| CTRI Number |
CTRI/2024/06/068847 [Registered on: 13/06/2024] Trial Registered Prospectively |
| Last Modified On: |
28/05/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Radiation Therapy |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
A study on the optimal sequencing of radiation In breast cancer(NEOORB) |
|
Scientific Title of Study
|
Neoadjuvant Radiotherapy in breast Cancer, A study on the optimal sequencing of radiation in breast cancer. |
| Trial Acronym |
NeoORB |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Rishi P Nair |
| Designation |
Senior Resident(DM Radiotherapy and Oncology) |
| Affiliation |
All India Institute of Medical Sciences,Jodhpur |
| Address |
Room No 5, Department of Radiation Oncology,Ground floor, All India Institute of Medical Sciences,Marudhar Industrial Area, 2nd Phase, M.I.A. 1st Phase, Basni, Basni, Jodhpur, Rajasthan 342005
Jodhpur
RAJASTHAN
342005
India |
| Phone |
7907283234 |
| Fax |
|
| Email |
rishiprem95@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Puneet Pareek |
| Designation |
Additional Professor and Head of the Department, Department of Radiation Oncology |
| Affiliation |
All India Institute of Medical Sciences,Jodhpur |
| Address |
Room No 4, Department of Radiation Oncology,Ground floor, All India Institute of Medical Sciences,Marudhar Industrial Area, 2nd Phase, M.I.A. 1st Phase, Basni, Basni, Jodhpur, Rajasthan 342005
Jodhpur
RAJASTHAN
342005
India |
| Phone |
8118823077 |
| Fax |
|
| Email |
drpuneetpareek@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Rishi P Nair |
| Designation |
Senior Resident(DM Radiotherapy and Oncology) |
| Affiliation |
All India Institute of Medical Sciences,Jodhpur |
| Address |
Room No 5, Department of Radiation Oncology,Ground floor, All India Institute of Medical Sciences,Marudhar Industrial Area, 2nd Phase, M.I.A. 1st Phase, Basni, Basni, Jodhpur, Rajasthan 342005
Jodhpur
RAJASTHAN
342005
India |
| Phone |
7907283234 |
| Fax |
|
| Email |
rishiprem95@gmail.com |
|
|
Source of Monetary or Material Support
|
| All India Institute of Medical Sciences, Jodhpur |
|
|
Primary Sponsor
|
| Name |
All India Institute of Medical Sciences, Jodhpur |
| Address |
Marudhar Industrial Area, 2nd Phase, M.I.A. 1st Phase, Basni, Basni, Jodhpur, Rajasthan 342005 |
| Type of Sponsor |
Government medical college |
|
|
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 Rishi P Nair |
All India Institute of Medical Sciences, Jodhpur |
Room No 5, Department of Radiation Oncology, Ground Floor,Marudhar Industrial Area, 2nd Phase, M.I.A. 1st Phase, Basni, Jodhpur, Rajasthan 342005
Jodhpur
RAJASTHAN |
7907283234
rishiprem95@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee(Clinical Trial) |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: C509||Malignant neoplasm of breast of unspecified site, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Preoperative radiotherapy in breast cancer after neoadjuvant chemotherapy |
Radiation: preoperative radiotherapy given 2 weeks post NACT or count recovery at a dose of 26Gy in 5 fractions with or without a boost dose and/or Regional nodal irradiation based on baseline clinical and radiological characteristics
|
| Comparator Agent |
Standard treatment-Post operative radiotherapy |
Radiation: postoperative radiotherapy given 3-4 weeks post Surgery or wound healing at a dose of 26Gy in 5 fractions to the whole breast in case of Breast Conservation Surgery or to the Chest wall in case of Modified Radical Mastectomy with or without a boost dose and/or Regional nodal irradiation based on baseline clinical and radiological characteristics |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
99.00 Year(s) |
| Gender |
Both |
| Details |
1)Eligibility for NACT:
Patients with inoperable breast cancer:
a)Bulky or matted cN2 axillary nodes
b)cN3 nodal disease
c)cT4 tumors(Inflammatory breast cancer if disease can be contained in radiotherapy portal)
In select patients with operable breast cancer:
a)HER2-positive disease and TNBC, if ≥cT2 or ≥cN1
b)Large primary tumor relative to breast size in a patient who desires breast conservation.
c)cN+ disease likely to become cN0 with preoperative systemic therapy.
d)cT1c, cN0, HER2-positive disease and TNBC.
2)Pathological evidence of breast cancer
3)Informed consent for NACT signed by the patient
4)Absence of Distant mets
5)Age ≥18 years at the time of randomisation
6)Performance status ≤ 2
|
|
| ExclusionCriteria |
| Details |
1)Pregnancy or lactation
2)Prior radiotherapy of the affected or contralateral breast
3)Connective tissue disease, including rheumatoid arthritis and thromboangiitis obliterans
4)Cardiac comorbidities: symptomatic coronary heart disease, prior heart attack, heart failure NYHA II or AHA C, pacemaker, and/or implanted defibrillator
5)Other medical conditions that prohibit the neoadjuvant chemotherapy (i.e. psychiatric diseases, non-compliance, etc.)
6)Patients with pure ductal carcinomas in situ.
7)Patients with non-epithelial malignant conditions of the breast viz. Sarcomas, lymphomas, phyllodes tumors
8)Synchronous primary
|
|
|
Method of Generating Random Sequence
|
Permuted block randomization, variable |
|
Method of Concealment
|
On-site computer system |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Pathological complete response |
Post surgical resection(Post BCS or MRM) in both arms. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Local recurrence rate [in affected breast] (LR) |
5 years |
| locoregional recurrence rate (LRR) |
5 years |
| Disease free survival (DFS) |
5 years |
| Disease metastases free survival (DMFS) |
5 years |
| Overall survival (OS) |
5 years |
| Disease specific survival (DSS) |
5 years |
| Assessment of cosmetic results by the physicians |
5 years |
| Measurement of the quality of life (QOL) |
0,6 months and then yearly for 5 years |
| Assessment of arm lymphedema rates |
0,6 months and then yearly for 5 years |
| Assessment of Brachial plexopathy |
Baseline and then yearly for 5 years |
| Assessment of Acute radiation Toxicity |
Pre RT and Post RT |
| R0 resection rate |
Post Surgery |
| Sentinel Lymph node biopsy yield |
Post SLNB |
| Health economics(Out of pocket expenditure) |
Post completion of Radiotherapy |
| Surgeon questionnaire for ease of surgery |
At time of discharge post Surgery |
| Decrease in Ki67 post Neoadjuvant therapy |
Post Surgery |
| Residual Cancer Burden |
Post Surgery |
| Assessment of Radiation Doses to critical structures and Organs at risk. |
Post Radiotherapy |
|
|
Target Sample Size
|
Total Sample Size="152"
Sample Size from India="152"
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 2/ Phase 3 |
|
Date of First Enrollment (India)
|
17/06/2024 |
| 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="5"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| 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
|
With this trial we aim to study whether the addition of Neoadjuvant radiotherapy following neoadjuvant chemotherapy in breast cancer patients improves pathological complete response which translates into better long term outcomes in comparison to adjuvant radiotherapy.This will be a Randomise,parallel assigned, open label 2 arm trial with patients being randomised post Neoadjuvant chemotherapy to either receive Neoadjuvant Radiotherapy followed by Surgery or directly to Surgery followed by Adjuvant chemotherapy with the primary outcome being Pathological complete response.In view of many phase 2 studies done showing that the neoadjuvant RT is feasible and may be more beneficial, a clinical phase 3 study is desirable. A phase 3 RCT answering the question will clarify the proper sequencing of radiotherapy in patients of breast cancer.
|