| CTRI Number |
CTRI/2024/12/078648 [Registered on: 27/12/2024] Trial Registered Prospectively |
| Last Modified On: |
26/12/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Follow Up Study |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Retrospective audit of profile and Behaviour of Paediatric Ewings Sarcoma cancers |
|
Scientific Title of Study
|
A Retrospective Correlative Study of Clinicopathological Parameters with Disease Outcome in Ewings Sarcoma Patients Treated with Radiotherapy in a Tertiary Care Centre. |
| 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 Ashutosh Mukherji |
| Designation |
Professor and Head of Department |
| Affiliation |
Mahamana Pandit Madan Mohan Malaviya Cancer Centre and Homi Bhabha Cancer Hospital |
| Address |
Office of Head of Department,
Dept of Radiation Oncology,
Mahamana Pandit Madan Mohan Malaviya Cancer Centre and Homi Bhabha Cancer Hospital,
Sundar Bagiya, Naria
Varanasi
Varanasi
UTTAR PRADESH
221005
India |
| Phone |
9489146747 |
| Fax |
|
| Email |
drashutoshm@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Minesh Patel |
| Designation |
Junior Resident |
| Affiliation |
Mahamana Pandit Madan Mohan Malaviya Cancer Centre and Homi Bhabha Cancer Hospital |
| Address |
Office of Head of Department,
Dept of Radiation Oncology,
Mahamana Pandit Madan Mohan Malaviya Cancer Centre and Homi Bhabha Cancer Hospital,
Sundar Bagiya, Naria
Varanasi
Varanasi
UTTAR PRADESH
221005
India |
| Phone |
8347748925 |
| Fax |
|
| Email |
mineshpatel.411@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Ashutosh Mukherji |
| Designation |
Professor and Head of Department |
| Affiliation |
Mahamana Pandit Madan Mohan Malaviya Cancer Centre and Homi Bhabha Cancer Hospital |
| Address |
Office of Head of Department,
Dept of Radiation Oncology,
Mahamana Pandit Madan Mohan Malaviya Cancer Centre and Homi Bhabha Cancer Hospital,
Sundar Bagiya, Naria
Varanasi
Varanasi
UTTAR PRADESH
221005
India |
| Phone |
9489146747 |
| Fax |
|
| Email |
drashutoshm@gmail.com |
|
|
Source of Monetary or Material Support
|
| Mahamana Pandit Madan Mohan Malaviya Cancer Centre and Homi Bhabha Cancer Hospital,
Sundar Bagiya, Naria
Varanasi 221005
Uttar Pradesh, India |
|
|
Primary Sponsor
|
| Name |
Mahamana Pandit Madan Mohan Malaviya Cancer Centre and Homi Bhabha Cancer Hospital |
| Address |
Sundar Bagiya, Near Naria Gate, BHU Campus, Varanasi, Uttar Pradesh India 221005. |
| 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 Ashutosh Mukherji |
Mahamana Pandit Madan Mohan Malaviya Cancer Centre and Homi Bhabha Cancer Hospital, |
Office of Head of Department, Department of Radiation Oncology, Mahamana Pandit Madan Mohan Malaviya Cancer Centre and Homi Bhabha Cancer Hospital, Sundar bagiya, BHU Campus, Naria gate
Varanasi
UTTAR PRADESH |
9489146747
drashutoshm@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICS COMMITTEE (IEC) |
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 |
NA |
| Comparator Agent |
Nil |
NA |
|
|
Inclusion Criteria
|
| Age From |
1.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
1. Histopathologically confirmed Ewing’s sarcoma patient.
2. Non-Metastatic Ewing’s sarcoma patient except lung metastasis
3. Patients with Age more than 1 years or less than 80 years.
4. ECOG performance status 0-2
5. Patient with curative intent.
6. Patients with lung only metastasis or oligo metastatic disease with complete metabolic response post
NACT and treated with curative intent chemoradiotherapy will also be included. |
|
| ExclusionCriteria |
| Details |
1. Patients default during RT.
2. Histopathology other than Ewing’s Sarcoma.
3. Any patient not fitting into lung only or oligometastatic status.
4. Oligo metastatic disease without complete metabolic response post NACT in metastasis site will be
excluded.
5. Patients who are planned for palliative dose of RT |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
To correlate pre and post NACT tumor volume, extent of necrosis post NACT, pathological complete
response, type of RT i.e. radical/ adjuvant and with PFS and OS of Ewing Sarcoma. |
at 1 year post treatment |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Correlation of pre and post NACT PET CT SUVmax and metabolic factors with PFS and OS.
Other patient related factors like age, sex, site and treatment related factors like RT dose,
fractionation, lung bath etc will be correlated with short term outcomes. |
18 months |
|
|
Target Sample Size
|
Total Sample Size="120"
Sample Size from India="120"
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)
|
06/01/2025 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
06/01/2025 |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="1"
Months="6"
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
|
Ewing sarcoma is a malignant blue round cell tumour commonly arising from bone, but can arise from non-bony structures as well. This disease is usually treated with multimodal treatment including surgery, chemotherapy and radiotherapy. The disease outcome depends upon the disease characteristics and the treatment given. Here in this study we aim to study disease outcome in Ewing Sarcoma and its co relation with clinicopathological parameters and treatment. This study will be retrospective design including all patients of Ewing sarcoma treated from 1.1.2019 to 31.12.2023 with no additional risk to the patients. This study will be conducted at Homi Bhabha Cancer Hospital and Mahamana Pandit Madan Mohan Malaviya Cancer Centre, Varanasi. |