| CTRI Number |
CTRI/2024/02/062605 [Registered on: 14/02/2024] Trial Registered Prospectively |
| Last Modified On: |
28/02/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Follow Up Study |
| Study Design |
Other |
|
Public Title of Study
|
Antiepileptics in brain tumour |
|
Scientific Title of Study
|
Incidence of seizures after treatment completion and practice Patterns of anti-convulsant therapy in supratentorial brain tumors: an observational study |
| Trial Acronym |
IMPACT |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Tejpal Gupta |
| Designation |
Professor, Department of Radiation Oncology |
| Affiliation |
Tata Memorial Hospital |
| Address |
Tata Memorial Hospital,
Homi Bhabha Block,
Ground Floor OPD 056,
Parel, Mumbai
Mumbai
MAHARASHTRA
400012
India |
| Phone |
9821548980 |
| Fax |
|
| Email |
tejpalgupta@rediffmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Tejpal Gupta |
| Designation |
Professor, Department of Radiation Oncology |
| Affiliation |
Tata Memorial Hospital |
| Address |
Tata Memorial Hospital,
Homi Bhabha Block,
Ground Floor OPD 056,
Parel, Mumbai
Mumbai
MAHARASHTRA
400012
India |
| Phone |
9821548980 |
| Fax |
|
| Email |
tejpalgupta@rediffmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Tejpal Gupta |
| Designation |
Professor, Department of Radiation Oncology |
| Affiliation |
Tata Memorial Hospital |
| Address |
Tata Memorial Hospital,
Homi Bhabha Block,
Ground Floor OPD 056,
Parel,
Mumbai
Mumbai
MAHARASHTRA
400012
India |
| Phone |
9821548980 |
| Fax |
|
| Email |
tejpalgupta@rediffmail.com |
|
|
Source of Monetary or Material Support
|
| Tata Memorial Hospital,
Dr E Borges Road,
Parel,
Mumbai - 400012 |
|
|
Primary Sponsor
|
| Name |
Tata Memorial Hospital |
| Address |
Dr E Borges Road,
Parel, Mumbai- 400012 |
| 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 Tejpal Gupta |
Tata Memorial Hospital |
Homi Bhabha Block,
Dr E Borges Road,
Parel
Mumbai
MAHARASHTRA |
022-24177000
tejpalgupta@rediffmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee II |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: G938||Other specified disorders of brain, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Not Applicable |
Not Applicable |
| Intervention |
Not Applicable |
Not Applicable |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
Primary brain tumor with supratentorial location
Completed scheduled upfront treatment (Surgery or radiation or chemotherapy)
Age more than 18 years during diagnosis
Clinically and or radiologically controlled disease during study accrual
|
|
| ExclusionCriteria |
| Details |
Age less than 18 years during diagnosis of brain tumor
Infratentorial location
Primary spinal tumor
Patient with severe memory deficit and cannot recall prior history
Brain metastasis |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Incidence of seizure |
baseline and 6monthly upto 2yrs |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Progression free survival |
Till the time of disease progression |
| Overall survival |
At the completion of study |
| Factors influencing the incidence of seizures |
after treatment completion |
|
|
Target Sample Size
|
Total Sample Size="500"
Sample Size from India="500"
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)
|
01/03/2024 |
| 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="4"
Months="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
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
|
Primary brain tumors denote tumors originating inside the brain substance. Patients with primary brain tumors often develop seizures during diagnosis orduring the course ofthe disease. Antiepileptic drugs (AED) are used to reduce the risk of the development of seizures, both in patients with a previous history of seizures or without prior history (as prophylaxis). There are no well-established guidelines regarding the appropriate use of AEDs, choice of drugs, or duration of use. The practice pattern of AED is highly variable across different institutions. The most common AED in India (as obtained from a national survey) and also in our institution include levetiracetam. Other commonly used AEDs include phenytoin, brivaracetam, clobazam, and carbamazepine. Since a majority of patients are referred to our tertiary care center following the diagnosis of a brain tumor or after surgery, they are already on AEDs as per the preference of the primary physician. In our institution, we stop AED once the patient is free from any seizures for a duration of seizures. In the current observational study, we will include patients with primary brain tumors who have completed standard treatment for their disease. Patients accrued in the study will be followed up for a duration of 3 years, with brief interviews scheduled to record the use of AED and any seizure episodes. No additional visits are required for the current study, with the information collected during follow-up visits as per standard institutional practice. The study will have no influence on the treatment or use of AEDs (either drugs, duration, or discontinuation). Different clinical characteristics will be analyzed to understand the factors influencing the occurrence of seizures after treatment completion. |