| CTRI Number |
CTRI/2026/02/105023 [Registered on: 27/02/2026] Trial Registered Prospectively |
| Last Modified On: |
27/02/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Retrospective Study |
| Study Design |
Other |
|
Public Title of Study
|
Results of advanced radiation treatment in oral cavity cancer patients. |
|
Scientific Title of Study
|
VMAT for Oral Cavity Cancers Outcomes Analysis. |
| Trial Acronym |
VOCAL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Umesh Mahantshetty |
| Designation |
Professor |
| Affiliation |
Homi Bhabha Cancer Hospital and Research Centre, Aganampudi, Gajuwaka mandalam ,Visakhapatnam |
| Address |
Room no.104, Department of Radiation oncology , Radiation block, Homi Bhabha Cancer Hospital and Research Centre, Aganampudi , Gajuwaka Mandalam , Visakhapatnam
Visakhapatnam
ANDHRA PRADESH
533053
India |
| Phone |
9819885774 |
| Fax |
|
| Email |
drumeshm@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Pokuru Dolly Meghana |
| Designation |
PG Resident |
| Affiliation |
Homi Bhabha Cancer Hospital and Research Centre, Aganampudi, Gajuwaka mandalam , Visakahapatnam |
| Address |
Room no.105, Department of Radiation oncology , Radiation block, Homi Bhabha Cancer Hospital and Research Centre, Aganampudi , Gajuwaka Mandalam , Visakhapatnam
Visakhapatnam
ANDHRA PRADESH
533053
India |
| Phone |
7337280645 |
| Fax |
|
| Email |
drdollymeghana@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Umesh Mahantshetty |
| Designation |
Professor |
| Affiliation |
Homi Bhabha Cancer Hospital and Research Centre, Aganampudi, Gajuwaka mandalam ,Visakhapatnam |
| Address |
Room no.104, Department of Radiation oncology , Radiation block, Homi Bhabha Cancer Hospital and Research Centre, Aganampudi , Gajuwaka Mandalam , Visakhapatnam
Visakhapatnam
ANDHRA PRADESH
533053
India |
| Phone |
9819885774 |
| Fax |
|
| Email |
drumeshm@gmail.com |
|
|
Source of Monetary or Material Support
|
| Homi Bhabha Cancer Hospital and Research Centre, Unit of Tata Memorial Centre, Aganampudi, Gajuwaka mandalam, Visakhapatnam , Andhra Pradesh ,India,
pincode 530053 |
|
|
Primary Sponsor
|
| Name |
Homi Bhabha Cancer Hospital and Research Centre |
| Address |
Aganampudi, Gajuwaka Mandalam , Visakhapatnam , Andhra Pradesh , 530053 |
| 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 Pokuru Dolly Meghana |
Homi Bhabha Cancer Hospital and Research centre |
Room no 104, Radiation oncology department, Radiation block, Aganampudi, Gajuwaka Mandalam, Visakhapatnam ,Andhra Pradesh , India, pincode 530053
Visakhapatnam
ANDHRA PRADESH |
7337280645
drdollymeghana@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| HBCHRC Ethics committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: C039||Malignant neoplasm of gum, unspecified, (2) ICD-10 Condition: C009||Malignant neoplasm of lip, unspecified, (3) ICD-10 Condition: C029||Malignant neoplasm of tongue, unspecified, (4) ICD-10 Condition: C059||Malignant neoplasm of palate, unspecified, (5) ICD-10 Condition: C060||Malignant neoplasm of cheek mucosa, (6) ICD-10 Condition: C062||Malignant neoplasm of retromolar area, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
0.00 Year(s) |
| Age To |
99.00 Year(s) |
| Gender |
Both |
| Details |
histologically proven primary oral cavity squamous cell cancer who had undergone curative surgery and adjuvant VMAT based radiation therapy at HBCHRC , Visakhapatnam |
|
| ExclusionCriteria |
| Details |
Patients who are operated outside of HBCHRC, Visakhapatnam
Patients with history of prior malignancy in head neck region
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To analyse patterns of disease failure after adjuvant VMAT based radiation therapy in oral cavity squamous cancer patients from january 1st 2020 to december 31st 2024 |
2 years |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To assess survival outcomes : Disease free survival (DFS), Overall survival (OS), Locregional recurrence Free survival(LRRFS)
To asesss documented acute and chronic toxicities
To assess prognostic factors associated with DFS, OS, LRRFS |
2 years |
|
|
Target Sample Size
|
Total Sample Size="250"
Sample Size from India="250"
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)
|
24/03/2026 |
| 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 Yet Recruiting |
| 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
|
Oral cavity cancers constitute major oncological burden globally, particularly India and require multidisciplinary management involving surgery, radiotherapy and chemotherapy . Despite multidisciplinary approach, oral cavity squamous cell cancers continues high rates of locoregional recurrence
This retrospective observational study aims to evaluate patterns of failure , toxicities and clinical outcomes in patients of oral cavity squamous cell cancers who received Adjuvant VMAT based radiation therapy at Homi Bhabha cancer Hospital and Research Centre (HBCHRC),Visakhapatnam between January 1st 2020 and December 31st 2024.
Data will be collected from Electronic medical records (EMR), Radiation Oncology Information Systems(ROIS) including demographic details, diagnostic workup, surgical and pathological findings, treatment details, toxicities, and disease outcomes. Primary objective of Patterns of failure will be evaluated according to MD Anderson criteria. and secondary objectives such as Survival outcomes and treatment related toxicities will be analysed.
The findings are expected to provide real world evidence and guide future institutional protocols and research initiatives. |