| CTRI Number |
CTRI/2015/10/006268 [Registered on: 16/10/2015] Trial Registered Retrospectively |
| Last Modified On: |
21/04/2016 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Radiation Therapy |
| Study Design |
Non-randomized, Active Controlled Trial |
|
Public Title of Study
|
Study to evaluate the possibility of using different doses of brain radiotherapy according to the response of chemotherapy in a rare brain tumour. |
|
Scientific Title of Study
|
Study to evaluate the feasibility of response adapted whole brain radiotherapy after methotrexate based chemotherapy in patients of newly diagnosed primary CNS lymphoma |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Narayan Adhikari |
| Designation |
Junior Resident |
| Affiliation |
All India Institute of Medical Sciences |
| Address |
Room No 142, RT Ward, Dr. B.R. Ambedkar Institute Rotary Cancer Hospital, All India Institute of Medical Sciences, New Delhi, India
New Delhi
DELHI
110029
India |
| Phone |
9654188624 |
| Fax |
|
| Email |
drnadhikari@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Ahitagni Biswas |
| Designation |
Assistant Professor (Guide) |
| Affiliation |
All India Institute of Medical Sciences |
| Address |
Room No 142, RT Ward, Dr. B.R. Ambedkar Institute Rotary Cancer Hospital, All India Institute of Medical Sciences, New Delhi, India
New Delhi
DELHI
110029
India |
| Phone |
9013590854 |
| Fax |
|
| Email |
dr_ahitagni@yahoo.co.in |
|
Details of Contact Person
Public Query
|
| Name |
Narayan Adhikari |
| Designation |
Junior Resident |
| Affiliation |
All India Institute of Medical Sciences |
| Address |
Room No 142, RT Ward, Dr. B.R. Ambedkar Institute Rotary Cancer Hospital, All India Institute of Medical Sciences, New Delhi, India
New Delhi
DELHI
110029
India |
| Phone |
9654188624 |
| Fax |
|
| Email |
drnadhikari@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of Medical Oncology, Dr. B.R. Ambedkar Intitute Rotary Cancer Hospital, All India Institute of Medical Sciences, Ansari Nagar, New Delhi, Pin:110029 |
| Department of Neuroradiology, Dr. B.R. Ambedkar Intitute Rotary Cancer Hospital, All India Institute of Medical Sciences, Ansari Nagar, New Delhi, Pin:110029 |
| Department of Radiation Oncology, Dr. B.R. Ambedkar Intitute Rotary Cancer Hospital, All India Institute of Medical Sciences, Ansari Nagar, New Delhi, Pin:110029 |
|
|
Primary Sponsor
|
| Name |
All India Institute of Medical Sciences |
| Address |
Ansari Nagar, New Delhi-110029 |
| Type of Sponsor |
Government medical college |
|
|
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 Narayan Adhikari |
All India Institute of Medical Sciences |
Department of Radiation Oncology, Dr. B.R. Ambedkar Institute Rotary Cancer Hospital, Ansari Nagar, New Delhi-110029
New Delhi
DELHI |
9654188624
drnadhikari@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institute Ethics Committee for post graduate research, AIIMS |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
Biopsy proven, newly diagnosed, immunocompetent untreated primary CNS lymphoma patients, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Induction chemotherapy- five 14-day cycles with Inj Methotrexate 3.5g/m2 IV over 2 hours (day 1) with adequate hydration, alkalinization and leucovorin rescue, Inj Vincristine 1.4mg/m2 IV push(day 1), Cap Procarbazine 100mg/m2 OD(day 1 to 7, cycle 1,3 and 5)
Consolidation chemotherapy 2 cycles one month apart with Inj cytarabine 3gm/m2/day over 3 hours day 1 and day 2 |
MVP chemotherapy to all the patients is given followed by response adapted whole brain radiotherapy followed by consolidation chemotherapy |
| Intervention |
Reduced dose whole brain radiotherapy |
Reduced dose 23.4gy/13#/2.5weeks whole brain radiotherapy to those achieving complete response to methotrexate based chemotherapy |
| Comparator Agent |
Standard dose whole brain radiotherapy |
Standard dose of 45gy/25#/5weeks whole brain radiotherapy to those achieving partial response/ stable disease/progressive disease after methotrexate based chemotherapy |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
Newly diagnosed, not received any treatment for primary cns lymphoma previously, with performance status(PS) ECOG 0-3, biopsy proven disease, immunocompetent |
|
| ExclusionCriteria |
| Details |
Any comorbidity that compromises chemo-radiotherapy treatment |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Response rate, Progression free survival |
6 months, 2 years |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Overall survival, toxiciy profile, Neuropsychological profile, Pathological correlation with treatment outcomes |
2 years |
|
|
Target Sample Size
|
Total Sample Size="20"
Sample Size from India="20"
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 2 |
|
Date of First Enrollment (India)
|
15/07/2015 |
| 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="6"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
Publication Details
|
|
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
The primary objective of the study is to evaluate the feasibility of response adapted whole brain radiation therapy after methotrexate based chemotherapy in immunocompetent patients of newly diagnosed primary central nervous system (CNS) lymphoma. The secondary objectives are 1. To assess Epstein-Barr Virus (EBV) positivity and molecular subtype of lymphoma and their correlation with treatment outcome 2. To assess the toxicity profile, neurocognitive effects of treatment and serial changes in quality of life in patients of primary central nervous system lymphoma
The reduced dose whole brain radiotherapy in patients with complete response after methotrexate based polychemotherapy has yielded excellent outcomes in foreign studies. This kind of study has not been conducted in Indian context. This will benefit the complete responders of chemotherapy by reducing treatment related neurotoxicity thus improve quality of life in the patients of Primary CNS lymphoma without compromising disease control. We are also correlating EBV positivity, molecular subtyping with treatment outcomes which may open further doors of research for personalised treatment and novel therapies. We will be doing neurocognitive assessment using the neuropsychological test battery designed for Indian context according to international recommendations so it will effectively assess the treatment related neurotoxicity in Indian patients who are educationally, socioeconomically and linguistically different from Western population. |