FULL DETAILS (Read-only)  -> Click Here to Create PDF for Current Dataset of Trial
CTRI Number  CTRI/2020/06/025863 [Registered on: 15/06/2020] Trial Registered Prospectively
Last Modified On: 26/03/2023
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Radiation Therapy 
Study Design  Other 
Public Title of Study   Can Volumetric modulated arc radiotherapy spare the thyroid gland in the treatment of head and neck cancers 
Scientific Title of Study   Pilot study to evaluate the feasibility of thyroid sparing Volumetric Modulated Arc Radiotherapy in the management of 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 Amit Bahl 
Designation  Additonal professor  
Affiliation  Post graduate institute of medical education and research 
Address  Department of radiotherapy PGIMER chandigarh 160012

Chandigarh
CHANDIGARH
160012
India 
Phone  6283774431  
Fax    
Email  dramitbahl@yahoo.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Amit Bahl 
Designation  Additonal professor  
Affiliation  Post graduate institute of medical education and research 
Address  Department of radiotherapy PGIMER chandigarh 160012

Chandigarh
CHANDIGARH
160012
India 
Phone  6283774431  
Fax    
Email  dramitbahl@yahoo.com  
 
Details of Contact Person
Public Query  
Name  Dr Amit Bahl 
Designation  Additonal professor  
Affiliation  Post graduate institute of medical education and research 
Address  Department of radiotherapy PGIMER chandigarh 160012

Chandigarh
CHANDIGARH
160012
India 
Phone  6283774431  
Fax    
Email  dramitbahl@yahoo.com  
 
Source of Monetary or Material Support  
Department of Radiotherapy PGIMER Chandigarh 
 
Primary Sponsor  
Name  NONE 
Address  NOT APPLICABLE 
Type of Sponsor  Other [NOT APPLICABLE] 
 
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 Venkata Krishna Vamsi Gade   PGIMER , Chandigarh  Department of Radiotherapy and Oncology, Cobalt Block, Nehru Hospital
Chandigarh
CHANDIGARH 		 9790122173

srikarvamsi@yahoo.co.in 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
INSTITUTE ETHICS COMMITTEE PGIMER  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: C01||Malignant neoplasm of base of tongue, (2) ICD-10 Condition: C10||Malignant neoplasm of oropharynx, (3) ICD-10 Condition: C13||Malignant neoplasm of hypopharynx, (4) ICD-10 Condition: C02||Malignant neoplasm of other and unspecified parts of tongue, (5) ICD-10 Condition: C321||Malignant neoplasm of supraglottis,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Radical RT (66-70 Gy) using SIB-VMAT thyroid sparing technique  A dose volume constraint will be given to the thyroid gland where volume of thyroid gland receiving 50 Gy will be less than 75 %  
Comparator Agent  Radical RT (66-70 Gy) using SIB-VMAT without thyroid sparing  SIB VMAT technique would be used to give radical RT. No dose volume constraint for thyroid gland will be given 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  80.00 Year(s)
Gender  Both 
Details  1 Squamous cell carcinoma of the oral cavity,
oropharynx, supraglottic larynx and hypopharynx
2 Locally advanced disease (Stage III , IV)
3 Histological proof of malignancy
4 Patients treated with radical intent 
 
ExclusionCriteria 
Details  1. Patients with Nasopharyngeal malignancies
2. Patients who have thyroid dysfunction or are known to have thyroid dysfunction during baseline investigations
3. Prior radiotherapy, chemotherapy or head and neck surgery
4.Thyroid malignancies or tumours involving the thyroid gland 
 
Method of Generating Random Sequence   Random Number Table 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
1. To study the feasibility of achieving the dose volume constraints to the thyroid gland using Volumetric modulated arc radiotherapy (VMAT) technique.
2. To evaluate the Dose volume histogram(DVH) coverage of Clinical target volume(CTV) and Planning target volume (PTV) nodal volumes with and without thyroid sparing radiotherapy techniques. 		 Study duration is for 2 years with a sample size of 20 patients 
 
Secondary Outcome  
Outcome  TimePoints 
1. To evaluate the thyroid profile at the end of radiotherapy , 6 months and 12 months for the two study arms.
2. To evaluate the progression free survival at last follow up in both the study arms. 		 Last follow up of 1 yr after treatment completion in both arms 
 
Target Sample Size   Total Sample Size="20"
Sample Size from India="20" 
Final Enrollment numbers achieved (Total)= "26"
Final Enrollment numbers achieved (India)="26" 
Phase of Trial   Phase 2 
Date of First Enrollment (India)   17/06/2020 
Date of Study Completion (India) 10/10/2022 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="2"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  		 Not Applicable 
Recruitment Status of Trial (India)  Completed 
Publication Details   NIL 
Individual Participant Data (IPD) Sharing Statement

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

Brief Summary  
    The thyroid gland receives a significant and unintended dose of radiation during the treatment of head and neck malignancies which leads to hypothyroidism. Both clinical and subclinical hypothyroidism is known to occur after head and neck radiotherapy which would add on to the existing morbidity of these patients with malignancy. With newer conformal techniques of radiotherapy like Volumetric Modulated Arc radiotherapy (VMAT) it is possible to precisely deliver radiation to the disease volume while sparing the organs at risk. Recent literature has suggested possible dose volume constraints to the thyroid gland which when achieved may reduce the incidence of hypothyroidism.
     This study will evaluate if effective thyroid sparing can be achieved using Simultaneous Integrated Boost Radiotherapy in head and neck cancers without compromising the coverage of nodal areas. This has the potential to reduce radiation induced Hypothyroidism and its associated co morbidities in head and neck cancer patients.
 
Close