| CTRI Number |
CTRI/2024/03/064914 [Registered on: 28/03/2024] Trial Registered Prospectively |
| Last Modified On: |
21/03/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Radiation Therapy |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
A study comparing Hypofractionated Radiotherapy (HART) with Conventional Fractionated Radiotherapy (CFRT) in Newly Diagnosed High Grade Glioma (HGG) |
|
Scientific Title of Study
|
A Pilot study comparing Hypofractionated Accelerated Radiotherapy (HART) Vs Conventional Fractionated Radiotherapy (CFRT) in Newly Diagnosed High Grade Glioma (HGG): A Randomised non-inferiority Trial |
| 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 Dharmendra Kumar Sah |
| Designation |
Junior Resident |
| Affiliation |
POSTGRADUATE INSTITUTE OF MEDICAL EDUCATION AND RESEARCH |
| Address |
Room No.54, Ground floor, Nehru Hospital Extension, PGIMER, Sector 12, Chandigarh
Chandigarh
CHANDIGARH
160012
India |
| Phone |
9115188109 |
| Fax |
|
| Email |
shah.dharmendra2017@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Narendra Kumar |
| Designation |
Professor |
| Affiliation |
POSTGRADUATE INSTITUTE OF MEDICAL EDUCATION AND RESEARCH |
| Address |
Room No.54, Ground floor, Nehru Hospital Extension, PGIMER, Sector 12, Chandigarh
Chandigarh
CHANDIGARH
160012
India |
| Phone |
7087009393 |
| Fax |
|
| Email |
drnarendra74@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Dharmendra Kumar Sah |
| Designation |
Junior Resident |
| Affiliation |
POSTGRADUATE INSTITUTE OF MEDICAL EDUCATION AND RESEARCH |
| Address |
Room No.54, Ground floor, Nehru Hospital Extension, PGIMER, Sector 12, Chandigarh
Chandigarh
CHANDIGARH
160012
India |
| Phone |
9115188109 |
| Fax |
|
| Email |
shah.dharmendra2017@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of Radiotherapy and Oncology, Room No 54, Nehru Hospital Extension, PGIMER, Sector 12, Chandigarh |
|
|
Primary Sponsor
|
| Name |
Department of Radiotherapy and Oncology, Postgraduate Institute of Medical Education and Research |
| Address |
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 Dharmendra Kumar Sah |
Post Graduate Institute of Medical Education and Research |
Department of Radiotherapy and Oncology, Room No 54, Ground floor, Nehru Hospital Extension, Sector 12, Chandigarh
Chandigarh
CHANDIGARH |
9115188109
shah.dharmendra2017@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee, Post Graduate Institute of Medical Education and Research, 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 |
Radiotherapy |
In Arm A (CONVENTIONAL FRACTIONATED RADIOTHERAPY, CFRT) total dose of 60 Gy in 30 fractions at 2 Gy per fraction in 2 phases-
In phase 1 : Total dose of 46 Gy in 23 fractions over 4 ½ weeks followed by phase 2: 14Gy in 7 fraction over 1 ½ weeks (5 fractions per week, Monday to Friday).
Concurrent Temozolomide dosage will be given at 75mg/m2 daily 1 hour before RT, including Saturday, Sunday and holidays during Radiotherapy
During radiotherapy treatment patient will be reviewed weekly with CBC, RFT, LFT reports
Adjuvant Temozolomide will be given at 150-200mg/m2 from Day 1 to 5, for at least 6 cycles at 4 weekly interval starting 4 weeks after Radiotherapy completion.
 
|
| Intervention |
Radiotherapy |
In Arm B (HYPOFRACTIONATED ACCELERATED RADIOTHERAPY, HART), Total dose 60Gy in 20 fraction over 4 Wks at 3 Gy per fraction in 2 phases. In Phase I: 45Gy in 15 fraction over 3 wks and in Phase 2: 15Gy in 5 fraction over 1 week. Concurrent Temozolomide will be given at 75mg/kg 1 hour before Radiotherapy and on Saturday, Sunday and other public holidays.
During radiotherapy treatment patient will be reviewed weekly with CBC, RFT and LFT reports.
Adjuvant Temozolomide will be given at 150-200mg/m2 D1-D5 for at least 6 cycles at 4 weekly interval starting 4 weeks after radiotherapy completion.
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
1. Histologically confirmed cases of high grade gliomas: Anaplastic Astrocytoma (Grade 3), Astrocytoma (grade 4), Glioblastoma (Grade 4)
2. Age ≥ 18 years
3. KPS ≥ 70
4. Adequate renal, hepatic and hematologic function
5. Patients willing to participate in the study
|
|
| ExclusionCriteria |
| Details |
1. Pregnancy
2. Previous history of chemoradiation
3. Other primary, recurrent or metastatic disease
4. Patients with significant life-threatening co-morbidities
5. History of acute or chronic liver disease
|
|
|
Method of Generating Random Sequence
|
Permuted block randomization, fixed |
|
Method of Concealment
|
Case Record Numbers |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
1. Response rate as per RANO criteria at 3, 6, 9 months of treatment.
2. Progression Free survival (PFS) at 9 months
3. Overall Survival (O.S.) between the 2 arms at 9 months
4. Comparison of quality of life between two arms
5. Recurrence patterns of the two arms
|
At 3,6,9 months
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Recurrence pattern in 2 arm |
At 3,6,9 months |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
Final Enrollment numbers achieved (Total)= "80"
Final Enrollment numbers achieved (India)="80" |
|
Phase of Trial
|
Phase 2/ Phase 3 |
|
Date of First Enrollment (India)
|
01/04/2024 |
| Date of Study Completion (India) |
01/04/2025 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="1"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
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
|
Patient will be fully explain about the trial in their own language about the disease he is suffering from and possible modalities of treatment in their own language. Then patient consent will be take by informing possible outcome and reactions from treatment. Consent will be taken in fully conscious state. Patient will have right to withdraw from trial at any point of time if they wish. Patient wont be able to take any economical benefit by enrolling in the trial. Patient will kept on close follow-up and after treatment. Privacy of patient won’t be affected during and after treatment |