| CTRI Number |
CTRI/2026/01/100163 [Registered on: 01/01/2026] Trial Registered Prospectively |
| Last Modified On: |
31/12/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Radiation Therapy |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
A Study utilising Radiotherapy of a higher dose of 74 Gray, involving patients of High Grade Brain tumours who have undergone surgery for the same, to see the Effects and Response of the Tumours to High Dose Radiotherapy. |
|
Scientific Title of Study
|
A Pilot Study to evaluate Failure Patterns after Escalated Dose Radiotherapy to 74 Gy in High Grade Glioma (HGG): A Prospective 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 |
Dr Chitran Chakrabortty |
| Designation |
Junior Resident |
| Affiliation |
Postgraduate Institute of Medical Education and Research (PGIMER), Chandigarh |
| Address |
Department of Radiotherapy and Clinical Oncology, Postgraduate Institute of
Medical Education and Research (PGIMER), Sector 12, Chandigarh
Chandigarh
CHANDIGARH
160012
India |
| Phone |
9051028380 |
| Fax |
|
| Email |
chitranchakrabortty@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Narendra Kumar |
| Designation |
Professor |
| Affiliation |
Postgraduate Institute of Medical Education and Research (PGIMER), Chandigarh |
| Address |
Department of Radiotherapy and Clinical Oncology, Postgraduate Institute of
Medical Education and Research (PGIMER), Sector 12, Chandigarh
Chandigarh
CHANDIGARH
160012
India |
| Phone |
7087009393 |
| Fax |
|
| Email |
drnarendra74@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Narendra Kumar |
| Designation |
Professor |
| Affiliation |
Postgraduate Institute of Medical Education and Research (PGIMER), Chandigarh |
| Address |
Department of Radiotherapy and Clinical Oncology, Postgraduate Institute of
Medical Education and Research (PGIMER), Sector 12, Chandigarh
Chandigarh
CHANDIGARH
160012
India |
| Phone |
7087009393 |
| Fax |
|
| Email |
drnarendra74@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of Radiotherapy and Clinical Oncology, Room no 54, Nehru Hospital Extension Block, Postgraduate Institute of Medical Education and Research (PGIMER), Sector 12, Chandigarh, PIN
code- 160012 |
|
|
Primary Sponsor
|
| Name |
Department of Radiotherapy and Clinical Oncology, PGIMER, Chandigarh |
| Address |
Department of Radiotherapy and Clinical Oncology, Postgraduate Institute of
Medical Education and Research (PGIMER), Sector 12, Chandigarh |
| 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 Chitran Chakrabortty |
Post Graduate Institute of Medical Education and Research, Chandigarh |
Department of Radiotherapy and
Clinical Oncology, Postgraduate Institute of Medical Education
and Research (PGIMER), Room
no 54, Nehru Hospital Extension Block, Sector 12, Chandigarh, PIN code- 160012
Chandigarh
CHANDIGARH
Chandigarh
CHANDIGARH |
9051028380
chitranchakrabortty@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee, Postgraduate Institute of Medical Education and Research (PGIMER), Chandigarh |
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 |
Cranial Radiation Therapy |
Cranial Radiation Therapy delivered by Volumetric Modulated Arc Therapy (VMAT) to a dose of 74 Gray in 37 fractions |
| Comparator Agent |
Not Applicable |
Not Applicable |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
Histologically confirmed post operative cases of High Grade Gliomas including Astrocytoma
Grade 3 or Grade 4, Glioblastoma Grade 4.
Age greater than or equal to 18 years.
KPS greater than or equal to 70.
Adequate renal, hepatic and hematologic function.
Patients willing to participate in the study with written and informed consent. |
|
| ExclusionCriteria |
| Details |
Pregnancy.
Previous history of chemoradiation.
Other primary, recurrent or metastatic disease.
Patients with significant life-threatening co-morbidities.
History of acute or chronic liver disease. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Failure Patterns. |
3 months, 6 months, 9 months. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Response Rate as per RANO criteria. |
3 months, 6 months, 9 months. |
| Overall Survival and Progression free Survival. |
9 months. |
| Quality of Life evaluation. |
3 months, 6 months, 9 months. |
| Radiotherapy induced Radionecrosis. |
6 months. |
| Impact of delayed T1 contrast enhance MRI on GTV. |
|
|
|
Target Sample Size
|
Total Sample Size="30"
Sample Size from India="30"
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)
|
01/02/2026 |
| 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="1"
Months="5"
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
|
Multiple studies have shown that majority of failures in Glioblastomas occur either centrally or within
the high dose field. This study aims to see the
effects of applying a higher radiation dose (74Gy) to the tumour alongside concurrent
chemotherapy to see the failure pattern thereafter. |