| CTRI Number |
CTRI/2026/02/104537 [Registered on: 23/02/2026] Trial Registered Prospectively |
| Last Modified On: |
22/02/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Retrospective Study |
| Study Design |
Other |
|
Public Title of Study
|
A Study of Treatment Methods and Survival Outcomes in Patients with Glioma (Brain Tumor) Treated with Curative Therapy |
|
Scientific Title of Study
|
Glioma outcomes and benchmark evaluation at HBCHRC, Vizag-GLOBE |
| Trial Acronym |
NILL |
|
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 |
| Address |
Room No. 104, Department of Radiation Oncology, Radiation block, Homi Bhabha Cancer Hospital and Research Centre, Aganampudi, Gajuwaka Mandalam, Visakhapatnam
ANDHRA PRADESH
530053
India
Visakhapatnam ANDHRA PRADESH 533053 India |
| Phone |
9819885774 |
| Fax |
|
| Email |
drumeshm@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Dr Samyak Jain |
| Designation |
PG Resident |
| Affiliation |
Homi Bhabha Cancer Hospital and Research Centre |
| Address |
Room No. 105, Department of Radiation Oncology, Radiation block, Homi Bhabha Cancer Hospital and Research Centre, Aganampudi, Gajuwaka Mandalam, Visakhapatnam
ANDHRA PRADESH
530053
India
Visakhapatnam ANDHRA PRADESH 533053 India |
| Phone |
8899982286 |
| Fax |
|
| Email |
samragnarokjain@gmail.com |
|
Details of Contact Person Public Query
|
| Name |
Dr Umesh Mahantshetty |
| Designation |
Professor |
| Affiliation |
Homi Bhabha Cancer Hospital and Research Centre |
| Address |
Room No. 104, Department of Radiation Oncology, Radiation block, Homi Bhabha Cancer Hospital and Research Centre, Aganampudi, Gajuwaka Mandalam, Visakhapatnam
ANDHRA PRADESH
530053
India
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, Tata Memorial Centre, Aganampudi, Gajuwaka Mandalam, Visakhapatnam, Andhra Pradesh, 533053, India |
|
|
Primary Sponsor
|
| Name |
Homi Bhabha Cancer Hospital and Research Centre, Tata Memorial 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 Samyak Jain |
Homi Bhabha Cancer Hospital and Research Centre |
Room No. 104, Department of Radiation Oncology, Radiation block, Homi Bhabha Cancer Hospital and Research Centre, Aganampudi, Gajuwaka Mandalam, Visakhapatnam
ANDHRA PRADESH
530053
India Visakhapatnam ANDHRA PRADESH |
8899982286
samragnarokjain@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| HBCH RC Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: C719||Malignant neoplasm of brain, unspecified, |
|
|
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 |
Glioma cases who received at least one of the adjuvant treatment in HBCHRC, Vizag. |
|
| ExclusionCriteria |
| Details |
Patients who received EBRT outside HBCHRC
Patient with recurrent/progressive disease at presentation
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To evaluate patterns of care in patients with glioma treated at HBCHRC, Vizag over January 1st , 2020 till December 31st , 2024 |
2 Years |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. To assess compliance to planned treatment protocols.
2. To assess documentation, completeness of diagnostic and staging workup, including MRI, histopathology and molecular markers
3. To evaluate treatment related toxicities and unplanned treatment interruptions
4. To assess follow-up patterns and imaging surveillance post treatment
5. To identify prognostic factors influencing PFS (Progression Free Survival) and OS (Overall Survival)
6. To identify gaps in care delivery and areas of quality improvement
7. To propose recommendations/ action plans
8. To assess follow-up patterns and imaging surveillance post treatment
9. To assess response to treatment as per RANO criteria
|
2 Years |
|
|
Target Sample Size
|
Total Sample Size="150" Sample Size from India="150"
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)
|
22/03/2026 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
22/03/2026 |
| 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
|
Gliomas constitute the most common primary malignant brain tumors and require multidisciplinary management involving surgery, radiotherapy, and chemotherapy. While international guidelines emphasize molecular classification and quality indicators of care, real-world data on patterns of care, treatment compliance, and outcomes from Indian centers remain limited.
This retrospective observational study aims to evaluate patterns of care, quality indicators, treatment compliance, toxicities, and clinical outcomes in patients with glioma treated at Homi Bhabha Cancer Hospital and Research Centre (HBCHRC), Visakhapatnam, between January 2020 and December 2024. The study will benchmark institutional practices against guideline-based standards and identify gaps in care delivery.
Data will be collected from electronic medical records, radiology (PACS), and radiation oncology information systems (ROIS), including demographic details, diagnostic workup, surgical and pathological findings, molecular testing, treatment details, toxicities, follow-up patterns, and disease outcomes. Survival outcomes such as progression-free survival (PFS) and overall survival (OS) will be analyzed, and response assessment will be performed using RANO criteria.
The findings are expected to provide real-world evidence on glioma management, help identify areas for quality improvement, and guide future institutional protocols and research initiatives. |