Cosmetic and Functional Outcomes After Breast Conserving Surgery

Not Applicable

Completed

• Conditions: Breast Cancer
• Interventions: Procedure: Lumpectomy, axillary block dissection, breast conserving surgery; Other: Radiotherapy

• Registration Number: NCT01496001
• Lead Sponsor: National Institute of Oncology, Hungary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2011-03
• Study First Submitted: 2011-12-12
• Study First Submitted QC: 2011-12-20
• Study First Posted: 2011-12-21
• Primary Completion: 2015-01
• Study Completion: 2015-01
• Status Verified: 2015-10
• Last Update Submitted: 2015-10-05
• Last Update Posted: 2015-10-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 300

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Cohort	Lumpectomy, axillary block dissection, breast conserving surgery	-
Cohort	Radiotherapy	-

Primary Outcome Measures

Name	Time	Method
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.	8 months	Data of eligible patients are recorded by the study physicians on a locally developed questionnaire. Digital photos are taken of each patient producing a frontal and two side views. Images are processed by the BCCT.core software (Breast Cancer Conservation Treatment. cosmetic results). Magnetic resonance imaging is implemented and used to calculate breast volume with the help of Amira 5.1 software (Visage Imaging GmbH)trial version.; Excised tumor is measured by a validated analytical scale.

Secondary Outcome Measures

Name	Time	Method
Assessing the effect of radiotherapeutical intervention on cosmetic+functional results and quality of life.	During 8 postoperative months	Initial cosmetic and functional status is recorded by using the validated BCTOS and the BCCT.core software.; Initial quality of life is assessed by the validated EORTC QoL C30-BR23. Patients then undergo surgical procedure according to institutional protocols. On the 4th postoperative week, patients status is recorded by BCTOS, BCTOS.core, EORTC QoL C30-BR23. After adjuvant radiotherapy (according to institutional protocols), in the 8th postoperative month, cosmetic and functional status and quality of life are assessed again with the same methods, and MR images are taken.
Assessing the relationship between cosmetic+functional results and quality of life.	8 months for each patient	Initial cosmetic and functional status is recorded by using the validated BCTOS and the BCCT.core software.; Initial quality of life is assessed by the validated EORTC QoL C30-BR23. Patients then undergo surgical procedure according to institutional protocols. On the 4th postoperative week, patients status is recorded by BCTOS, BCTOS.core, EORTC QoL C30-BR23. After adjuvant radiotherapy (according to institutional protocols), in the 8th postoperative month, cosmetic and functional status and quality of life are assessed again with the same methods, and MR images are taken.
Assessing the clinical applicability of the Breast Cancer Treatment Outcome Scale (BCTOS).	8 months for each patient	Initial cosmetic and functional status is recorded by using the validated BCTOS and the BCCT.core software.; Patients then undergo surgical procedure according to institutional protocols. On the 4th postoperative week, patients status is recorded by BCTOS, BCTOS.core, EORTC QoL C30-BR23. After adjuvant radiotherapy (according to institutional protocols), in the 8th postoperative month, cosmetic and functional status and quality of life are assessed again with the same methods, and MR images are taken.
Assessing the clinical applicability of the BCCT.core software.	8 months	Initial cosmetic and functional status is recorded by using the validated BCTOS and the BCCT.core software.; Patients then undergo surgical procedure according to institutional protocols. On the 4th postoperative week, patients status is recorded by BCTOS, BCTOS.core, EORTC QoL C30-BR23. After adjuvant radiotherapy (according to institutional protocols), in the 8th postoperative month, cosmetic and functional status and quality of life are assessed again with the same methods, and MR images are taken.
Assessing the effect of surgical intervention on cosmetic+functional results and quality of life.	During 8 postoperative months	Initial cosmetic and functional status is recorded by using the validated BCTOS and the BCCT.core software.; Initial quality of life is assessed by the validated EORTC QoL C30-BR23. Patients then undergo surgical procedure according to institutional protocols. On the 4th postoperative week, patients status is recorded by BCTOS, BCTOS.core, EORTC QoL C30-BR23. After adjuvant radiotherapy (according to institutional protocols), in the 8th postoperative month, cosmetic and functional status and quality of life are assessed again with the same methods, and MR images are taken.
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.	8 months	Initial quality of life is assessed by the validated EORTC QoL C30-BR23. Patients then undergo surgical procedure according to institutional protocols. On the 4th postoperative week, patients status is recorded by BCTOS, BCTOS.core, EORTC QoL C30-BR23. After adjuvant radiotherapy (according to institutional protocols), in the 8th postoperative month, cosmetic and functional status and quality of life are assessed again with the same methods, and MR images are taken.

Trial Locations

Locations (1)

National Institute of Oncology; 🇭🇺 Budapest, Hungary