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Completed

NCT Number: NCT01496001

Cosmetic and Functional Outcomes After Breast Conserving Surgery

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.

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Key information

Conditions

Breast Cancer Breast Diseases Breast Neoplasms Neoplasms Neoplasms by Site Skin Diseases Skin and Connective Tissue Diseases Unilateral Breast Neoplasms

Age range

Up to 70 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

National Institute of Oncology

Budapest, 1122, Hungary

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Radiotherapy

Other

Adjuvant radiotherapy carried out by institutional protocols.

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.

    Time frame: 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 outcomes

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

    Time frame: 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.

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

    Time frame: 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.

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

    Time frame: 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.

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

    Time frame: 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.

  5. 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.

    Time frame: 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.

  6. Assessing the clinical applicability of the BCCT.core software.

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

National Institute of Oncology, Hungary

Other

Registry information

Official study title

The Effect of Tumor - Breast Volume Ratio on Cosmetic and Functional Outcomes in Breast Conserving Surgery Patients; a Prospective Cohort Study

Important dates

Study start
2011
Primary completion
2015
Study completion
2015
First posted
Dec 21, 2011
Registry last updated
Oct 6, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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