Cavity Shaving in Breast Conserving Surgery for Breast Cancer Patients

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

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

Conditions
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Breast Cancer

Intervention / Treatment
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* Procedure: Cavity shaving
* Procedure: Standardized BCS+CM assessment.


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Cavity shaving and CM assessment<br>Standardized BCS with additional cavity shaving before CM assessment. | Procedure: Cavity shaving<br>* 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;<br>Procedure: Standardized BCS+CM assessment.<br>* 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.<br>|
| Placebo Comparator: CM assessment<br>Standardized BCS with CM assessment. | Procedure: Standardized BCS+CM assessment.<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Positivity rate of CMs by intraoperative frozen section analysis. | Proportion of patients with at least one positive(invasive carcinoma or carcinoma in situ, excluding LCIS) CMs on intraoperative frozen section analysis | Completion of surgery for all enrolled patients (approximately 12 months) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Intra-operative rate of suspected/positive CM | 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. | Completion of surgery for all enrolled patients (approximately 12 months) | 
| Rate of intra-operative re-excision for suspected/positive CMs | 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 | Completion of surgery for all enrolled patients (approximately 12 months) | 
| Rate of a second-time surgery for post-operative positive CMs | Positive CMs by post-operative pathological analysis may require a second-time surgery for re-excision. | Completion of surgery for all enrolled patients (approximately 12 months) | 
| Proportion of patients successfully undergone BCT |  | Completion of surgery for all enrolled patients (approximately 12 months) | 
| Cost-effectiveness of cavity shaving in BCS as measured by operative time of the surgery | Surgery time(start from making the incision to closure) will be analyzed. | Completion of surgery for all enrolled patients (approximately 12 months) | 
| Cost-effectiveness of cavity shaving in BCS as measured by medical cost of the surgery | Medical costs will be analyzed. | Completion of surgery for all enrolled patients (approximately 12 months) | 
| Cosmetic outcome | Patients', partners' and physicians' perceptions of the cosmetic outcomes as measured by Harvard/NSABP/RTOG criteria | One year after surgery. | 
| Adverse events |  | One year after surgery. | 
| Quality of life. | Chinese version of validated QLQ-C30 and QLQ-BR23 questionnaire | One year after surgery. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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breast-conserving surgery(BCS), Cavity shave margin, Proportion of positive margins