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CTRI Number  CTRI/2021/09/036821 [Registered on: 24/09/2021] Trial Registered Prospectively
Last Modified On: 08/01/2023
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Radiation Therapy 
Study Design  Single Arm Study 
Public Title of Study   Phase II Open Label Study to Investigate Impact of Adaptive Radiotherapy on Quality of Life Score in Patients with Locally Advanced Head and Neck Cancers 
Scientific Title of Study   Phase II Open Label Study to Investigate Impact of Adaptive Radiotherapy on Quality of Life Score in Patients with Locally Advanced Head and Neck Cancers 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Atokali Chophy 
Designation  Junior Resident 
Affiliation  AIIMS Rishikesh 
Address  Department of Radiation Oncology AIIMS Rishikesh

Dehradun
UTTARANCHAL
249203
India 
Phone  8974638900  
Fax    
Email  chophy.atokali21@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Sweety Gupta 
Designation  Associate Professor 
Affiliation  AIIMS Rishikesh 
Address  Department of Radiation Oncology AIIMS Rishikesh

Dehradun
UTTARANCHAL
249203
India 
Phone  9891981332  
Fax    
Email  drsg2411@yahoo.co.in  
 
Details of Contact Person
Public Query  
Name  Dr Sweety Gupta 
Designation  Associate Professor 
Affiliation  AIIMS Rishikesh 
Address  Department of Radiation Oncology AIIMS Rishikesh

Dehradun
UTTARANCHAL
249203
India 
Phone  9891981332  
Fax    
Email  drsg2411@yahoo.co.in  
 
Source of Monetary or Material Support  
Department of Radiation Oncology AIIMS Rishikesh 
 
Primary Sponsor  
Name  None 
Address  NA 
Type of Sponsor  Other [] 
 
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 Atokali Chophy  Department of Radiation Oncology  AIIMS Rishikesh, Virbhadra road , Rishikesh Dehradun
Dehradun
UTTARANCHAL 		 8974638900

chophy.atokali21@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee AIIMS Rishikesh  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: C00-C14||Malignant neoplasms of lip, oral cavity and pharynx,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Mid treatment replanning  Patients on IMRT/Chemo-IMRT are rescanned after 20th fraction and replanned and new plan is executed at 22nd fraction 
Comparator Agent  Not applicable   Not applicable  
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  70.00 Year(s)
Gender  Both 
Details  1. Patients with histologically proven Squamous Cell Carcinoma of head and neck region
2. Age <70 years
3. Primary tumour sites in oral cavity, oropharynx, hypopharynx and larynx.
4.Stage III-IVB by AJCC Cancer Staging Manual Eight Edition, 2018
5.Eastern Cooperative Oncology Group (ECOG) performance status ≤2
6.All patients fit for chemo-radiation/Radiation Therapy

 
 
ExclusionCriteria 
Details  1. Patients with resection of the primary tumour or recurrent disease
2. Patients with distant metastasis
3. Patients who have received prior NACT or surgery
4. Patients who have received prior radiation therapy.
 
 
Method of Generating Random Sequence    
Method of Concealment    
Blinding/Masking    
Primary Outcome  
Outcome  TimePoints 
To assess the quality of life in Locally advanced Head and Neck cancer patients undergoing IMRT/Chemo-IMRT with mid treatment adaptive replanning  6 months 
 
Secondary Outcome  
Outcome  TimePoints 
1. To asses acute toxicity during 6 weeks in patients of Locally advanced Head and Neck cancers undergoing IMRT with mid treatment adaptive replanning
2. To assess the incidence of xerostomia at 6 months in patients of Locally advanced Head and Neck cancers undergoing IMRT with mid treatment adaptive replanning
 		 6 months 
 
Target Sample Size   Total Sample Size="34"
Sample Size from India="34" 
Final Enrollment numbers achieved (Total)= "34"
Final Enrollment numbers achieved (India)="34" 
Phase of Trial   Phase 2 
Date of First Enrollment (India)   28/09/2021 
Date of Study Completion (India) 30/11/2022 
Date of First Enrollment (Global)  28/09/2021 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="1"
Months="7"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  		 Completed 
Recruitment Status of Trial (India)  Completed 
Publication Details   none 
Individual Participant Data (IPD) Sharing Statement

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

Response - NO
Brief Summary   Head and neck carcinoma is one of the most common cancers with a global incidence of 6,57,438 and mortality of 3,36,360 in 2018, accounting for 3.6% of all cancer cases and 3.6% of all cancer cases. In India, Head and Neck cancers account for 30% of all cancers. The standard radiotherapy techniques for the treatment of head and neck squamous cell carcinomas (HNSCC) are highly conformal, modulated techniques such as helical IMRT (Tomotherapy), volumetric modulated arc therapy (VMAT) and intensity modulated radiation therapy (IMRT). 

Many patients during the course of radiation treatment develop significant anatomic changes, hence doses to target volumes and normal structures during the course may differ significantly compared to the initial computed tomography (CT) images obtained before the treatment-which is the base of planning of treatment. 
 By 2nd week of radiotherapy during a course of chemoradiotherapy most significant volumetric changes and dosimetric alterations in the tumour volumes and organs at risk occur. IMRT plans based on a single planning CT dataset may lead to unexpected complications and/or to marginal geographic misses of target volumes. 
A possible strategy to overcome these limitations is Adaptive radiotherapy (ART). ART is a novel approach which uses repeat imaging and re-planning to adapt to actual patient anatomy. 
Published data on adaptive radiotherapy is limited in India due to technical and logistic challenges.
 Literature have shown that Adaptive Radiotherapy reduces the dose to the OARs and thus reduces the toxicity.  As IMRT improves QoL by reducing doses to OARs & adaptive replanning has shown to further improve, we hypothesize that adaptive radiotherapy will improve QoL in Locally advanced head and neck cancers over and above to that with IMRT alone in locally advanced H&N cancers. 
 
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