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CTRI Number  CTRI/2021/04/032672 [Registered on: 08/04/2021] Trial Registered Prospectively
Last Modified On: 04/06/2022
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Radiation Therapy 
Study Design  Single Arm Study 
Public Title of Study   Assessment of treatment outcome of Hypofractionated Radiotherapy using modern age radiotherapy technique with concurrent chemotherapy in Locally advanced cancers of Larynx and Hypopharynx  
Scientific Title of Study   Prospective Study on Hypofractionated Intensity Modulated Radiation Therapy(using VMAT Technique) with Concurrent Chemotherapy in Locally Advanced Laryngeal and Hypopharyngeal Squamous Cell Cancers 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Rupak Sett 
Designation  DNB Post Graduate Trainee 
Affiliation  Chittaranjan National Cancer Institute 
Address  Room No-23, Department of Radiotherapy, Ground floor, Chittaranjan National Cancer Institute 37,S.P Mukherjee Road, Kolkata
Room No-23, Department of Radiotherapy, Ground floor, Chittaranjan National Cancer Institute37,S.P Mukherjee Road, Kolkata
Kolkata
WEST BENGAL
700026
India 
Phone  9433138876  
Fax    
Email  settrupak1@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Debarshi Lahiri 
Designation  Specialist, Dept of Radiotherapy, CNCI 
Affiliation  Chittaranjan National Cancer Institute 
Address  Room No-25, Department of Radiotherapy,Ground Floor, Chittaranjan National Cancer Institute, 37,S.P Mukherjee Road, Kolkata
Room No-25, Department of Radiotherapy,Ground Floor, Chittaranjan National Cancer Institute, 37,S.P Mukherjee Road, Kolkata
Kolkata
WEST BENGAL
700026
India 
Phone  9051513564  
Fax    
Email  debarshil@gmail.com  
 
Details of Contact Person
Public Query  
Name  Rupak Sett 
Designation  DNB Post Graduate Trainee 
Affiliation  Chittaranjan National Cancer Institute 
Address  Room No 23, Department of Radiotherapy, Ground Floor,Chittaranjan National Cancer Institute, 37,S.P Mukherjee Road, Kolkata
Room No 23, Department of Radiotherapy, Ground Floor,Chittaranjan National Cancer Institute,37,S.P Mukherjee Road, Kolkata
Kolkata
WEST BENGAL
700026
India 
Phone  9433138876  
Fax    
Email  settrupak1@gmail.com  
 
Source of Monetary or Material Support  
Chittaranjan National Cancer Institute. 37, S.P Mukherjee Road, Kolkata-700026 
 
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 
Rupak Sett  Chittaranjan National Cancer Institute  Room No 23, Department of Radiotherapy, Ground Floor, 37,S.P Mukherjee Road, Kolkata-700026
Kolkata
WEST BENGAL 		 9433138876

settrupak1@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: C329||Malignant neoplasm of larynx, unspecified,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Hypofractionated Intensity Modulated Radiation Therapy (using VMAT Technique) with Concurrent Chemotherapy  Patients will receive concurrent chemo-radiation with 2 cycles of 3-weekly Cisplatin 100 mg/m2 on day 1 and day 22 along with hypofractionated intensity modulated radiation therapy (IMRT by VMAT technique) 55 Gy/20 fractions in PTV 55, 50 Gy/20 fractions in PTV 50 and 46 Gy/20 fractions in PTV 46 to be delivered over 4 weeks.  
 
Inclusion Criteria  
Age From  20.00 Year(s)
Age To  65.00 Year(s)
Gender  Both 
Details  Locally advanced, non-metastatic histopathology or cytology-proven, squamous cell carcinoma of Hypopharynx and Larynx (T3/T4a N0/N1/N2 M0) sent from multidisciplinary tumour board for CCRT.
Age 20 years to 65 years.
Eastern Cooperative Oncology Group (ECOG) performance status up to 2.
Haemoglobin ≥10 gm%, white blood cell count ≥4000/mm3, platelet count ≥1 lakh/mm3 (initially or after correction by blood transfusion).
Liver function test and kidney function test, both within normal limit.
Baseline audiometry limited to mild sensory neural deficits.
 
 
ExclusionCriteria 
Details  Disease previously treated by radiotherapy, chemotherapy or surgery (other than biopsy and tracheostomy).
Age <20 years or >65 years.
Patients having significant medical co-morbidities.
Pregnancy or lactation.
Evidence of distant metastasis.
Patients unwilling to participate in the study or who do not give consent.

 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Evaluation of loco-regional response.
Assessment of toxicity (Acute and Late).
 		 Evaluation of loco-regional response will be assessed at 3 months after completion of treatment.
Assessment of toxicity (Acute and Late) during treatment and at 2 weeks, 4 weeks, 6 weeks, 3 months & 6 months after treatment.
 
 
Secondary Outcome  
Outcome  TimePoints 
Assessment of disease-free survival.
 		 2 years 
 
Target Sample Size   Total Sample Size="44"
Sample Size from India="44" 
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)   12/04/2021 
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)
Modification(s)  		 Not Applicable 
Recruitment Status of Trial (India)  Closed to Recruitment of Participants 
Publication Details    
Individual Participant Data (IPD) Sharing Statement

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

Response - NO
Brief Summary
Modification(s)  		 Radiotherapy, in combination with chemotherapy is the mainstay of treatment for locally advanced laryngeal and hypopharyngeal cancers, as radical surgery is associated with high morbidity and functional compromise. The development of Intensity Modulated Radiation Therapy (IMRT) has resulted in improved dose distributions, with smaller volumes of normal tissues receiving high doses; which provides the opportunity of increasing the dose per fraction. Volumetric modulated arc therapy (VMAT) is a novel technique of delivering IMRT that reduces treatment delivery time and offers good conformity. Chemotherapy induced radio sensitization can also be considered as a method of biologic dose escalation. In this study, 44 patients will be selected based on their stage, general condition, other inclusion and exclusion criteria. The selected patients will be simulated by CT simulator. After CT simulation, contouring of the tumor and critical structures will be done. Patient will receive 55 Gy/20# to PTV 55, 50 Gy/20# to PTV 50 and 46 Gy/20# to PTV 46. Along with this, they will receive concurrent chemotherapy with injection cisplatin. First 3 follow-up visits will be at 2 weeks, 4 weeks and 6 weeks after completion of treatment. Thereafter, the follow up to continue monthly once for the first 6 months and at 3 monthly intervals for the rest of the study period. In each follow-up, patient will undergo a complete head and neck examination and will be assessed clinically for response and toxicities. Investigations will be done accordingly. CECT neck will be done 3 months post treatment to assess the tumor response and will be correlated clinically. Response will be assessed using RECIST version 1.1. Acute and late toxicities will be assessed and graded as per CTCAE version 5.0.
In this study, 44 patients recruited till closure of recruitment and planned hypofractionated IMRT using VMAT technique (55 Gy in 20#) plus 3 weekly Cisplatin 100 mg/sqm. Among them, 43 patients (97.7%) received full course of treatment and 1 patient (2.3%) did not complete (discontinued after 2# radiotherapy) the treatment.
 
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