| CTRI Number |
CTRI/2026/02/104742 [Registered on: 25/02/2026] Trial Registered Prospectively |
| Last Modified On: |
02/06/2026 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Ambispective study |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Study of treatment outcomes and relapse patterns in patients with Ewing’s sarcoma involving the brain or spinal cord coverings. |
|
Scientific Title of Study
|
Ewing’sSarcoma with Intradural Involvement: An Ambispective Study |
| 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 Jifmi Jose Manjali |
| Designation |
Associate Professor, Radiation Oncology |
| Affiliation |
Tata Memorial Hospital |
| Address |
Department of Radiation Oncology, Main Building ground floor opd 93
Tata Memorial Hospital,
Parel, Mumbai 400 012
Mumbai MAHARASHTRA 400012 India |
| Phone |
7045714838 |
| Fax |
|
| Email |
jifmijosemanjali@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Dr Jifmi Jose Manjali |
| Designation |
Associate Professor, Radiation Oncology |
| Affiliation |
Tata Memorial Hospital |
| Address |
Department of Radiation Oncology, Main Building ground floor opd 93
Tata Memorial Hospital,
Parel, Mumbai 400 012
Mumbai MAHARASHTRA 400012 India |
| Phone |
7045714838 |
| Fax |
|
| Email |
jifmijosemanjali@gmail.com |
|
Details of Contact Person Public Query
|
| Name |
Dr Jifmi Jose Manjali |
| Designation |
Associate Professor, Radiation Oncology |
| Affiliation |
Tata Memorial Hospital |
| Address |
Department of Radiation Oncology, Main Building ground floor opd 93
Tata Memorial Hospital,
Parel, Mumbai 400 012
Mumbai MAHARASHTRA 400012 India |
| Phone |
7045714838 |
| Fax |
|
| Email |
jifmijosemanjali@gmail.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.Ernst Borges Road, 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 Jifmi Jose Manjali |
Tata Memorial Hospital |
OPD 93, ground floor, Main Building Tata Memorial Hospital Dr.Ernst Borges Road, Mumbai
Mumbai MAHARASHTRA |
7045714838
jifmijosemanjali@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee I Tata Memorial Hospital Mumbai |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: C419||Malignant neoplasm of bone and articular cartilage, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
1.00 Year(s) |
| Age To |
99.00 Year(s) |
| Gender |
Both |
| Details |
1.Patients diagnosed with histologically proven Ewing’s sarcoma of the dura, and vertebral/paravertebral/Chest wall/calvarial/skull base with intradural extension
2.Treated with radical intent at TMH/ACTREC from January 2013 to December 2030 (Partly treated in TMH/ACTREC or treatment advised from here)
3.Any age
4.With at least 6 months of follow-up
|
|
| ExclusionCriteria |
| Details |
1.Patients treated with palliative intent
2.Less than 6 months of follow-up
3.Referred outside or defaulted for treatment
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To assess patterns of failure in patients with meningeal Ewing’s sarcoma either and patients with ewings sarcoma secondarily involvings the meninges. |
after completion of treatment during follow-up every 3 months for first 2 to3 years, every 6 months for next 2 years, and annually thereafter up to 5 years. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1.To assess outcomes [Local control (LC), Local Relapse Free Survival (LRFS), Disease Free Survival (DFS), Overall Survival (OS) in patients with meningeal sarcoma
2.To assess the relevance of systemic staging using FDG PET CECT
3.To assess prognostic factors for relapse
4.To compare LC, LRFS, DFS, OS & patterns of failure with vertebral/paravertebral/chestwall/calvarial/skull baseEwing’s sarcoma with intradural extension (secondary involvement)
|
At baseline,after completion of treatment; during follow-up every 3 months for first 2to3 years, every 6 months for next 2 years & annually thereafter up to 5 years. |
|
Target Sample Size
Modification(s)
|
Total Sample Size="680" Sample Size from India="680"
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)
|
09/03/2026 |
| 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="5" Months="0" Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| 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
|
Ewing’s sarcoma is a bone and soft tissue tumour commonly seen in children and young adults. Ewing’s sarcoma is primarily treated with a combination of chemotherapy and local therapy, which includes surgery and/or radiation therapy. About 20% of these tumours arise in extra-osseous sites, out of which 1-2% of tumours are dural-based lesions.Unlike peripheral PNETs, meningeal Ewing’s sarcomas are locally invasive and have a higher propensity for haematogenous spread to lungs and bone marrow. Among Ewing’s sarcoma, there is a possibility that meningeal Ewing’s sarcoma may behave differently as compared to other extraosseous sites. The recurrence rate in these cases ranges from 40-60%, distant craniospinal axis failure was reported in 41.2%, and two-year survival rates in the range of 30-60%.Owing to the rarity of meningeal Ewing’s sarcomas, the management protocol of these tumours is non-uniform, with few reports of craniospinal radiotherapy at presentation. There is a lack of definite uniform data on its patterns of relapse, outcomes, and underlying demographic characteristics. This ambispective study aims to contribute to the existing literature on meningeal Ewing’s sarcoma by understanding the clinical demographics, patterns of failure, outcomes and prognostic factors; thereby improving clinical decisions and facilitating improved treatment approaches. |