Cosmetic and Functional Outcomes After Breast Conserving Surgery

NCT ID: NCT01496001

Last Updated: 2015-10-06

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 300 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-03-31
• Study Completion Date: 2015-01-31

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.

Conditions

Breast Cancer

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Blinding Strategy: NONE

Study Groups

Cohort

Group Type: EXPERIMENTAL

Lumpectomy, axillary block dissection, breast conserving surgery

Intervention Type: PROCEDURE

Wide excision of primary tumor (using 1 cm surgical margins). Minimally invasive biopsy of the sentinel lymph node.

Radiotherapy

Intervention Type: OTHER

Adjuvant radiotherapy carried out by institutional protocols.

Interventions

Lumpectomy, axillary block dissection, breast conserving surgery

Wide excision of primary tumor (using 1 cm surgical margins). Minimally invasive biopsy of the sentinel lymph node.

Intervention Type: PROCEDURE

Radiotherapy

Adjuvant radiotherapy carried out by institutional protocols.

Intervention Type: OTHER

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

• Maximum Eligible Age: 70 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

National Institute of Oncology, Hungary

OTHER

Sponsor Role: lead

Responsible Party

Dr. Zoltan Matrai

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

National Institute of Oncology

Budapest, , Hungary

Countries

Hungary

Other Identifiers

NIO-BCS-QoL

Identifier Type: -

Identifier Source: org_study_id