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CTRI Number  CTRI/2021/08/036041 [Registered on: 31/08/2021] Trial Registered Prospectively
Last Modified On: 24/08/2021
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Radiation Therapy 
Study Design  Other 
Public Title of Study   An experimental study comparing the effects of treatment response and severity of difficulty in swallowing in patients with pharynx or larynx cancer treated with two different radiation techniques (D0-IMRT versus standard IMRT). 
Scientific Title of Study   A quasi-experimental study comparing dysphagia optimized intensity modulated radiotherapy (Do-IMRT) versus standard intensity modulated radiotherapy (S-IMRT).  
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Karthik Subramaniam Thiagarajan 
Designation  MDRT Post Graduate 
Affiliation  Sri Ramachandra University 
Address  Department of Radiation Oncology (F0), Sri Ramachandra Institute of Higher Education and Research, Porur, Chennai - 600116

Chennai
TAMIL NADU
600116
India 
Phone  9176611322  
Fax    
Email  karthiksubbu.14@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr K Satish Srinivas  
Designation  Professor and Head of Department 
Affiliation  Sri Ramachandra University 
Address  Department of Radiation Oncology (F0), Sri Ramachandra Institute of Higher Education and Research, Porur, Chennai - 600116

Chennai
TAMIL NADU
600116
India 
Phone  9884780974  
Fax    
Email  dr_satishsrinivas@sriramachandra.edu.in  
 
Details of Contact Person
Public Query
 
Name  Karthik Subramaniam Thiagarajan 
Designation  MDRT Post Graduate 
Affiliation  Sri Ramachandra University 
Address  Department of Radiation Oncology (F0), Sri Ramachandra Institute of Higher Education and Research, Porur, Chennai - 600116

Chennai
TAMIL NADU
600116
India 
Phone  9176611322  
Fax    
Email  karthiksubbu.14@gmail.com  
 
Source of Monetary or Material Support  
Sri Ramachandra Institute of Higher Education and Research, Porur, Chennai - 600116 
 
Primary Sponsor  
Name  Karthik Subramaniam Thiagarajan 
Address  Department of Radiation Oncology (F0), Sri Ramachandra Institute of Higher Education and Research, Porur, Chennai - 600116 
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 
Karthik Subramaniam Thiagarajan  Sri Ramachandra Institute of Higher Education and Research, Porur, Chennai - 600116  Department of Radiation Oncology (F0)
Chennai
TAMIL NADU 
9176611322

karthiksubbu.14@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: C00-D49||Neoplasms,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Dysphagia optimized intensity modulated radiotherapy (Do-IMRT) technique   Contouring DARS (dysphagia and aspiration related structures) as a separate OAR (organ at risk) and reducing the radiation dose to pharyngeal constrictors thereby hoping to lower the severity of dysphagia in these patients post radiation (severity of dysphagia in these patients will be compared to those who received standard intensity modulated radiotherapy) Dose - Hypopharynx primary Inferior Pharyngeal Constrictor - Mean 50Gy Superior/Middle Pharyngeal Constrictor - Mean 40Gy Dose - Oropharynx primary Inferior Pharyngeal Constrictor - Mean 20Gy Superior/Middle Pharyngeal Constrictor - Mean 50Gy Total Dose - 66Gy in 33 fractions Frequency - One fraction per day - Five fractions per week (Monday to Friday) for a total of 33 fractions Total duration - 6.5 weeks treatment  
Comparator Agent  Standard intensity modulated radiotherapy (S-IMRT) technique  Assessing the severity of dysphagia in these patients in whom DARS (dysphagia and aspiration related structures) was not contoured as a separate organ at risk (OAR) as in standard treatment technique - severity of dysphagia in these patients will be compared to those receiving dysphagia optimized intensity modulated radiotherapy Pharyngeal constrictor muscles - Not contoured separately Total Dose - 66Gy in 33 fractions Frequency - One fraction per day - Five fractions per week (Monday to Friday) for a total of 33 fractions Total duration - 6.5 weeks treatment  
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  70.00 Year(s)
Gender  Both 
Details  1) Patients with stage T2-T4, N+, M0 carcinoma of oropharynx, hypopharynx or larynx with squamous cell carcinoma histology only
2) ECOG performance 0-2
3) Written informed consent.
 
 
ExclusionCriteria 
Details  • Patients with head and neck cancer with non-squamous cell carcinoma histology
• Cancer sites other than oropharynx, hypopharynx, or supraglottic larynx
• Patients with T1 N0 M0 (or M1) disease in the above-mentioned sites
• Patients with recurrent cancer in the above-mentioned sites
• Patients not fit for concurrent chemoradiation (or receiving chemotherapy other than weekly cisplatin)
• Documented evidence of pre-existing swallowing dysfunction (not related to cancer)
• Previous radiotherapy to the head and neck region
• ECOG performance 3-4
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Participant Blinded 
Primary Outcome  
Outcome  TimePoints 
Severity of dysphagia  3 months post radiation  
 
Secondary Outcome  
Outcome  TimePoints 
Treatment response  Comparison of pre-treatment PET-CT scan with post-treatment PET-CT scan 
 
Target Sample Size   Total Sample Size="40"
Sample Size from India="40" 
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)   06/09/2021 
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="2"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   NIL 
Individual Participant Data (IPD) Sharing Statement

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

Response - NO
Brief Summary  

Dysphagia following chemoradiation for patients with head and neck cancers have led to a devastating impact on their quality of life, as it leads to a change in the type of diet, prolongation of meal times, or even a need for tube feeding. Although other significant toxicities have been reduced by developments in radiation techniques, dysphagia continues to be a challenge for radiation oncologists. Many phase II studies have shown that reducing the radiation dose to critical swallowing structures such as the pharyngeal constrictor muscle and supraglottic larynx can lead to better outcomes; however, there are limited prospective studies to have verified this benefit. The aim of this study is to compare the effects of standard intensity modulated radiotherapy (S-IMRT) and dysphagia-optimized intensity modulated radiotherapy (Do-IMRT) on severity of dysphagia as well as immediate treatment response in patients undergoing concurrent chemoradiation for oropharyngeal, hypopharyngeal, and supraglottic laryngeal cancer (T2-T4, N+, M0). The swallowing function will be assessed by means of a modified barium swallow technique performed six months after treatment and the treatment response will be assessed by comparing the PET-CT scan taken six months after treatment with the pre-treatment PET-CT scan.

 
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