| CTRI Number |
CTRI/2025/09/094953 [Registered on: 17/09/2025] Trial Registered Prospectively |
| Last Modified On: |
16/09/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug Radiation Therapy |
| Study Design |
Randomized, Parallel Group, Multiple Arm Trial |
|
Public Title of Study
|
Comparison of Response and Dosimetry between different Radiotherapy schedules in High Grade Glioma |
|
Scientific Title of Study
|
Comparison of Response and Dosimetry between Sequential Boost and Simultaneous Integrated Boost (with two different dose schedules) in Radiotherapy for High Grade Gliomas |
| 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 Shatarupa Chattopadhyay |
| Designation |
Assistant Professor, Radiation Oncology |
| Affiliation |
R G Kar Medical College and Hospital, Kolkata |
| Address |
Department of Radiation Oncolobgy, R G Kar Medical College, 1 Kshudiram Bose Sarani Kolkata WEST BENGAL 700004 India |
| Phone |
8910383179 |
| Fax |
|
| Email |
drshatarupadutta@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Dr Shatarupa Chattopadhyay |
| Designation |
Assistant Professor, Radiation Oncology |
| Affiliation |
R G Kar Medical College and Hospital, Kolkata |
| Address |
Department of Radiation Oncology R G Kar Medical College, 1 Kshudiram Bose Sarani Kolkata WEST BENGAL 700004 India |
| Phone |
8910383179 |
| Fax |
|
| Email |
drshatarupadutta@gmail.com |
|
Details of Contact Person Public Query
|
| Name |
Dr Shatarupa Chattopadhyay |
| Designation |
Assistant Professor, Radiation Oncology |
| Affiliation |
R G Kar Medical College and Hospital, Kolkata |
| Address |
Department of Radiation Oncology R G Kar Medical College, 1 Kshudiram Bose Sarani Kolkata WEST BENGAL 700004 India |
| Phone |
8910383179 |
| Fax |
|
| Email |
drshatarupadutta@gmail.com |
|
|
Source of Monetary or Material Support
|
| R G Kar Medical College, 1 Kshudiram Bose Sarani, Kolkata West Bengal 700004 |
|
|
Primary Sponsor
|
| Name |
Dr Shatarupa Chattopadhyay Dutta |
| Address |
1 Kshudiram Bose Sarani, Kolkata 700004 |
| Type of Sponsor |
Other [Self] |
|
|
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 Sandhya Narzary |
R G Kar Medical College |
Department of Radiation Oncology, R G Kar Medical College, 1 Kshudiram Bose Sarani, Kolkata, West Bengal 700004 Kolkata WEST BENGAL |
8910383179
drshatarupadutta@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institute Ethics Committee, R G Kar Medical College |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: C71||Malignant neoplasm of brain, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Sequential Boost |
Sequential Boost Radiotherapy with PTV1 46Gy/23#/5weeks followed by PTV2 Boost with 14Gy/7#/2weeks with Concurrent Temozolomide orally 75mg per m2 |
| Comparator Agent |
Simultaneous Integrated Boost 1 |
Simultaneous Integrated Boost Radiotherapy with PTV1 50Gy/25#/5weeks and PTV2 60 Gy/25#/weeks simultaneously with Concurrent Temozolomide orally 75mg per m2 |
| Comparator Agent |
Simultaneous Integrated Boost 2 |
Simultaneous Integrated Boost Radiotherapy with PTV1 51Gy/30#/6weeks and PTV2 60 Gy/30#/6weeks simultaneously with Concurrent Temozolomide orally 75mg per m2 |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
1. All patients of biopsy proven non metastatic high grade glioma
2. ECOG Performance Status 0 to 2.
3. Normal baseline hematological and biochemical parameters
4. Patients willing to provide informed consent with signature or left thumb impression for the approval for inclusion in the study.
|
|
| ExclusionCriteria |
| Details |
1. Evidence of distant metastasis by clinical or radiographic means.
2. Prior Radiotherapy
3. History of prior malignancy.
4. Pre-existing uncontrolled co-morbid medical conditions like Diabetes mellitus, cardiac ailments, neurological ailments for which deviation from oncological treatment protocol is required.
5. Patient refusal to undergo radiation.
6. Pregnancy or Lactation.
7. Other synchronous or metachronous primary malignancy.
8. Allergy to iodinated IV contrast or gadolinium.
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To compare response assessment, toxicity profiles, OS, PFS, dosimetric analysis and neurocognitive function in patients receiving Sequential Boost and Simultaneous Integrated Boost Radiotherapy (with two different dose schedules) in High Grade Gliomas |
24months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
NIL |
|
|
Target Sample Size
|
Total Sample Size="60" Sample Size from India="60"
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
|
Phase 3 |
|
Date of First Enrollment (India)
|
30/09/2025 |
| 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
|
High-grade
gliomas account for approximately 59% of all primary brain tumors in adults in
India. They are rapidly growing tumors that directly invade the
brain parenchyma but almost never metastasize outside the CNS. They present in
any age group, although most occur in late adulthood. GBM accounts for
approximately 75% of all high-grade gliomas. Treatment for high grade
gliomas involve a multidisciplinary approach which include neurosurgeons,
radiation oncologists, physicists and medical oncologists. However, high grade
gliomas carry poor prognosis with standard treatments, due to the nature of
disease and its close proximity to vital structure in the central nervous system. This
will be a single institutional, prospective, interventional study. Eligible
patients
of
high grade gliomas will undergo proper clinical examination, laboratory
and
imaging investigations. Three simultaneous radiation treatment plans will be
generated, one of Sequential Boost and two of Simultaneous Integrated Boost RT.
At the end of treatment planning, all the plans would be compared in terms of
Planning Total Volume coverage, sparing of Organs At Risk, Homogeneity Index
and Conformity Index. Patients would be followed up for response assessment,
toxicity profiles, OS, PFS, and neurocognitive function.
|