| CTRI Number |
CTRI/2024/10/076093 [Registered on: 30/10/2024] Trial Registered Prospectively |
| Last Modified On: |
28/02/2026 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Retrospective study |
| Study Design |
Other |
|
Public Title of Study
|
Clinical outcomes of head and neck cancers treated with radical intent |
|
Scientific Title of Study
|
Clinical outcomes of head and neck cancers comprehensively treated with radical intent at HBCHRC Vishakhapatnam- A Retrospective Analysis |
| Trial Acronym |
NIL |
|
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, Radiation Oncology and Director |
| Affiliation |
Homi Bhabha Cancer Hospital and Research Center |
| Address |
Room no 105, Department of Radiation Oncology, Radiation Block, Homi Bhabha Cancer Hospital and Research Center, Aganampudi, Gajuwaka Mandalam, Visakhapatnam
Visakhapatnam
ANDHRA PRADESH
530053
India |
| Phone |
09819885774 |
| Fax |
|
| Email |
drumesh@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Rohit Avinash Vadgaonkar |
| Designation |
Associate Professor |
| Affiliation |
Homi Bhabha Cancer Hospital and Research Center |
| Address |
Room no 104, Department of Radiation Oncology, Radiation Block, Homi Bhabha Cancer Hospital and Research Center, Aganampudi, Gajuwaka Mandalam, Visakhapatnam
Visakhapatnam
ANDHRA PRADESH
530053
India |
| Phone |
917973783256 |
| Fax |
|
| Email |
dr.ravad@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Rohit Avinash Vadgaonkar |
| Designation |
Associate Professor |
| Affiliation |
Homi Bhabha Cancer Hospital and Research Center |
| Address |
Room no 104, Department of Radiation Oncology, Radiation Block, Homi Bhabha Cancer Hospital and Research Center, Aganampudi, Gajuwaka Mandalam, Visakhapatnam
Visakhapatnam
ANDHRA PRADESH
530053
India |
| Phone |
917973783256 |
| Fax |
|
| Email |
dr.ravad@gmail.com |
|
|
Source of Monetary or Material Support
|
| Homi Bhabha Cancer Hospital and Research Center, Tata Memorial Centre, Aganampudi, Gajuwaka Mandalam, Visakhapatnam, Andhra Pradesh 530053 |
|
|
Primary Sponsor
|
| Name |
Homi Bhabha Cancer Hospital and Research Center, Tata Memorial Centre, Visakhapatnam |
| 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 Rohit Avinash Vadgaonkar |
Homi Bhabha Cancer Hospital and Research Center |
Room no.105, Department of Radiation Oncology, Radiation Block,Homi Bhabha Cancer Hospital and Research Center, Aganampudi, Gajuwaka Mandalam
Visakhapatnam
ANDHRA PRADESH |
7972783256
dr.ravad@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| HBCHRC 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
|
| Type |
Name |
Details |
| Intervention |
NIL |
NIL |
| Comparator Agent |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
12.00 Year(s) |
| Age To |
90.00 Year(s) |
| Gender |
Both |
| Details |
All head and neck cancer patient comprehensively (received entire treatment in HBCH&RC) treated with radical intent at HBCH&RC |
|
| ExclusionCriteria |
| Details |
1. Received at least one radical intent of treatment outside HBCH&RC
2. Treated with palliative intent
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To assess clinico-epidemiological profile and outcomes of head and neck cancer patients comprehensively treated with radical intent at HBCHRC Vishakhapatnam |
2 years |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To assess the locoregional control (LRC) |
2years |
| To assess disease free survival (DFS) |
2years |
| To assess Overall survival (OS) |
2years |
| To assess p16 positivity by IHC |
2years |
| To assess acute & late toxicities |
2years |
| To find out prognostic factors associated with LRC, DFS & OS |
2years |
|
|
Target Sample Size
|
Total Sample Size="600"
Sample Size from India="600"
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)
|
11/11/2024 |
| 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="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Open to Recruitment |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
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
|
Head and neck cancers (HNC) are a heterogeneous group of cancers involving mucosal surfaces of the lip, tongue, oral cavity or mouth, oropharynx, nasopharynx, hypopharynx, pharynx not otherwise specified and larynx. Head and neck squamous cell carcinoma (HNSCC) accounts for more than 0.9 million cases and 0.4 million deaths worldwide. In India, there are more than 0.22 million cases and 0.12 million deaths according to the GLOBOCAN, 2020. Cancers of the lip and oral cavity are the second most common cancers following breast cancer. HNC constitutes 10.4% of the cancer burden and they account for 16.1% of cases in males and 4.8% of the cases in females. Information on cancer patterns and survival is essential for effective planning of cancer control interventions. Hence, we aimed at studying the clinico-epidemiological profile of HNC patients admitted in hospital from 2021 to 2023 and also to estimate the survival rate in them. This is a retrospective study with duration of 1 year and recruiting all the patients treated between 1st January, 2021 and 31st December, 2023 at Homi Bhabha Cancer Hospital and Research Centre, Visakhapatnam. Head and neck cancer patients who were treated comprehensively (received entire treatment in HBCH&RC) with radical intent will be included in our study. Outcomes will be measured as: Overall survival, Disease free survival, locoregional control, Pattern of care and Patterns of failure. |