| CTRI Number |
CTRI/2024/06/069040 [Registered on: 18/06/2024] Trial Registered Prospectively |
| Last Modified On: |
06/06/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Radiation Therapy |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Impact of radiotherapy and radiotherapy technique on neurocognitive profile in grade 2 and 3 gliomas. |
|
Scientific Title of Study
|
Prospective randomized study to evaluate the impact of radiotherapy and radiotherapy technique on neurocognitive profile in grade 2 and 3 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 Aditya Mehta |
| Designation |
Junior Resident |
| Affiliation |
Post Graduate Institute of Medical Education and Research, (PGIMER), CHANDIGARH |
| Address |
Room no. 54, Nehru Hospital Extension, Department of Radiotherapy and Oncology, PGIMER CHANDIGARH, Sector 12, Chandigarh-160012
Chandigarh
CHANDIGARH
160012
India |
| Phone |
7000020208 |
| Fax |
|
| Email |
amadityajain@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr. Shikha Goyal |
| Designation |
Assistant Professor |
| Affiliation |
Post Graduate Institute of Medical Education and Research, (PGIMER), CHANDIGARH |
| Address |
Room no. 54, Nehru Hospital Extension, Department of Radiotherapy and Oncology, PGIMER CHANDIGARH, Sector 12, Chandigarh-160012
Chandigarh
CHANDIGARH
160012
India |
| Phone |
8826136224 |
| Fax |
|
| Email |
drshikhagoyal@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Aditya Mehta |
| Designation |
Junior Resident |
| Affiliation |
Post Graduate Institute of Medical Education and Research, (PGIMER), CHANDIGARH |
| Address |
Room no. 54, Nehru Hospital Extension, Department of Radiotherapy and Oncology, PGIMER CHANDIGARH, Sector 12, Chandigarh-160012
CHANDIGARH
160012
India |
| Phone |
7000020208 |
| Fax |
|
| Email |
amadityajain@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of Radiotherapy and Oncology,
Room no. 54, Nehru Hospital Extension,
Postgraduate Institute of Medical Education and Research(PGIMER), Chandigarh,
Sector 12, Chandigarh
PIN code - 160012 |
|
|
Primary Sponsor
|
| Name |
Post Graduate Institute of Medical Education and Research PGIMER Chandigarh |
| Address |
Post Graduate Institute of Medical Education and Research (PGIMER) Chandigarh, SECTOR 12, CHANDIGARH, 160012 |
| 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 Aditya Mehta |
Post Graduate Institute of Medical Education and Research (PGIMER) Chandigarh |
Room no. 54, Nehru Hospital Extension, Department of Radiotherapy and Oncology, PGIMER CHANDIGARH, Sector 12, Chandigarh-160012
Chandigarh
CHANDIGARH |
7000020208
amadityajain@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Postgraduate Institute of Medical Education and Research, Chandigarh, Institutional Ethics Committee |
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 |
| Comparator Agent |
3D conformal radiotherapy. |
Other group will receive radiotherapy treatment by 3D conformal radiotherapy at dose of 54Gy-60Gy at 2Gy per fraction over 5.5 weeks to 6 weeks |
| Intervention |
Hippocampus sparing volumetric modulated arc therapy. |
one group will receive radiotherapy treatment with Hippocampus sparing volumetric modulated arc therapy, dose of 54Gy-60Gy at 2Gy per fraction over 5.5 weeks to 6 weeks |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1.Patients with infiltrative lower grade gliomas (grade 2-3) who have undergone tumor removal or at least biopsy with histopathologic confirmation.
2.Cranial radiotherapy is clinically indicated to prevent recurrence due to presence of high risk features (astrocytoma histology), subtotal resection (STR) or age older than 40 years.
3.Karnofsky Performance Status Scale score (KPS)
more than or equal to 60.
4.No prior history of radiation to the brain.
5.No contraindications to contrast enhanced computed tomography (CECT) and contrast enhanced magnetic resonance imaging (CEMRI).
6.Routine blood parameters (Complete blood count (CBC), liver function test (LFT), kidney function test (KFT)) within normal limits.
7.Willing to give consent for the study.
|
|
| ExclusionCriteria |
| Details |
1)Any non malignant known CNS disease that can cause neurocognitive dysfunction.
2)Pregnant and lactating women.
3)Prior long term chemotherapy.
4)Moderate or severe neurocognitive dysfunction prior to radiotherapy (MMSE less than or equal to 18)
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Case Record Numbers |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Change in neurocognitive function |
pre radiotherapy treatment
post radiotherapy treatment
3 months after radiotherapy treatment
6 months after radiotherapy treatment |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Change in Quality of life |
Before radiotherapy treatment
after radiotherapy treatment
3 months after radiotherapy treatment.
6 months after radiotherapy treatment. |
| Change in Depression, Anxiety & Stress Scale - 21 Items (DASS-21). |
Before radiotherapy treatment
after radiotherapy treatment
3 months after radiotherapy treatment.
6 months after radiotherapy treatment. |
|
|
Target Sample Size
|
Total Sample Size="70"
Sample Size from India="70"
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)
|
15/07/2024 |
| 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="1"
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
|
Patients who need adjuvant chemoradiation after surgical
intervention for lower grade gliomas would be assessed for neurocognitive
function before radiotherapy and its change longitudinally after therapy. We
aim to evaluate if radiotherapy causes neurocognitive
change, quantify the change and to assess if more conformal radiotherapy
techniques such as VMAT with hippocampal avoidance have a difference profile of neurocognitive function compared
to patients treated with 3DCRT without hippocampal avoidance. Also, we will
assess the quality of life in this group of patients longitudinally. |