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
|
|
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
|
|
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
|
|
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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