| CTRI Number |
CTRI/2024/02/062620 [Registered on: 14/02/2024] Trial Registered Prospectively |
| Last Modified On: |
12/02/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Follow Up Study |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Clinical outcomes of locally advanced oral cavity cancers treated with definitive radiotherapy by VMAT technique |
|
Scientific Title of Study
|
Clinical outcomes of locally advanced oral cavity cancers treated with definitive volumetric modulated radiotherapy - A prospective single center study |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
M SUBHASH |
| Designation |
JUNIOR RESIDENT |
| Affiliation |
SRI VENKATESWARA INSTITUTE OF MEDICAL SCIENCES |
| Address |
Dept OF RADIATION ONCOLOGY
SVIMS, TIRUPATI
Chittoor
ANDHRA PRADESH
517507
India |
| Phone |
8123291565 |
| Fax |
|
| Email |
subbu.subhash.subhash@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Pranabandhu das |
| Designation |
Professor |
| Affiliation |
SVIMS TIRUPATI |
| Address |
Department of radiation oncology,
SVIMS
TIRUPATI
Chittoor
ANDHRA PRADESH
517507
India |
| Phone |
9493547731 |
| Fax |
|
| Email |
drpranabandhu79@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Pranabandhu das |
| Designation |
Professor |
| Affiliation |
SVIMS TIRUPATI |
| Address |
Department of radiation oncology,
SVIMS
TIRUPATI
L
Chittoor
ANDHRA PRADESH
517507
India |
| Phone |
9493547731 |
| Fax |
|
| Email |
drpranabandhu79@gmail.com |
|
|
Source of Monetary or Material Support
|
| Sri venkateswara institute of health science.
Tirupati.
517507 |
|
|
Primary Sponsor
|
| Name |
Sri venkateswara institute of medical science |
| Address |
Department OF RADIATION ONCOLOGY,
SVIMS,
ALIPIRI ROAD
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 M SUBHASH |
Sri venkateswara institute of medical science |
Department of radiation oncology,
Sri venkateswara institute of medical science
Tirupati
Chittoor
ANDHRA PRADESH |
8123291565
subbu.subhash.subhash@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional ethics committee, SVIMS Tirupati |
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
|
| Type |
Name |
Details |
| Comparator Agent |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
1. Histo-pathologically proven squamous cell carcinoma [SCC] of lips, buccal mucosa, tongue, gingiva, hard palate, retro molar trigone, floor of mouth.
2. Age : 18 -70 years .
3. Patients with eastern cooperative oncology group [ECOG] performance status of 0-2 .
4. Stage III to IVb SCC of oral cavity [american joint committee on cancer : 8th edition].
5. Patients with stage III to IVb SCC of oral cavity, not willing for surgery.
|
|
| ExclusionCriteria |
| Details |
1. Cancer with distant metastasis.
2. Patient with ECOG performance status of 3-4.
3. Patients who have undergone surgery.
4. Patients previously treated with radiotherapy to head & neck region.
5. Pregnant and lactating mothers.
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To estimate TUMOR RESPONSE in locally advanced oral cavity cancers treated by volumetric modulated arc radiotherapy with curative intent |
3 months post radiotherapy |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
• ACUTE TOXICITIES-
• Mucositis
• Dermatitis
• Dysphagia
• Xerostomia
|
Weekly during radiotherapy and monthly up to 3 months post radiotherapy |
• LATE TOXICITIES-
• Dysphagia
• Xerostomia
• Dermatitis
• Mucositis
|
Every 3 monthly up to 1 year post radiotherapy |
|
|
Target Sample Size
|
Total Sample Size="33"
Sample Size from India="33"
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)
|
24/02/2024 |
| 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="1"
Months="6"
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
|
As VMAT was recently adopted in our institute to treat malignancies , this study is being conducted to estimate tumor response and toxicities in locally advanced oral cavity cancers treated by volumetric modulated arc radiotherapy with curative intent. |