywords: Early unilateral breast cancer
Lead sponsor: National Institute of Oncology, Hungary
Sponsor class: OTHER
First posted: 2011-12-21
Enrollment: 300
Sex: FEMALE
Maximum age (years): 70
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP

Brief summary: The initial aesthetic and functional conditions are recorded with the help of the Breast Cancer Treatment Outcome Scale (BCTOS),an international validated questionnaire, and the Breast Cancer Conservative Treatment - cosmetic results (BCCT.core) validated computer software, allowing for comparison. Determination of the initial quality of life is measured with the European Organisation of Research and Treatment of Cancer - Quality of Life Questionnaire number C30-BR23 (EORTC QoL C30-BR23).

Patients then undergo surgical treatment according to institutional protocols. Following conventional marking of the orientation of the specimen, it is measured by an analytical scale.

Histological examination of the specimen will record the largest diameters, and parameters of the lymph nodes, according to the institutional protocol.

On the 4th week following surgery, assuming that wound healing is completed, patients' data are again recorded in BCTOS, BCCT.core and EORTC QoL C30-BR23. A third set of data are gained after completion of adjuvant radiotherapy, on the 8th postoperative month. Magnetic resonance imaging is performed to assess the volume of the contralateral breast.

Tumor - breast volume ratio is calculated, and matched up with cosmetic results in each quadrant, threshold value in the quadrants, above of which it is not advisable to perform conventional breast conserving surgery due to poor outcomes.


Eligibility criteria: Inclusion Criteria:

* early breast cancer
* unilateral tumor
* tumor size is less than 3 cm

Exclusion Criteria:

* age over 70
* malignant invasive tumor in the past
* pregnancy
* previous surgical treatment of the breast or axilla
* central breast tumor sizing \<3 cm
* a need for mastectomy
* tumor size \>3 cm measured by mammography or physical examination
* surgical excisions resulting in positive margins
* surgical or radiotherapeutic complication

Primary outcomes:
measure: Primary outcome is the determination of the critical tumor / breast volume ratio in each quadrant, above of which number breast conserving surgery could not offer adequate cosmetic and functional results.
timeFrame: 8 months
Secondary outcomes:
measure: Assessing the clinical applicability of the Breast Cancer Treatment Outcome Scale (BCTOS).
timeFrame: 8 months for each patient
measure: Assessing the relationship between cosmetic+functional results and quality of life.
timeFrame: 8 months for each patient
measure: Assessing the effect of surgical intervention on cosmetic+functional results and quality of life.
timeFrame: During 8 postoperative months
measure: Assessing the effect of radiotherapeutical intervention on cosmetic+functional results and quality of life.
timeFrame: During 8 postoperative months
measure: Assessing the clinical applicability of the European Organisation of Research and Treatment of Cancer, Quality of Life Questionnaire C30-BR23 (EORTC QoL C30-BR23) validated questionnaire.
timeFrame: 8 months
measure: Assessing the clinical applicability of the BCCT.core software.
timeFrame: 8 months
Other outcomes:
Locations:
city: Budapest
country: Hungary
facility: National Institute of Oncology
Study officials:
References: