| CTRI Number |
CTRI/2017/11/010589 [Registered on: 22/11/2017] Trial Registered Retrospectively |
| Last Modified On: |
23/11/2015 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Incidence of tumour cells in lymphatics as effect of breast conservation surgery for breast cancer patinets |
|
Scientific Title of Study
|
Randomized Controlled Trial to Evaluate the Role of Iatrogenic Displacement of Tumor cells to Axillary Lymph Nodes. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Rajendra A Badwe |
| Designation |
Professor of Surgical Oncology and Director Tata Memorial Centre Mumbai |
| Affiliation |
Tata Memorial Centre |
| Address |
Tata Memorial Hospital Dr Ernest Borges Marg Parel Mumbai India
Mumbai
MAHARASHTRA
400012
India |
| Phone |
91-22-24177000 |
| Fax |
91-22-24154005 |
| Email |
badwera@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Mihir Chandarana |
| Designation |
Senior Resident I MCh Surgical Oncology |
| Affiliation |
Tata Memorial Hospital |
| Address |
Tata Memorial Hospital Dr Ernest Borges MargParel MumbaiIndia
Mumbai
MAHARASHTRA
400012
India |
| Phone |
9619576963 |
| Fax |
91-22-24154005 |
| Email |
drmihirchandarana@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Mihir Chandarana |
| Designation |
Senior Resident I MCh Surgical Oncology |
| Affiliation |
Tata Memorial Hospital |
| Address |
Tata Memorial Hospital Dr Ernest Borges MargParel MumbaiIndia
Mumbai
MAHARASHTRA
400012
India |
| Phone |
9619576963 |
| Fax |
91-22-24154005 |
| Email |
drmihirchandarana@gmail.com |
|
|
Source of Monetary or Material Support
|
| Tata Memorial Hospital
Dr Ernest Borges Road
Parel, Mumbai 400012 |
|
|
Primary Sponsor
|
| Name |
Tata Memorial Hospital |
| Address |
Tata Memorial Hospital, Dr E Borges Road,Parel, Mumbai, India |
| 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 R A Badwe |
Tata Memorial Hospital |
Room No 103-104, Breast OPD
First Floor HBB
Mumbai
MAHARASHTRA |
91-22-24177000
91-22-24154005
badwera@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee Tata Memorial Hospital Mumbai |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
Operable Breast Cancer Female patient, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Axilla First appproach arm |
Patient in the axilla first approach arm will undergo an axillary sampling and clearance first followed by a wide local excision for the primary breast tumor. |
| Comparator Agent |
Breast First approach arm |
Patient in breast first approach arm will undergo a wide local excision of the primary breast tumor followed by an axillary sampling and clearance performed by separate skin incision in axilla |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Female |
| Details |
1.Female patient with breast cancer age 18 years and above
2.T1 N0 / T2 N0 tumours
3.Patient undergoing upfront breast conserving surgery
4.Willing to give consent to participate in the study
|
|
| ExclusionCriteria |
| Details |
1.Previous h/o lumpectomy or incision biopsy
2.Patient planned for Neoadjuvant Chemotherapy
3.Locally advanced or metastatic breast tumours
4.Lactating patients
|
|
|
Method of Generating Random Sequence
|
Stratified block randomization |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To study the incidence of Iatrogenic Displacement of Tumor Cells in afferent lymphatics as a consequence of tumor handling |
30 days after surgery |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1.To study the incidence of micrometastases in afferent lymphatics as a consequence of tumor handling
|
From the day of surgery to post operative Day 15 |
| 2.To study the impact of ITCs on disease free survival |
5 years |
|
|
Target Sample Size
|
Total Sample Size="700"
Sample Size from India="700"
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
|
Phase 3 |
|
Date of First Enrollment (India)
|
05/02/2014 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="3"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Closed to Recruitment of Participants |
|
Publication Details
|
None yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
Rationale: Axillary nodal status in patients with carcinoma of the
breast is one of the strongest prognostic factors and also an important
determinant on decisions for
adjuvant treatment. The role of isolated tumor cells (ITCs) and circulating
tumor cells (CTCs) and their clinical significance remains to be established.
Studies have shown that tumor manipulation causes an increase in the CTCs. A
population-based study from Denmark has shown an increase in the ITCs in the
axillary nodes secondary to tumor handling. Prospective data on the same are
lacking. We aim to study if tumor manipulation causing increased ITC.
Methodology: The trial is a Randomized controlled trial in
patients of breast carcinoma presenting with clinically negative nodes,
eligible for breast conservation surgery. Patients will be randomized into two
groups, namely axilla first or primary first.
The protocol would not impact the overall treatment plan of the
patients, or have a bearing on the cost of treatment. The detection of the ITCs
would require additional immune-histochemistry studies, for which funding would
be required |