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CTRI Number  CTRI/2025/09/094928 [Registered on: 16/09/2025] Trial Registered Prospectively
Last Modified On: 16/09/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Radiation Therapy 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Comparative Study Between Two Types of Courses of Thoracic Radiotherapy in Stage IV Lung Cancer 
Scientific Title of Study   A Comparative Study Between Two Thoracic Radiotherapy Schedules for Palliation of Symptoms, Radiological Responses and Acute Toxicities in Stage IV Non-Small Cell Lung Cancer 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Sharad Sah 
Designation  First Year Post Graduate Resident  
Affiliation  IPGMER and SSKM Hospital, Kolkata 
Address  Department of Radiation Oncology, IPGMER and SSKM Hospital, 244, A.J.C. Bose Road, Kolkata

Kolkata
WEST BENGAL
700020
India 
Phone  9999336405  
Fax    
Email  sharad.sah98@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Suranjan Maitra 
Designation  Assistant Professor  
Affiliation  IPGMER and SSKM Hospital, Kolkata 
Address  Department of Radiation Oncology, IPGMER and SSKM Hospital, 244, A.J.C. Bose Road, Kolkata

Kolkata
WEST BENGAL
700020
India 
Phone  9933099901  
Fax    
Email  suranjanmaitra9@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Suranjan Maitra 
Designation  Assistant Professor  
Affiliation  IPGMER and SSKM Hospital, Kolkata 
Address  Department of Radiation Oncology, IPGMER and SSKM Hospital, 244, A.J.C. Bose Road, Kolkata

Kolkata
WEST BENGAL
700020
India 
Phone  9933099901  
Fax    
Email  suranjanmaitra9@gmail.com  
 
Source of Monetary or Material Support  
Department of Radiotherapy, IPGME&R and SSKM Hospital, 244, AJC Bose Road Kolkata, West Bengal, India, PIN code- 700020 
 
Primary Sponsor  
Name  Dr Sharad Sah 
Address  Department of Radiotherapy, IPGME&R and SSKM Hospital, 244, AJC Bose Road, Kolkata, 700020 
Type of Sponsor  Other [Self] 
 
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 
Dr Sharad Sah  IPGME&R and SSKM Hospital   Room No. 4, Department of Radiotherapy, IPGMER and SSKM Hospital, 244, A.J.C. Bose Road, Kolkata
Kolkata
WEST BENGAL 
9999336405

sharad.sah98@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
IPGME&R Research Oversight Committee   Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: C34||Malignant neoplasm of bronchus andlung,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  17 Gy in 2 fractions, one week apart  Comparison between two palliative thoracic radiotherapy regimens in stage IV Non Small Cell Lung Cancer. 
Intervention  20 Gy in 5 consecutive days  Comparison between two palliative thoracic radiotherapy regimens in stage IV Non Small Cell Lung Cancer. 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  70.00 Year(s)
Gender  Both 
Details  1. Histologically or Cytologically proven Non-Small Cell Lung Cancer
2. Stage IV Lung Cancer, according to AJCC Staging 9th version
3. Age more than 18 years and less than 70 years
4. Any Sex
5. ECOG Grade 0-3
6. Patients willing to take part in the study with an informed written consent. 
 
ExclusionCriteria 
Details  1. Small Cell Lung Cancer
2. Patients with collagen vascular disease or any other systemic comorbidities or severe uncontrolled infection, which may alter treatment outcome.
3. Pregnant or Nursing Women
4. Patients who had deranged blood parameters, impaired liver function, renal function and bone marrow suppression.
5. Patients refusing to take part in the study. 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   An Open list of random numbers 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
To compare between two radiotherapy regimens p 20 Gy/5# in 5 consecutive days and 17 Gy/2# over a week apart and fine the more effective one in terms of:
1. Symptom relief
2. To check acute toxicities using RTOG scale, and manage patients, if necessary
3. To evaluate the variation in symptomatic relief associated with different presenting symptoms when administering two distinct radiotherapy regimens, using LCSS scale/RTOG 4 point scale 
18 months 
 
Secondary Outcome  
Outcome  TimePoints 
NIL  18 months 
 
Target Sample Size   Total Sample Size="60"
Sample Size from India="60" 
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)   29/09/2025 
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="1"
Months="6"
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  

              Despite numerous research articles published over the years to determine the most effective radiotherapy regimen for Stage IV non-small cell lung cancer (NSCLC), particularly for acute palliative care, a definitive consensus remains elusive. Both extended and short fraction regimens have been thoroughly investigated, yet the choice of regimen often hinges on institutional protocols, the preferences of the treating physician, and, most importantly, the general condition of the patient. Various countries and treatment centres may opt for different regimens based on resource availability, patient volume, and clinical experience. It has been observed that while long-duration regimens may offer better overall survival for patients in good condition, hypo-fractionated regimens provide comparable efficacy in symptom control with fewer treatment sessions. However, longer regimens may increase the risk of toxicity and adverse effects on critical structures. This ongoing uncertainty underscores the need for further research tailored to specific clinical settings.


 
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