| CTRI Number |
CTRI/2024/12/077661 [Registered on: 04/12/2024] Trial Registered Prospectively |
| Last Modified On: |
03/12/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Cohort Study |
| Study Design |
Other |
|
Public Title of Study
|
Comparison of Oncoplastic and Conventional breast surgery |
|
Scientific Title of Study
|
Comparison of Oncological and Cosmetic Outcomes in patients undergoing Oncoplastic vs Conventional (non-Oncoplastic) Breast Conservation Surgery |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Gaurav Agarwal |
| Designation |
Professor |
| Affiliation |
SGPGI |
| Address |
Department of Endocrine Surgery, SGPGI Lucknow
Lucknow UTTAR PRADESH 226014 India |
| Phone |
8004904646 |
| Fax |
|
| Email |
gaurav@agpgi.ac.in |
|
Details of Contact Person Scientific Query
|
| Name |
Gaurav Agarwal |
| Designation |
Professor |
| Affiliation |
SGPGI |
| Address |
Department of Endocrine Surgery, SGPGI Lucknow
Lucknow UTTAR PRADESH 226014 India |
| Phone |
8004904646 |
| Fax |
|
| Email |
gaurav@agpgi.ac.in |
|
Details of Contact Person Public Query
|
| Name |
Mithlesh Wanchoo |
| Designation |
Senior Resident |
| Affiliation |
SGPGI |
| Address |
Department of Endocrine Surgery, SGPGI Lucknow
Lucknow UTTAR PRADESH 226014 India |
| Phone |
9419255052 |
| Fax |
|
| Email |
drmithleshw@gmail.com |
|
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Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
SGPGI LUCKNOW |
| Address |
Rae barelli road, Lucknow - 226014 |
| Type of Sponsor |
Research institution and hospital |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Mithlesh wanchoo |
SGPGI |
Department of Endocrine Surgery, SGPGI Lucknow Lucknow UTTAR PRADESH |
9419255052
drmithleshw@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| IEC, SGPGI, Lucknow |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: C50||Malignant neoplasm of breast, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
NIL |
NIL |
| Comparator Agent |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
0.00 Year(s) |
| Age To |
90.00 Year(s) |
| Gender |
Female |
| Details |
1 Female patients diagnosed with early breast cancer (EBC) or locally advanced breast cancer (LABC) who have undergone breast conservation surgery at SGPGIMS.
2 Patients who are candidates for breast-conserving surgery (BCS), either as primary surgery or after neoadjuvant chemotherapy (NACT).
3 Patients who consent to participate in the study and complete the required questionnaires.
|
|
| ExclusionCriteria |
| Details |
•Patients with Metastatic Breast cancer
•Patients requiring mastectomy due to tumor size, multifocality, extensive microcalcifications, or any other clinical factors
•Insufficient data or follow up
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
To compare Margin infiltrating rate (MIR) i.e, positive margins on Frozen section biopsy between both groups
To compare Ipsilateral breast tumor recurrence (IBTR) rate between both groups.
|
At surgery |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To Compare patient satisfaction regarding breast shape, volume, symmetry, scar and overall satisfaction
To compare the re-excision rate between both groups
To estimate Overall Survival (OS) and disease-free survival rates (DFS)
To evaluate rate of conversion to mastectomy between both groups
|
6 months for Patient satisfaction and during follow up period |
|
|
Target Sample Size
|
Total Sample Size="376" Sample Size from India="376"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
14/12/2024 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
14/12/2024 |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="2" Months="0" Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Breast cancer is among the most prevalent malignancies affecting women worldwide. Breast conservation surgery(BCS) is the preferred surgical treatment combined with radiation therapy for eligible early(EBC) and selected locally advanced breast cancer(LABC) patients (1). Achieving sound oncologic outcomes are of paramount importance. Preserving quality of life is pivotal too, with maintaining breast symmetry, shape, contour being crucial objectives. Oncoplastic breast surgery(OPS) techniques are believed to help achieving these goals to greater extent than conventional non-oncoplastic(nOPS) BCS (2). After neoadjuvant chemotherapy (NACT), breast conservation surgery (BCS) remains a safe option even for large tumors and locally advanced breast cancer (LABC), although many patients may require oncoplastic procedures to achieve satisfactory cosmetic results (3). In settings where patients commonly present with large breast cancers or LABC, the benefits of BCS can be extended to a majority, aided by NACT, without compromising cure rates. Performing a post-NACT wide local excision (WLE) that extends beyond the marked pre-NACT margins can result in clear, uninfiltrated margins in 95% of cases. Conversely, relying on post-NACT margins alone to guide WLE may lead to infiltrated margins in 35% of patients, some of which could remain undetected, thereby increasing the risk of local recurrence (4). A novel method using sterile silver wire markers to delineate tumor margins has proven to be a safe, cost-effective, and practical approach, facilitating safe BCS in a substantial proportion of LABC patients. Additionally, the use of intraoperative frozen section histology (IFSH) enables oncologically complete BCS in a single step for most patients, offering significant cost savings by reducing the need for reoperations, and minimizing patient anxiety and delays in adjuvant treatment (5). REFERENCES: 1. Siegel RL, Miller KD, Fuchs HE, Jemal A. Cancer statistics, 2021. CA Cancer J Clin. 2021;71(1):7-33. 2. Morrow M, Li Y, Alderman AK, Jagsi R, Hamilton AS, Graff JJ, et al. Access to breast reconstruction after mastectomy and patient perspectives on reconstruction decision making. JAMA Surg. 2014;149(10):1015-21. 1.
Agarwal G, Sonthineni C, Mayilvaganan S,
Mishra A, Lal P, Agrawal V. Surgical Outcomes of Primary Versus
Post-Neoadjuvant Chemotherapy Breast Conservation Surgery: A Comparative Study
from a Developing Country. World J Surg. 2018 May;42(5):1364-74. 2.
Aggarwal V, Agarwal G, Lal P, Krishnani N,
Mishra A, Verma AK, Mishra SK. Feasibility study of safe breast conservation in
large and locally advanced cancers with use of radiopaque markers to mark
pre-neoadjuvant chemotherapy tumor margins. World J Surg. 2008
Dec;32(12):2562-9.
3.
Agarwal G, Sattavan S, Vishvak Chanthar
KMM, Kumar A, Sabaretnam M, Chand G, Mishra A, Agrawal V. Cost-Efficacy
Analysis of Use of Frozen Section Histology for Margin Assessment During Breast
Conservation Surgery in Breast Cancer Patients. World J Surg. 2023
Oct;47(10):2457-63
|