| CTRI Number |
CTRI/2021/08/036041 [Registered on: 31/08/2021] Trial Registered Prospectively |
| Last Modified On: |
24/08/2021 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Radiation Therapy |
| Study Design |
Other |
|
Public Title of Study
|
An experimental study comparing the effects of treatment response and severity of difficulty in swallowing in patients with pharynx or larynx cancer treated with two different radiation techniques (D0-IMRT versus standard IMRT). |
|
Scientific Title of Study
|
A quasi-experimental study comparing dysphagia optimized intensity modulated radiotherapy (Do-IMRT) versus standard intensity modulated radiotherapy (S-IMRT). |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Karthik Subramaniam Thiagarajan |
| Designation |
MDRT Post Graduate |
| Affiliation |
Sri Ramachandra University |
| Address |
Department of Radiation Oncology (F0), Sri Ramachandra Institute of Higher Education and Research, Porur, Chennai - 600116
Chennai TAMIL NADU 600116 India |
| Phone |
9176611322 |
| Fax |
|
| Email |
karthiksubbu.14@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Dr K Satish Srinivas |
| Designation |
Professor and Head of Department |
| Affiliation |
Sri Ramachandra University |
| Address |
Department of Radiation Oncology (F0), Sri Ramachandra Institute of Higher Education and Research, Porur, Chennai - 600116
Chennai TAMIL NADU 600116 India |
| Phone |
9884780974 |
| Fax |
|
| Email |
dr_satishsrinivas@sriramachandra.edu.in |
|
Details of Contact Person Public Query
|
| Name |
Karthik Subramaniam Thiagarajan |
| Designation |
MDRT Post Graduate |
| Affiliation |
Sri Ramachandra University |
| Address |
Department of Radiation Oncology (F0), Sri Ramachandra Institute of Higher Education and Research, Porur, Chennai - 600116
Chennai TAMIL NADU 600116 India |
| Phone |
9176611322 |
| Fax |
|
| Email |
karthiksubbu.14@gmail.com |
|
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Source of Monetary or Material Support
|
| Sri Ramachandra Institute of Higher Education and Research, Porur, Chennai - 600116 |
|
|
Primary Sponsor
|
| Name |
Karthik Subramaniam Thiagarajan |
| Address |
Department of Radiation Oncology (F0), Sri Ramachandra Institute of Higher Education and Research, Porur, Chennai - 600116 |
| Type of Sponsor |
Other [Self] |
|
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Details of Secondary Sponsor
|
|
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Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Karthik Subramaniam Thiagarajan |
Sri Ramachandra Institute of Higher Education and Research, Porur, Chennai - 600116 |
Department of Radiation Oncology (F0) Chennai TAMIL NADU |
9176611322
karthiksubbu.14@gmail.com |
|
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Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee |
Approved |
|
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Regulatory Clearance Status from DCGI
|
|
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Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: C00-D49||Neoplasms, |
|
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Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Dysphagia optimized intensity modulated radiotherapy (Do-IMRT) technique |
Contouring DARS (dysphagia and aspiration related structures) as a separate OAR (organ at risk) and reducing the radiation dose to pharyngeal constrictors thereby hoping to lower the severity of dysphagia in these patients post radiation (severity of dysphagia in these patients will be compared to those who received standard intensity modulated radiotherapy)
Dose - Hypopharynx primary
Inferior Pharyngeal Constrictor - Mean 50Gy
Superior/Middle Pharyngeal Constrictor - Mean 40Gy
Dose - Oropharynx primary
Inferior Pharyngeal Constrictor - Mean 20Gy
Superior/Middle Pharyngeal Constrictor - Mean 50Gy
Total Dose - 66Gy in 33 fractions
Frequency - One fraction per day - Five fractions per week (Monday to Friday) for a total of 33 fractions
Total duration - 6.5 weeks treatment
|
| Comparator Agent |
Standard intensity modulated radiotherapy (S-IMRT) technique |
Assessing the severity of dysphagia in these patients in whom DARS (dysphagia and aspiration related structures) was not contoured as a separate organ at risk (OAR) as in standard treatment technique - severity of dysphagia in these patients will be compared to those receiving dysphagia optimized intensity modulated radiotherapy
Pharyngeal constrictor muscles - Not contoured separately
Total Dose - 66Gy in 33 fractions
Frequency - One fraction per day - Five fractions per week (Monday to Friday) for a total of 33 fractions
Total duration - 6.5 weeks treatment
|
|
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Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
1) Patients with stage T2-T4, N+, M0 carcinoma of oropharynx, hypopharynx or larynx with squamous cell carcinoma histology only
2) ECOG performance 0-2
3) Written informed consent.
|
|
| ExclusionCriteria |
| Details |
• Patients with head and neck cancer with non-squamous cell carcinoma histology
• Cancer sites other than oropharynx, hypopharynx, or supraglottic larynx
• Patients with T1 N0 M0 (or M1) disease in the above-mentioned sites
• Patients with recurrent cancer in the above-mentioned sites
• Patients not fit for concurrent chemoradiation (or receiving chemotherapy other than weekly cisplatin)
• Documented evidence of pre-existing swallowing dysfunction (not related to cancer)
• Previous radiotherapy to the head and neck region
• ECOG performance 3-4
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Severity of dysphagia |
3 months post radiation |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Treatment response |
Comparison of pre-treatment PET-CT scan with post-treatment PET-CT scan |
|
|
Target Sample Size
|
Total Sample Size="40" Sample Size from India="40"
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)
|
06/09/2021 |
| 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)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
NIL |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Dysphagia
following chemoradiation for patients with head and neck cancers have led to a
devastating impact on their quality of life, as it leads to a change in the
type of diet, prolongation of meal times, or even a need for tube feeding. Although
other significant toxicities have been reduced by developments in radiation
techniques, dysphagia continues to be a challenge for radiation oncologists. Many
phase II studies have shown
that reducing the radiation dose to critical swallowing structures such as the
pharyngeal constrictor muscle and supraglottic larynx can lead to better
outcomes; however, there are limited prospective studies to have verified this
benefit. The aim of this study is to compare the effects of standard intensity
modulated radiotherapy (S-IMRT) and dysphagia-optimized intensity modulated
radiotherapy (Do-IMRT) on severity of dysphagia as
well as immediate treatment response in patients
undergoing concurrent chemoradiation for oropharyngeal, hypopharyngeal, and
supraglottic laryngeal cancer (T2-T4, N+, M0). The swallowing
function will be assessed by means of a modified barium swallow technique
performed six months after
treatment and the treatment response will be assessed by comparing the PET-CT
scan taken six months after
treatment with the pre-treatment PET-CT scan. |