| CTRI Number |
CTRI/2025/07/091379 [Registered on: 22/07/2025] Trial Registered Prospectively |
| Last Modified On: |
22/07/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Checking Long-Term Narrowing of Neck Arteries in Head and Neck Cancer Patients After Radiotherapy |
|
Scientific Title of Study
|
CRoss-sectional study assessing long term carotid Artery Stenosis in Head and neck cancer
patients receiving radiotherapy to neck. (CRASH Study) |
| Trial Acronym |
CRASH |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Monali swain |
| Designation |
Professor, Radiation oncology |
| Affiliation |
head and neck DMG |
| Address |
HBB 205, Tata memorial hospital,Parel east,Mumbai
Mumbai (Suburban)
MAHARASHTRA
400012
India |
| Phone |
9920739863 |
| Fax |
|
| Email |
drmonaliswain@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr.Vishal Chavan |
| Designation |
Junior Resident |
| Affiliation |
Tata Memorial Hospital, Mumbai |
| Address |
HBB 205,2nd Floor, Department of Radiation Oncology Tata Memorial Hospital, Dr E Borges Road, Parel
Mumbai
MAHARASHTRA
400012
India |
| Phone |
9049312453 |
| Fax |
|
| Email |
vvishalchavan99@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Vishal Chavan |
| Designation |
Junior Resident |
| Affiliation |
Tata Memorial Hospital, Mumbai |
| Address |
HBB 205,2nd Floor, Department of Radiation Oncology Tata Memorial Hospital, Dr E Borges Road, Parel
Mumbai
MAHARASHTRA
400012
India |
| Phone |
9049312453 |
| Fax |
|
| Email |
vvishalchavan@gmail.com |
|
|
Source of Monetary or Material Support
|
| Tata Memorial Hospital, DR E. Borges marg, Parel, Mumbai, INDIA, 400012
Dr. E. Borges Marg,
Parel, Mumbai- 400012, INDIA |
|
|
Primary Sponsor
|
| Name |
TRAC |
| Address |
Dr. E Borges Road, Parel, Mumbai - 400 012 India |
| 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 Monali Swain |
Tata memorial hospital |
HBB 205, tmh,Dr. E. Borges Marg,
Parel, Mumbai , INDIA
Mumbai
MAHARASHTRA |
09920739863
drmonaliswain@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committe, IEC-I |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: C148||Malignant neoplasm of overlappingsites of lip, oral cavity and pharynx, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
NIL |
NIL |
| Comparator Agent |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
1 Cancers of oral cavity, Carcinoma of unknown primary, oropharynx, larynx and hypopharynx who have
received RT to unilateral or bilateral neck with or without concurrent Chemotherapy
2. Received RT dose to neck greater than 50GY
3. Patients treated with IMRT technique
4. Post RT at least 3 yr |
|
| ExclusionCriteria |
| Details |
1. Not received RT to neck
2. Those not treated with IMRT
3. Nasopharyngeal cancer
4. Less than 3yr from treatment completion.
5. T1-T2 glottis cancer
6. Received re-irradiation
7. Metastatic disease at presentation
8. Recurrent disease at the time of evaluation for CAS
7. Metastatic disease at presentation
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Prevalence of moderate and severe long-term RT induced CAS and corelation with RT dose in patients of head neck cancers who received RT to neck |
Post Radiation 3 years |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
NIL |
|
|
Target Sample Size
|
Total Sample Size="108"
Sample Size from India="108"
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
|
N/A |
|
Date of First Enrollment (India)
|
04/08/2025 |
| 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
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Patients of head and neck cancers receive radiotherapy as part of their treatment and radiation therapy can sometimes lead to a narrowing or thickening of the carotid arteries, a condition called carotid artery stenosis i.e. Narrowing of carotid artery leads to decreased blood supply to the brain and development of stroke. The risk of carotid artery stenosis increases with higher radiation doses, older age, smoking, and other health conditions like high blood pressure and diabetes. However, the condition may not cause symptoms in its early stages and remain asymptomatic in most patients. The risk of carotid artery increases as year passes by after radiotherapy. The overall risk of carotid artery stenosis is around 26%. There is no definitive guideline as to whether to evaluate this risk or not and when to do it, its impact on the survival of patients. Hence in this study, we aim to assess the rate and extent of carotid artery stenosis using a non-invasive method called USG Doppler. This study aimed to explore the effects of radiation treatment on the carotid arteries in patients who have been treated for head and neck cancer. The carotid arteries are the major blood vessels that supply blood to the brain, and damage to these arteries can lead to serious health problems, like stroke. By examining patients who have received radiation for head and neck cancer, this study sought to understand how common this narrowing of the arteries is, how severe it can get, and which factors may influence its development. The research involved analyzing the medical records and conducting tests to measure the degree of narrowing in the carotid arteries in a group of patients. The findings of this study could help doctors identify head and neck cancer patients who are at higher risk for carotid artery stenosis, enabling earlier detection and better management of this potential complication.
|