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CTRI Number  CTRI/2021/05/033625 [Registered on: 17/05/2021] Trial Registered Prospectively
Last Modified On: 18/05/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Radiation Therapy 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Comparison between two different schedules of radiotherapy by modern radiotherapy technique in terms of side effects and quality of life in breast cancer patients 
Scientific Title of Study   A prospective comparative study between conventional fractionated radiotherapy and hypofractionated radiotherapy by using 3D-CRT technique with respect to toxicity and quality of life in postmastectomy breast carcinoma. 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Raka Banerjee 
Designation  DNB trainee 
Affiliation  Chittaranjan national cancer institute 
Address  CHITTARANJAN NATIONAL CANCER INSTITUTE, ROOM NUMBER-25, GROUND FLOOR, DEPARTMENT OF RADIOTHERAPY, 37-S.P.MUKHERJEE ROAD,KOLKATA-700026 WEST BENGAL India

Kolkata
WEST BENGAL
700026
India 
Phone  8777704569  
Fax    
Email  introraka218@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Tapas Maji 
Designation  Head of the department of Radiotherapy, Chittaranjan national cancer institute 
Affiliation  Chittaranjan national cancer institute 
Address  CHITTARANJAN NATIONAL CANCER INSTITUTE, ROOM NUMBER-17, GROUND FLOOR, DEPARTMENT OF RADIOTHERAPY, 37-S.P.MUKHERJEE ROAD,KOLKATA-700026 WEST BENGAL India

Kolkata
WEST BENGAL
700026
India 
Phone  9432244844  
Fax    
Email  tapasmaji60@gmail.com  
 
Details of Contact Person
Public Query  
Name  Raka Banerjee 
Designation  DNB trainee 
Affiliation  Chittaranjan national cancer institute 
Address  CHITTARANJAN NATIONAL CANCER INSTITUTE, ROOM NUMBER-25, GROUND FLOOR, DEPARTMENT OF RADIOTHERAPY, 37-S.P.MUKHERJEE ROAD,KOLKATA-700026 WEST BENGAL India

Kolkata
WEST BENGAL
700026
India 
Phone  8777704569  
Fax    
Email  introraka218@gmail.com  
 
Source of Monetary or Material Support  
Chittaranjan National Cancer Institute 
 
Primary Sponsor  
Name  Chittaranjan National Cancer Institute 
Address  37-S.P.MUKHERJEE ROAD,KOLKATA-700026 
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 
Raka Banerjee  CHITTARANJAN NATIONAL CANCER INSTITUTE  ROOM NUMBER-25, GROUND FLOOR, DEPARTMENT OF RADIOTHERAPY, 37-S.P.MUKHERJEE R OAD,KOLKATA-700026 WEST BENGAL
Kolkata
WEST BENGAL 		 8777704569

introraka218@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional ethics committee, Chittaranjan national cancer institute  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
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  comparison between 2 fractionation schedules of radiotherapy in two arms i.e. conventional fractionated radiotherapy and hypofractionated radiotherapy   To assess local toxicity and quality of life between two arms. In conventional fractionated radiotherapy arm patients will receive radiotherapy dose of 50 Gy in 25 fractions (2 Gy per fraction) over 5 weeks (5 days in a week) and in hypofractionated radiotherapy arm patients will receive radiotherapy dose of 40 Gy in 15 fractions (2.67 Gy per fraction) over 3 weeks (5 days in a week) by 3D-CRT technique of external beam radiotherapy. 
Comparator Agent  comparison to assess local toxicity and quality of life between 2 fractionation schedules of radiotherapy in two arms i.e. conventional fractionated radiotherapy and hypofractionated radiotherapy   To assess local toxicity and quality of life between two arms. Patients will be examined for acute toxicities weekly during the course of treatment,at the completion of radiotherapy ,thereby monthly upto 3months,then 3 monthly for2 years,thereafter 6monthlyfor the study duration.Upto 3months patients will be assessed for acute toxicities as graded by RTOG/EORTC Acute Radiation Morbidity criteria,thereafter late toxicities if any will be assessed and recorded by RTOG/EORTC Late Radiation Morbidity Criteria.Quality of life questionnaire will be assessed and compared between the two arms at the initiation of therapy,at completion and thereafter at 3 months and 6 months from the start of radiotherapy. 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  70.00 Year(s)
Gender  Female 
Details  1.Age greater than equal to 18years and less than 70years.
2.Female breast cancer patients.
3.Histopathologically proven Infiltrating Ductal and Infiltrating Lobular carcinoma of the
breast.
4.Patients who will undergo Modified Radical Mastectomy with adequate Axillary
Dissection in our institution and will be indicated for post mastectomy chest wall
radiotherapy.
5.Breast carcinoma patients with documented ER,PR and Her2neu status.
6.No other primary malignancy in any other parts of the body.
7.No history of previous any chest wall irradiation.
8.Eastern Cooperative Oncology Group(ECOG) Performance status 0-2.
9.Patients without any serious co-morbidities like IHD,CVA,Coagulation and Bleeding
disorders.
10.Patients with normal haematological findings of Hb greater than 10gm/dl,TLC greater than 4000/cumm and
Platelet Count of greater than 1lacs/cumm.
12.Patients with normal Kidney and Liver Function Test.
13.Patients with normal Pulmonary Function Test.
14.Patients who will give consent to participate in the study. 
 
ExclusionCriteria 
Details  1.Age<18 years and >70years.
2.Male breast cancer patients.
3.Patients with a histopathological finding other than Invasive Lobular and Ductal
Carcinoma.
4.Breast carcinoma patients withdistant metastasis.
5.Patients with inoperable,clinically fixed,and matted lymph nodes.
6.Patients with inadequate or no axillary dissection.
7.Patients with any other primary malignant tumour.
8.Patients with any chronic dermatological or connective tissue disorders that may interfere
with radiation induced acute skin toxicity assessment.
9.History of any previous chest wall irradiation.
10.Patients with Eastern Cooperative Oncology Group(ECOG)Performance Score>2.
11.Patients with serious active comorbidities like:
History of unstable angina and/or congestive heart failure requiring hospitalization in the
last 6months.
History of myocardial infarction within the last 6months.
Acute or chronic bacterial or fungal infection requiring intravenous antibiotics at the
time of patient registration.
Chronic Obstructive Pulmonary Disease with abnormal Pulmonary Function Test.
Clinical jaundice and bleeding disorders
12.Patients with deranged Liver and Kidney function test results
13.Patients who are HBsAg,Anti HCV antibody and HIV reactive. 
 
Method of Generating Random Sequence   Random Number Table 
Method of Concealment   An Open list of random numbers 
Blinding/Masking   Participant Blinded 
Primary Outcome  
Outcome  TimePoints 
1. To compare acute toxicities between hypofractionated radiotherapy and conventional
radiotherapy to chest wall in Post mastectomy breast cancer patients using 3D-CRT
technique.
2. To compare Quality of Life of the patients treated by the regimens of either of the above
two arms. 		 Upto 3 months for acute toxicities and upto 9 months for quality of life assessment 
 
Secondary Outcome  
Outcome  TimePoints 
To compare late toxicities between hypofractionated radiotherapy and conventional
radiotherapy to chest wall in Post mastectomy breast cancer patients using 3D-CRT
technique 		 3 years 
 
Target Sample Size   Total Sample Size="52"
Sample Size from India="52" 
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="52" 
Phase of Trial   Phase 2/ Phase 3 
Date of First Enrollment (India)   21/05/2021 
Date of Study Completion (India) 07/05/2024 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="3"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  		 Not Applicable 
Recruitment Status of Trial (India)  Completed 
Publication Details   Nil 
Individual Participant Data (IPD) Sharing Statement

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

Response - YES
  1. What data in particular will be shared?
    Response - All of the individual participant data collected during the trial, after de-identification.

  2. What additional supporting information will be shared?
    Response -  Study Protocol
    Response -  Statistical Analysis Plan
    Response - Informed Consent Form

  3. Who will be able to view these files?
    Response - Researchers whose proposed use of the data has been approved by an independent review committee identified for this purpose.

  4. For what types of analyses will this data be available?
    Response - To achieve aims in the approved proposal.

  5. By what mechanism will data be made available?
    Response - Proposals should be directed to [introraka218@gmail.com].

  6. For how long will this data be available start date provided 18-05-2024 and end date provided 18-05-2029?
    Response - Beginning 3 months and ending 5 years following article publication.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - NIL
Brief Summary
Modification(s)  		 At a median follow up duration of 9 months for each patients enrolled in the study, there was no statistically significant difference in either acute toxicities or quality of life between the two arms of the study at any point of follow up. At last follow-up there was no incidence of locoregional failure in any patient of either arms. Hypofractionated chest wall radiotherapy was well tolerated with acceptable toxicities and better compliance with no event of treatment interruptions due to side effects or toxicities warranting hospitalizations.  This study thus established the non-inferiority of hypofractionated radiotherapy to conventionally fractionated radiotherapy in postmastectomy breast cancer patients with reduced burden on health care resources and improved patient compliance. 
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