Cosmetic and Functional Outcomes After Breast Conserving Surgery

NCT01496001 | Completed DMC

• 1 other identifier: NIO-BCS-QoL
• Study Type: interventional
• Target: 300
• Locations: 1 country
• Sites: 1

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

Keywords

Early unilateral breast cancer

Outcome Measures

Primary Outcomes (1)

• 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.

  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.

  8 months

Secondary Outcomes (6)

• Assessing the clinical applicability of the Breast Cancer Treatment Outcome Scale (BCTOS).

  8 months for each patient

• Assessing the relationship between cosmetic+functional results and quality of life.

  8 months for each patient

• Assessing the effect of surgical intervention on cosmetic+functional results and quality of life.

  During 8 postoperative months

• Assessing the effect of radiotherapeutical intervention on cosmetic+functional results and quality of life.

  During 8 postoperative months

• 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

Study Arms (1)

Cohort

EXPERIMENTAL

Procedure: Lumpectomy, axillary block dissection, breast conserving surgery; Other: Radiotherapy

Interventions

Lumpectomy, axillary block dissection, breast conserving surgery PROCEDURE

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

Cohort

Radiotherapy OTHER

Adjuvant radiotherapy carried out by institutional protocols.

Cohort

Eligibility Criteria

• Age: Up to 70 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• National Institute of Oncology, Hungary: lead

Study Sites (1)

National Institute of Oncology

Budapest, 1122, Hungary

Location

MeSH Terms

Conditions

Breast Neoplasms; Unilateral Breast Neoplasms

Interventions

Mastectomy, Segmental; Radiotherapy

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Mastectomy; Surgical Procedures, Operative; Therapeutics

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: December 12, 2011
• First Posted: December 21, 2011
• Study Start: March 1, 2011
• Primary Completion: January 1, 2015
• Study Completion: January 1, 2015
• Last Updated: October 6, 2015

Record last verified: 2015-10

Locations

HU (1)