Cavity Shaving in Breast Conserving Surgery for Breast Cancer Patients

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

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.

Study Overview

• Status: Completed
• Conditions: Breast Cancer
• Intervention / Treatment: Procedure: Cavity shaving; Procedure: Standardized BCS+CM assessment.

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Actual): 181
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Guangdong
    • Guangzhou, Guangdong, China, 510120
      • Sun-Yat-Sen Memorial Hospital of Sun-Yat-Sen University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

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.

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Volume of cavity shaving tissue.	Water displacement method was used to measure the volume of the tissue resected by cavity shaving.	Completion of surgery for all enrolled patients (approximately 12 months)
Weight of cavity shaving tissue.		Completion of surgery for all enrolled patients (approximately 12 months)
Relationship between the volume of tissue excised in association aesthetic outcomes	Volume of the excised tissue, including the tumor-containing specimen will be analyzed.	Completion of surgery for all enrolled patients (approximately 12 months)
Risk factors for positive CMs		Completion of surgery for all enrolled patients (approximately 12 months)

Collaborators and Investigators

• Sponsor: Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
• Investigators: Principal Investigator: Fengxi Su, M.D., Breast Tumor Center, Sun Yat-sen Memorial Hospital, Sun Yat-sen University.

Publications and helpful links

General Publications

• Fisher B, Anderson S, Bryant J, Margolese RG, Deutsch M, Fisher ER, Jeong JH, Wolmark N. Twenty-year follow-up of a randomized trial comparing total mastectomy, lumpectomy, and lumpectomy plus irradiation for the treatment of invasive breast cancer. N Engl J Med. 2002 Oct 17;347(16):1233-41. doi: 10.1056/NEJMoa022152.
• Veronesi U, Cascinelli N, Mariani L, Greco M, Saccozzi R, Luini A, Aguilar M, Marubini E. Twenty-year follow-up of a randomized study comparing breast-conserving surgery with radical mastectomy for early breast cancer. N Engl J Med. 2002 Oct 17;347(16):1227-32. doi: 10.1056/NEJMoa020989.
• Moran MS, Schnitt SJ, Giuliano AE, Harris JR, Khan SA, Horton J, Klimberg S, Chavez-MacGregor M, Freedman G, Houssami N, Johnson PL, Morrow M. Society of Surgical Oncology-American Society for Radiation Oncology consensus guideline on margins for breast-conserving surgery with whole-breast irradiation in stages I and II invasive breast cancer. Int J Radiat Oncol Biol Phys. 2014 Mar 1;88(3):553-64. doi: 10.1016/j.ijrobp.2013.11.012.
• Morrow M, Jagsi R, Alderman AK, Griggs JJ, Hawley ST, Hamilton AS, Graff JJ, Katz SJ. Surgeon recommendations and receipt of mastectomy for treatment of breast cancer. JAMA. 2009 Oct 14;302(14):1551-6. doi: 10.1001/jama.2009.1450.
• Cendan JC, Coco D, Copeland EM 3rd. Accuracy of intraoperative frozen-section analysis of breast cancer lumpectomy-bed margins. J Am Coll Surg. 2005 Aug;201(2):194-8. doi: 10.1016/j.jamcollsurg.2005.03.014.
• Chagpar AB, Killelea BK, Tsangaris TN, Butler M, Stavris K, Li F, Yao X, Bossuyt V, Harigopal M, Lannin DR, Pusztai L, Horowitz NR. A Randomized, Controlled Trial of Cavity Shave Margins in Breast Cancer. N Engl J Med. 2015 Aug 6;373(6):503-10. doi: 10.1056/NEJMoa1504473. Epub 2015 May 30.
• Kayar R, Civelek S, Cobanoglu M, Gungor O, Catal H, Emiroglu M. Five methods of breast volume measurement: a comparative study of measurements of specimen volume in 30 mastectomy cases. Breast Cancer (Auckl). 2011 Mar 27;5:43-52. doi: 10.4137/BCBCR.S6128.
• Chen K, Zeng Y, Jia H, Jia W, Yang H, Rao N, Song E, Cox CE, Su F. Clinical outcomes of breast-conserving surgery in patients using a modified method for cavity margin assessment. Ann Surg Oncol. 2012 Oct;19(11):3386-94. doi: 10.1245/s10434-012-2331-5. Epub 2012 Apr 10.
• Chen K, Zhu L, Chen L, Li Q, Li S, Qiu N, Yang Y, Su F, Song E. Circumferential Shaving of the Cavity in Breast-Conserving Surgery: A Randomized Controlled Trial. Ann Surg Oncol. 2019 Dec;26(13):4256-4263. doi: 10.1245/s10434-019-07725-w. Epub 2019 Aug 19.

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2016
• Primary Completion (Actual): November 1, 2018
• Study Completion (Actual): August 20, 2019

Study Registration Dates

• First Submitted: January 3, 2016
• First Submitted That Met QC Criteria: January 5, 2016
• First Posted (Estimate): January 7, 2016

Study Record Updates

• Last Update Posted (Actual): August 22, 2019
• Last Update Submitted That Met QC Criteria: August 21, 2019
• Last Verified: August 1, 2019

More Information

Terms related to this study

• Keywords: breast-conserving surgery(BCS); Cavity shave margin; Proportion of positive margins
• Additional Relevant MeSH Terms: Skin Diseases; Neoplasms; Neoplasms by Site; Breast Diseases; Breast Neoplasms
• Other Study ID Numbers: CSBCS1

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Yes
• IPD Plan Description: The de-identified individual participant data will be available after the research paper has been published.