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CTRI Number  CTRI/2021/02/031320 [Registered on: 16/02/2021] Trial Registered Prospectively
Last Modified On: 03/01/2023
Post Graduate Thesis  No 
Type of Trial  Observational 
Type of Study   Cohort Study 
Study Design  Single Arm Study 
Public Title of Study   A study to look at the effects of combining chemotherapy and radiation treatments in advanced breast cancer 
Scientific Title of Study   Concurrent chemo-radiotherapy with paclitaxel in locally advanced breast cancer: prospective observational data collection 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
nil  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Priya Iyer 
Designation  Associate Professor 
Affiliation  Cancer Institute 
Address  Department of Radiation oncology, Canal Bank road, Gandhinagar, Adyar, Chennai 600020
Department of Radiation oncology, Canal Bank road, Gandhinagar, Adyar, Chennai 600020
Chennai
TAMIL NADU
600020
India 
Phone  09498082772  
Fax    
Email  priyaonc@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Priya Iyer 
Designation  Associate Professor 
Affiliation  Cancer Institute 
Address  Department of Radiation oncology, Canal Bank road, Gandhinagar, Adyar, Chennai
Department of Radiation oncology, Canal Bank road, Gandhinagar, Adyar, Chennai 600020
Chennai
TAMIL NADU
600020
India 
Phone  09498082772  
Fax    
Email  priyaonc@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Priya Iyer 
Designation  Associate Professor 
Affiliation  Cancer Institute 
Address  Department of Radiation oncology, Canal Bank road, Gandhinagar, Adyar, Chennai
Department of Radiation oncology, Canal Bank road, Gandhinagar, Adyar, Chennai 600020
Chennai
TAMIL NADU
600020
India 
Phone  09498082772  
Fax    
Email  priyaonc@gmail.com  
 
Source of Monetary or Material Support  
Cancer Institute 
 
Primary Sponsor  
Name  Cancer Institute 
Address  Canal Bank road, Gandhinagar, Adyar, Chennai 600020 
Type of Sponsor  Research institution and hospital 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Priya Iyer  Cancer Institute  Department of Radiation oncology, Canal Bank road, Gandhinagar, Adyar, Chennai 600020
Chennai
TAMIL NADU 
9498082772

priyaonc@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Cancer Institute  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: C508||Malignant neoplasm of overlappingsites of breast,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  nil  nil 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  65.00 Year(s)
Gender  Female 
Details  1.All female patients with locally advanced carcinoma breast who are planned for CTRT with paclitaxel as neoadjuvant modality of treatment after multi-speciality board discussion.
2.The following stages as per AJCC TNM staging will be considered as LABC (IIIA, IIIB and IIIC). Except patients with T4a tumors (chest wall fixity).
3.Age between 18 to 65 years
4.Karnofsky performance status score ≥70
5.Normal cardiac function with echocardiography showing Ejection Fraction (EF) > 50%
 
 
ExclusionCriteria 
Details  1.Patients with metastatic disease
2.Patients with chest wall fixity of tumor, as they are not considered for surgery after completion of neoadjuvant treatment.
3.Inflammatory breast cancer.
4.Male breast cancer
5.Patients deemed inoperable at presentation due to factors like lymphedema, chest wall fixity or cutaneous nodules extending beyond the confines of the breast.
6.SGOT (AST) > 2.0 x upper limit of normal (ULN) and SGPT (ALT) >2.0 x ULN and Bilirubin >1.5 x ULN
7.Serum creatinine > ULN
8.Patient has received prior radiotherapy to the affected breast
9.Patients with uncontrolled diabetes mellitus, hypertension or ischemic heart disease.
10.Patient is mentally incapacitated or has a significant emotional or psychiatric disorder that, in the opinion of the investigator, precludes study entry.
11.Hypersensitivity to paclitaxel
12.Grade 2 or more peripheral neuropathy
13.Patient not consenting for treatment
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
To assess the pathological response rate with CTRT in LABC  Till completion of surgery 
 
Secondary Outcome  
Outcome  TimePoints 
To assess toxicity of CTRT in LABC
To assess event free survival (EFS) with use of CTRT in LABC.
 
During treatments and at the end of 5 years 
 
Target Sample Size   Total Sample Size="200"
Sample Size from India="200" 
Final Enrollment numbers achieved (Total)= "200"
Final Enrollment numbers achieved (India)="200" 
Phase of Trial   N/A 
Date of First Enrollment (India)   22/02/2021 
Date of Study Completion (India) 15/12/2022 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="4"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  
Not Applicable 
Recruitment Status of Trial (India)  Completed 
Publication Details   Only after completion of the study  
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
Brief Summary  

Introduction

Locally advanced breast cancers (LABC) account for 30-50% of all breast cancer diagnosed in India . LABC have been defined as tumors larger than 5 cm, those associated with bulky/fixed axillary lymph nodes or tumors with skin involvement. (TNM stage III, T3-4 or N2-3).  Treatment of LABC includes a multimodality approach comprising of chemotherapy, surgery and radiation therapy. Majority of the patients with LABC have inoperable disease at diagnosis due to a large tumor mass or axillary nodal fixity and are therefore treated with neoadjuvant chemotherapy (NACT) or concurrent chemoradiotherapy (CTRT) to downsize the tumor to make it operable.  The current standard of care for treating LABC is NACT followed by surgery and sequential radiotherapy. However, few centres in the World including Cancer Institute use neoadjuvant CTRT in addition to NACT for downsizing LABC. Pathological complete response (CR) to neoadjuvant treatment is an important surrogate marker for Overall Survival (OS) in breast cancer especially in triple negative and Her2 positive subset.  Pathological CR rates have over the years increased in LABC with the incorporation of taxanes and anti-Her2 therapy in Her2 positive breast cancer . Studies have shown that neoadjuvant CTRT in LABC improves pathological CR. However, majority of these studies are retrospective in nature and have small number of patients. Literature has also shown that CTRT in LABC is safe and tolerable in majority of the patients. The rationale of using chemotherapy combined with radiation is that chemotherapy will act as a radiosensitizer, thereby, enhancing the effect of radiation and tackling distant micro-metastasis. The common toxicities of CTRT are skin morbidity and neutropenia.  Cancer Institute has been practicing CTRT in LABC for last 5 decades. Over the years the choice of chemotherapy regimens and radiation planning at Cancer Institute has changed. The present study aims to collect data prospectively regarding the use of concurrent CTRT with paclitaxel in LABC at our centre and assess it safety, efficacy and effect on long-term survival outcome. 

Rationale of Study

It is important to collect prospective data on CTRT with paclitaxel in breast cancer at Cancer Institute to assess its efficacy and safety and understand the benefit of the practice to our patients. There is lesser chance of missing important data in prospective study when compared to retrospective study. The data will help in planning future randomized trials with CTRT in breast cancer at Cancer Institute. Publication of CTRT data in the future will require ethical clearance.  

Aim of Study

·       To evaluate the safety, tolerability and efficacy of concurrent chemo-radiotherapy (CTRT) with paclitaxel in locally advanced breast cancer (LABC)

Primary Objective

·       To assess the pathological response rate with CTRT in LABC

Secondary Objective  

·     To assess toxicity of CTRT in LABC

·     To assess event free survival (EFS) with use of CTRT in LABC.

Materials and Methods

Study type/design:  prospective, observational, data collection

Study site:  Cancer Institute (WIA), Chennai

Study enrolment period: 4 years

Follow-up duration: 5 years from date of last enrollment

Expected enrollment:  50 patients/year (Total 200 patients)

Cancer Institute Practice

For the past 60 years, Cancer Institute has been practicing concurrent chemoradiation in breast cancers. The Institute has been a pioneer in introducing CTRT in LABC. LABC in developed countries is much smaller and usually operable in contrast to LABC in India where the majority of the patients present with bulky tumors that are not amenable to upfront surgery and therefore, Cancer Institute started the practice of adding chemotherapy to enhance the effect of radiation, especially in inoperable breast cancers to make it operable during an era where limited chemotherapy agents were available. With the advent of newer chemotherapy agents, the use of concurrent CTRT has come down, but even today we see patients with bulky LABC tumors that do not respond to NACT alone but have responded to treatment with concurrent CTRT with good tolerability. Also, in tumors with skin involvement, CTRT helps to sterilize the skin and ensures negative margins which in turn leads to good pathological response rates, this may translate to better survival and lesser local recurrence rates.

A retrospective review conducted at cancer institute of 100 patients who received neoadjuvant CTRT with taxol in LABC (Stage III) during 2015-2016 has been published in the Indian Journal of Cancer(     Neoadjuvant concurrent chemoradiation in male breast cancer: Experience from a tertiary cancer center. Indian J Cancer. 2019;56(1):37-40.)

. In this study, pCR was observed in 12/22 (54.5%) patients with the triple-negative disease, 10/34 (29.4%) patients with hormone receptor-positive disease and 12/35 (34.2%) patients with Her2 positive disease. The 2-year event-free survival (EFS) and OS for the entire cohort was 88 % and 73.1 % respectively.

We were the first to report the use of neoadjuvant concurrent CTRT in male breast cancer. The study included 31 male patients with LABC. None of the patients showed a pCR in contrast to what has been seen in female patients with LABC.  

Hence we propose to do a prospective observational study inorder to capture data accurately and for better reporting of safety and efficacy.

 
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