Clinical trial NCT02648802: Cavity Shaving in Breast Conserving Surgery for Breast Cancer Patients
Official title: Cavity Shaving in Breast Conserving Surgery With Intraoperative Cavity Margin Assessment: A Single Center,Randomized,Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Breast Cancer
Keywords: breast-conserving surgery(BCS)
Cavity shave margin
Proportion of positive margins
Lead sponsor: Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
Sponsor class: OTHER
First posted: 2016-01-07
Enrollment: 181
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Positivity rate of CMs by intraoperative frozen section analysis.
timeFrame: Completion of surgery for all enrolled patients (approximately 12 months)
Secondary outcomes:
measure: Intra-operative rate of suspected/positive CM
timeFrame: Completion of surgery for all enrolled patients (approximately 12 months)
measure: Rate of intra-operative re-excision for suspected/positive CMs
timeFrame: Completion of surgery for all enrolled patients (approximately 12 months)
measure: Rate of a second-time surgery for post-operative positive CMs
timeFrame: Completion of surgery for all enrolled patients (approximately 12 months)
measure: Proportion of patients successfully undergone BCT
timeFrame: Completion of surgery for all enrolled patients (approximately 12 months)
measure: Cost-effectiveness of cavity shaving in BCS as measured by operative time of the surgery
timeFrame: Completion of surgery for all enrolled patients (approximately 12 months)
measure: Cost-effectiveness of cavity shaving in BCS as measured by medical cost of the surgery
timeFrame: Completion of surgery for all enrolled patients (approximately 12 months)
measure: Cosmetic outcome
timeFrame: One year after surgery.
measure: Adverse events
timeFrame: One year after surgery.
measure: Quality of life.
timeFrame: One year after surgery.
Other outcomes:
measure: Volume of cavity shaving tissue.
timeFrame: Completion of surgery for all enrolled patients (approximately 12 months)
measure: Weight of cavity shaving tissue.
timeFrame: Completion of surgery for all enrolled patients (approximately 12 months)
measure: Relationship between the volume of tissue excised in association aesthetic outcomes
timeFrame: Completion of surgery for all enrolled patients (approximately 12 months)
measure: Risk factors for positive CMs
timeFrame: Completion of surgery for all enrolled patients (approximately 12 months)
Locations:
city: Guangzhou
country: China
facility: Sun-Yat-Sen Memorial Hospital of Sun-Yat-Sen University
state: Guangdong
Study officials:
affiliation: Breast Tumor Center, Sun Yat-sen Memorial Hospital, Sun Yat-sen University.
name: Fengxi Su, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
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citation: 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.
citation: 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.