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CTRI Number  CTRI/2021/04/032867 [Registered on: 16/04/2021] Trial Registered Prospectively
Last Modified On: 02/12/2021
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Follow Up Study 
Study Design  Single Arm Study 
Public Title of Study   Radiotherapy for brain tumors 
Scientific Title of Study   Disease outcomes and treatment toxicities of hypofractionated radiotherapy for newly diagnosed high grade gliomas- A prospective observational study 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Sheel Mohanty 
Designation  Junior Resident 
Affiliation  KMC Manipal 
Address  Kasturba Medical College Manipal
Manipal
Udupi
KARNATAKA
576104
India 
Phone  7259627200  
Fax    
Email  sheel.oncology1234@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Krishna Sharan 
Designation  Professor and HOD 
Affiliation  KMC Manipal 
Address  Kasturba Medical College Manipal
Manipal
Udupi
KARNATAKA
576104
India 
Phone  9448625116  
Fax    
Email  tk.sharan@manipal.edu  
 
Details of Contact Person
Public Query  
Name  Dr Sheel Mohanty 
Designation  Junior Resident 
Affiliation  KMC Manipal 
Address  Kasturba Medical College Manipal
Manipal
Udupi
KARNATAKA
576104
India 
Phone  7259627200  
Fax    
Email  sheel.oncology1234@gmail.com  
 
Source of Monetary or Material Support  
Kasturba Medical College,Manipal 
 
Primary Sponsor  
Name  none 
Address  none 
Type of Sponsor  Other [none] 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Sheel Mohanty  Kasturba Medical College  Department of Radiation Oncology Shirdi Sai baba block Manipal Comprehensive Cancer Care Centre
Udupi
KARNATAKA 		 7259627200

sheel.oncology1234@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
IEC  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: G938||Other specified disorders of brain,  
 
Intervention / Comparator Agent  
Type  Name  Details 
 
Inclusion Criteria  
Age From  20.00 Year(s)
Age To  80.00 Year(s)
Gender  Both 
Details  Newly diagnosed high grade glioma post resection
Performance Score 2/5 
 
ExclusionCriteria 
Details  Recurrent disease
Poor Performance score 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Progression Free Survival  4 months,8 months and 12 months 
 
Secondary Outcome  
Outcome  TimePoints 
Overall Survival
Adverse effects of treatment 		 6 and 12 months 
 
Target Sample Size   Total Sample Size="32"
Sample Size from India="32" 
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)   19/04/2021 
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="2" 
Recruitment Status of Trial (Global)
Modification(s)  		 Not Applicable 
Recruitment Status of Trial (India)  Open to Recruitment 
Publication Details   https://doi.org/10.1056/nejmoa043330 https://link.springer.com/article/10.1007/s11060-011-0766-3#citeas. 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
Brief Summary   Hypofractionated radiotherapy is well-accepted alternative to conventionally fractionated long-course radiotherapy in elderly patients, and has been considered to have equivalent outcomes. In the wake of present pandemic situation that has constrained healthcare resources, there has been increasing adoption across multiple centers of hypofractionated radiotherapy schedules, significantly reducing the overall treatment time and thereby enhanced patient safety by ensuring reduced hospital visits, in addition to reducing the departmental workload. Moreover the hypofractionated regimen has also been shown to have comparable response rates. In our center hypofractionated radiotherapy has been increasingly adopted as an option for patients preferring a shorter course regimen. This study aims to report the outcomes of hypofractionated radiotherapy among patients who have preferred to undergo hypofractionated radiotherapy.

Detailed description of procedure/process:

Patients with high grade gliomas, following surgery and being planned for adjuvant radiotherapy, and meeting the eligibility criteria, will be explained about the options of conventional (60Gy/30-33#) and hypofractionated radiotherapy (40Gy/15#). They will be recruited if they are willing to participate in the study and provide voluntary informed consent for the same.

Radiotherapy planning will be done on MONACO Planning system as per the standard practice. Single phase treatment volume will be delineated on the planning CT as per standard guidelines(1).

If eligible, patients will also receive concurrent Temozolomide during RT, and 6 months of adjuvant Temozolomide thereafter, as per the standard practice.

The patient and treatment details will be recorded as per the proforma. They will be followed up following treatment as per the standard practice, of once in 3-4 months for the first two years, and less frequently thereafter.
 
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