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NCT Number: NCT02648802

Cavity Shaving in Breast Conserving Surgery for Breast Cancer Patients

This randomized controlled trial is to evaluate the impact of additional cavity shaving (CS) on pathological cavity margin (CM) status in breast cancer patients. Patients receiving standard breast-conserving surgery (BCS) will be randomized to intra-operative CM assessment versus intra-operative CS followed by CM assessment. The primary objective of this study is to assess the impact of CS on intra-operative CM status, intra-operative re-excision rate, post-operative CM status and re-excision rate, cosmetic outcomes, and on intraoperative time and medical costs.

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Key information

Conditions

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

Age range

18 year–65 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Sun-Yat-Sen Memorial Hospital of Sun-Yat-Sen University

Guangzhou, Guangdong, 510120, China

About this study

After stratified and blocked randomization, the patients' name, admission ID and treatment assignment will be written on a slip of paper, and will be placed in a sealed envelop. A label with the patients' name and admission ID will be placed on the sealed envelop, which will be kept in a locked file. On the day of surgery, a research coordinator will bring the sealed envelope to the operation room. During the standard-of-care BCS, the tumor was excised with a rim of grossly normal tissue. Additional resections are allowed when any of the margins of the tumor-containing specimen were suspected to be inadequate on the basis of standard gross evaluation by surgeons. Prior to intra-operative CM assessment, the research co-ordinator will unseal the envelop and determine which procedure has been designated to the patient. The cosmetic outcome and the quality of life will be evaluated at the day of discharge, after completion of radiotherapy and one year by the patient herself, her partner and a research co-ordinator.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Female
  • At least 18 years of age and no more than 65 years of age
  • Able to understand and willing to sign an informed consent document
  • Willing and planning to undergo the breast-conserving surgery
  • ECOG≤ 2

Exclusion criteria

  • Inflammatory breast cancer
  • Preference for mastectomy instead of breast-conserving surgery
  • Necessity to undergo oncoplastic breast surgery
  • Prior surgical treatment, including ultrasound-guided vacuum-assisted biopsy and excision biopsy.
  • Prior systemic therapy for this diagnosis, including neoadjuvant chemotherapy, neoadjuvant endocrine therapy.
  • History of prior breast/axillary radiation therapy
  • Known metastatic disease
  • Diagnosed as bilateral breast cancer or DCIS
  • History of other malignancy ≤ 5 years previous
  • Preoperation evaluation indicates tumor size>5cm
  • Preoperation evaluation indicates multicenter or multifocal breast cancer(including suspicious calcification on mammography)
  • Undergoing other clinical trials
  • With sever liver disfunction(Child-Pugh C)
  • With sever cardiac insufficiency
  • With sever renal disfunction
  • Pregnancy

Treatment and study plan

Cavity shaving

Procedure

Resect the residual cavity circumferentially (superior, inferior, medial, lateral) and the thickness of the cavity shaving depends on the surgeon's discretion (Recommended 0.5-1.0cm). The principles of the cavity shaving includes: 1) do not compromise the cosmetic outcomes; 2) covers the entire cavity;

Standardized BCS+CM assessment.

Procedure

For standardized BCS(Chen K, et al. Ann Surg Oncol. 2012), we resect a rim of 1 cm macroscopically normal tissue around the tumor. The anterior and posterior margins of the tumor-containing specimen extended up to the subdermal plane of the skin and down to the pectoralis major fascia, respectively. The anterior and posterior CMs assessment will not be needed. A surgical blade was used for resecting the CMs (superior, inferior, medial and lateral) to render the thickness of the CMs as thin as possible. No procedures were required for distinguishing the inner and outer surface. They were then frozen and cut parallel, but not perpendicular to the largest surface area. CMs were defined as positive when in situ or invasive carcinoma was found intraoperatively by frozen-section analysis.

Primary outcomes

  1. Positivity rate of CMs by intraoperative frozen section analysis.

    Time frame: Completion of surgery for all enrolled patients (approximately 12 months)

    Proportion of patients with at least one positive(invasive carcinoma or carcinoma in situ, excluding LCIS) CMs on intraoperative frozen section analysis

Secondary outcomes

  1. Intra-operative rate of suspected/positive CM

    Time frame: Completion of surgery for all enrolled patients (approximately 12 months)

    Proportion of patients with at least one positive(invasive carcinoma or carcinoma in situ, excluding LCIS) or suspected CMs on intraoperative frozen section analysis. Suspected CMs were defined as CMs with severe atypical hyperplasia observed by frozen section analysis.

  2. Rate of intra-operative re-excision for suspected/positive CMs

    Time frame: Completion of surgery for all enrolled patients (approximately 12 months)

    For patients with positive CMs, intra-operative re-excision was required. For patients with suspected CMs,intra-operative re-excision is left to the surgeon's discretion

  3. Rate of a second-time surgery for post-operative positive CMs

    Time frame: Completion of surgery for all enrolled patients (approximately 12 months)

    Positive CMs by post-operative pathological analysis may require a second-time surgery for re-excision.

  4. Proportion of patients successfully undergone BCT

    Time frame: Completion of surgery for all enrolled patients (approximately 12 months)

  5. Cost-effectiveness of cavity shaving in BCS as measured by operative time of the surgery

    Time frame: Completion of surgery for all enrolled patients (approximately 12 months)

    Surgery time(start from making the incision to closure) will be analyzed.

  6. Cost-effectiveness of cavity shaving in BCS as measured by medical cost of the surgery

    Time frame: Completion of surgery for all enrolled patients (approximately 12 months)

    Medical costs will be analyzed.

  7. Cosmetic outcome

    Time frame: One year after surgery.

    Patients', partners' and physicians' perceptions of the cosmetic outcomes as measured by Harvard/NSABP/RTOG criteria

  8. Adverse events

    Time frame: One year after surgery.

  9. Quality of life.

    Time frame: One year after surgery.

    Chinese version of validated QLQ-C30 and QLQ-BR23 questionnaire

Other outcomes

  1. Volume of cavity shaving tissue.

    Time frame: Completion of surgery for all enrolled patients (approximately 12 months)

    Water displacement method was used to measure the volume of the tissue resected by cavity shaving.

  2. Weight of cavity shaving tissue.

    Time frame: Completion of surgery for all enrolled patients (approximately 12 months)

  3. Relationship between the volume of tissue excised in association aesthetic outcomes

    Time frame: Completion of surgery for all enrolled patients (approximately 12 months)

    Volume of the excised tissue, including the tumor-containing specimen will be analyzed.

  4. Risk factors for positive CMs

    Time frame: Completion of surgery for all enrolled patients (approximately 12 months)

Sponsors and collaborators

Lead sponsor

Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University

Other

Registry information

Official study title

Cavity Shaving in Breast Conserving Surgery With Intraoperative Cavity Margin Assessment: A Single Center,Randomized,Controlled Trial

Important dates

Study start
2016
Primary completion
2018
Study completion
2019
First posted
Jan 7, 2016
Registry last updated
Aug 22, 2019

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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