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CTRI Number  CTRI/2021/09/036417 [Registered on: 10/09/2021] Trial Registered Prospectively
Last Modified On: 31/03/2023
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Follow Up Study 
Study Design  Single Arm Study 
Public Title of Study   To study the clinical variations and dose volume changes with adaptive radiotherapy in head and neck cancers 
Scientific Title of Study   A prospective study to evaluate the clinical outcomes and dose volume histogram (DVH) parameters of adaptive intensity modulated radiotherapy in the treatment of patients with 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 SRAVANTHI BUDITHI 
Designation  Junior resident 
Affiliation  Sri venkateswara institute of medical sciences 
Address  department of radiation oncology, SVIMS cancer center, tirupati
Department of radiation oncology, SVIMS cancer center, Tirupati
Chittoor
ANDHRA PRADESH
535546
India 
Phone  9618083516  
Fax    
Email  sravanthibudithi8@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Pranabandhu Das 
Designation  Associate professor 
Affiliation  Sri venkateswara institute of medical sciences 
Address  department of radiation oncology, SVIMS cancer center, Tiruapti

Chittoor
ANDHRA PRADESH
517501
India 
Phone  9493547731  
Fax    
Email  daspranabandhu@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Pranabandhu Das 
Designation  Associate professor 
Affiliation  Sri venkateswara institute of medical sciences 
Address  department of radiation oncology, SVIMS cancer center, Tiruapti

West Godavari
ANDHRA PRADESH
517501
India 
Phone  9493547731  
Fax    
Email  daspranabandhu@gmail.com  
 
Source of Monetary or Material Support  
Sri venkateswara institute of medical sciences, Tirupati 
 
Primary Sponsor  
Name  svims tirupati 
Address  department of radiation oncology, svims cancer center, tirupati 
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 
Dr sravanthi budithi  sri venkateswara institute of medical sciences   department of radiation oncology, svims cancer center, tirupati
Chittoor
ANDHRA PRADESH 
9618083516

sravanthibudithi8@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
institution ethics committee  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 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  65.00 Year(s)
Gender  Both 
Details  1. histopathologically proven squamous cell carcinoma of head and neck
2.cancers of oralcavity, oropharynx, hypopharynx and larynx
3. stage 3 to stage 4b disease
4. patients with ECOG performance status 0 to 2
5. patients who has given approved informed consent 
 
ExclusionCriteria 
Details  1. patients previously treated with surgery, chemotherapy or radiotherapy
2. patients with distant metastasis
3.patients with ECOG performance status 3 and 4
4.pregnant women and lactating mothers 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
AIM
To evaluate clinical outcome variations and dose volumetric changes with adaptive IMRT in head and neck cancers

objectives
to document and assess following parameters
1. acute toxicities
a) mucositis
b) dermatitis
c) dysphagia
d) voice changes
e) xerostomia
2. clinical responce rate
a) changes in gross tumor volume (GTV)
b) changes in nodal volume
3. Dose volumetric parameters
a) dose to parotid gland
b) dose to spinal cord 
all the patients will undergo CT simulation and treatment planning by IMRT
patients will be assessed baseline and weekly basis during RT for acute toxicities
patients will undergo rescan and replanning around 23fractions (3 to 5 weeks) and dose volume changes are compared with inital scan 
 
Secondary Outcome     
Target Sample Size   Total Sample Size="64"
Sample Size from India="64" 
Final Enrollment numbers achieved (Total)= "64"
Final Enrollment numbers achieved (India)="64" 
Phase of Trial   N/A 
Date of First Enrollment (India)   15/09/2021 
Date of Study Completion (India) 21/12/2022 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="1"
Months="5"
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)?  

Response - NO
Brief Summary
Modification(s)  
AIM OF THE STUDY : To evaluate clinical outcome variations and dose volumetric changes with adaptive rt in head and neck cancers 

OBJECTIVES : To document and assess the following parameters
1. Acute toxicites : mucositis, dermatitis, dysphagia, voice changes, and xerostomia
2. Clinical response rate : changes in gross tumor volume and changes in nodal volume
3.dose volumetric parameters : dose to parotid gland and dose to spinal cord 

all patients will undergo CT simulation and treatment planning by IMRT initially, and will be reviewed weekly basis while RT is going on for grading acute toxicities. 

During the course of treatment patient will undergo rescan and replanning around 23 fractions and dose volume changes are compared with initial scan for gross tumor volume, nodal volume, dose to parotid gland and dose to spinal cord 

During the time period between March 2021 to December 2022, after histopathological confirmation 64 patients were recruited into the study after screening and excluding the patients based on exclusion criteria. Pre-treatment evaluation done in all patients before starting RT. Planning CT was taken with Siemens AS 20 CT simulator and the images were transferred to the MONACO treatment planning systems. All the patients were treated with Elekta synergy linear accelerator (Elekta, Stockholm) with IMRT. In 64 patients, 43 patients received 66Gy and 21 patients received 70Gy. After 22# all patients underwent re CT simulation and replanning

·       The Mean GTV-P volume is 59.03cc in Initial plan and 41.24cc in the Replan with a mean reduction of 30.4%.

·       Mean GTV-N is 48.98cc in initial plan and 31.09cc in Replan with mean reduction of 36.2%.

·       We achieved reduced volume of tumour was calculated to be at the rate of 1.11% per day.

·       The mean reduction in the Dmax Spinal Cord dose, Dmean Right Parotid and Dmean Left Parotid 3.4%, 6.3% and 4.5% respectively. The Above values were found to be statistically significant

·       V95% is more than 95% and v107% is less than 2% in both initial and replans.

The observed acute radiation induced toxicities in our studies were mucositis, dermatitis, dysphagia, xerostomia and voice changes. Most of the patients had grade 2 and grade 3 acute toxicities. Maximal grading in acute toxicities; Mucositis is Grade 2-38/64 (59.37%), Dermatitis is Grade 2-46/64 (71.87%), Dysphagia is Grade 2-37/64 (57.8%), Voice changes is grade 2-29/64 (57.8%), Xerostomia Grade 1 is 50/64 (78.1%). No one experienced grade 3, grade 4 xerostomia. There were no deaths during the course of treatment.

All 64 patients underwent response evaluation in 8-10weeks after the completion of treatment. In those 56.25% patients had complete response, 32.81% patients had partial response, 7.81% patients had progressive disease and 3.12% patients had stable disease.




 
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