| 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
|
|
|
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
|
|
|
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.
|