| CTRI Number |
CTRI/2025/03/083438 [Registered on: 25/03/2025] Trial Registered Prospectively |
| Last Modified On: |
19/03/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
A study to assess the benefit of Ifosfamide etoposide chemotherapy rechallenge in patients with relapsed Ewings sarcoma patients |
|
Scientific Title of Study
|
The role of Ifosfamide Etoposide rechallenge in recurrent relapsed Ewings Sarcoma |
| 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 Anand Shahi |
| Designation |
Senior Resident |
| Affiliation |
All India Institute Of Medical Sciences, New Delhi |
| Address |
Department of Medical Oncology, IRCH, All India Institute of Medical Sciences
Ansari Nagar East, New Delhi
South
DELHI
110049
India |
| Phone |
8601021559 |
| Fax |
|
| Email |
anand.shahi007@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Sameer Rastogi |
| Designation |
Additional Professor |
| Affiliation |
All India Institute of Medical Sciences, New Delhi |
| Address |
Department of Medical Oncology, Room 216, 2nd Floor, IRCH, All India Institute of Medical Sciences
Ansari Nagar East, New Delhi
South
DELHI
110049
India |
| Phone |
9958975343 |
| Fax |
|
| Email |
samdoc_mamc@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Anand Shahi |
| Designation |
Senior Resident |
| Affiliation |
All India Institute Of Medical Sciences, New Delhi |
| Address |
Department of Medical Oncology, IRCH, All India Institute of Medical Sciences
Ansari nagar east, New Delhi
South
DELHI
110049
India |
| Phone |
8601021559 |
| Fax |
|
| Email |
anand.shahi007@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of Medical Oncology, IRCH, All India Institute of Medical Sciences, Ansari nagar east, New Delhi, India, 110049 |
|
|
Primary Sponsor
|
| Name |
Department of Medical Oncology |
| Address |
IRCH, All India Institute of Medical Sciences, Ansari nagar east, New Delhi, India, 110049 |
| 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 Anand Shahi |
All India Institute Of Medical Sciences, New Delhi |
All India Institute of Medical Sciences, Ansari Nagar East, New Delhi
South
DELHI |
8601021559
anand.shahi007@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institute Ethics Committee for Postgraduate research, All India Institute of Medical Sciences, New Delhi |
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 |
Ifosfamide Etoposide chemotherapy |
Ifosfamide and Etoposide chemotherapy will be given to participants who fulfill the inclusion criteria
FREQUENCY - EVERY 3 WEEKS
DURATION - FOR A TOTAL OF 4 CYCLES FOLLOWED BY RESPONSE ASSESSMENT, IF RESPONSE, TO GIVE 2 MORE CYCLES FOR A TOTAL OF 6 CYCLES
CHEMOTHERAPY REGIMEN
Pre-medication (DAY 1- DAY 3)
Inj Ondansetron 16 mg IV
Inj Dexamethasone 8 mg IV
Inj Ranitidine 50 mg IV
Chemotherapy
Inj Ifosfamide 3000 mg/m2 IV in 2 units Normal Saline over 2 hours x 3 days
Inj Mesna 1000 mg/m2 IV Push at 0, 4, 8 hours of Ifosfamide x 3 days
Inj Etoposide 500 mg/m2 IV in 1 unit of D5% over 1 hour divided over 3 days
Post chemo
Tab Ondansetron 8 mg thrice daily till day 6
Tab Dexamethasone 8 mg twice daily to continue till day 6
Day 5-9: Inj G-CSF 5 microgram/kg (max dose of 300 mcg) subcutaneous once daily for 5 days
DOSE MODIFICATION AT BASELINE
25% dose reduction in patients with
Prior radiotherapy exposure
Grade 3/4 toxicity due to prior Ifosfamide-etoposide
Exposure to two or more lines of chemotherapy |
| Comparator Agent |
NOT APPLICABLE |
NOT APPLICABLE |
|
|
Inclusion Criteria
|
| Age From |
60.00 Month(s) |
| Age To |
50.00 Year(s) |
| Gender |
Both |
| Details |
Informed consent
Age of 5 to 50 years
Histologically proven Ewing’s sarcoma at initial diagnosis or recurrence
Distant or combined (local plus distant) relapse
Exposure to Ifosfamideand etoposide more than 12 months ago
Progression after atleast one line of treatment
ECOG PS 0-2
ANC more than 1000 per microlitre
Hemoglobin more than 8 g per dL
Platelet more than 1 lac per microlitre
Creatinine less than 1.5 times ULN
eGFR more than 30ml per min (Cockcroft-Gault)
Total bilirubin less than 5 times ULN
ALT and AST less than 5 times ULN, alkaline phosphatase less than 2.5 times ULN
|
|
| ExclusionCriteria |
| Details |
Cytotoxic chemotherapy within 2 weeks
Radiation therapy within 6 weeks
Active or uncontrolled infection
Isolated local recurrence amenable to curative surgical resection
Previous CTCAE v.5 grade 3 or 4 acute kidney injury / encephalopathy or neurotoxicity / myelosuppression due to prior ifosfamide or etoposide treatment
Active heart disease, uncontrolled hypertension and arterial or venous thrombotic disease
Pregnant or breastfeeding patient
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Objective Response Rate (Complete response plus Partial Response) Rates |
3 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Duration of Response
Progression Free Rate at 3 months
QoL
Side effect Profile
|
3 months and 6 months |
|
|
Target Sample Size
|
Total Sample Size="42"
Sample Size from India="42"
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)
|
31/03/2025 |
| 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="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
|
Background : Recurrent/relapsed Ewing’s sarcoma has a poor outcome, especially patients
with systemic relapse. Multiple regimens are used at progression, but none
have been established as the standard of care. According to a recent ongoing,
randomised trial, High dose ifosfamide was found to perform better in terms of
a better survival, albeit with higher toxicity rates and treatment
discontinuation.
The intent of the treatment in a recurrent setting is palliative, and should take
into account the side effects. Ifosfamide-etoposide rechallenge, after a
treatment free interval is an option, which may be safe and effective, and
improve the quality of life of these patients. IE is an established part of treatment in the first line setting, especially for non-metastatic ewing’s, however, there is no data regarding its use in the second line setting, especially in patients who have received VAC/IE in the first line setting. The current study will be done to assess the efficacy and safety of this
combination in the indian population.
Methodology The total sample size will be 42. Patients after an informed consent, Age of 5 to 50 years
with Histologically proven Ewing’s sarcoma at initial diagnosis or recurrence with Distant, combined (local plus distant) relapse or isolated local recurrence
which is unresectable upfront and with a Treatment free interval with Ifosfamide and etoposide more than 12
months , progressing after one or more lines of chemotherapy
with ECOG PS 0-2, and acceptable lab parameters as defined in the inclusion and exclusion criteria will be recruited. They will receive Ifosfamide etoposide every 21 days, with dose modification based on severity of toxicities, according to the mentioned criteria.
Outcomes Primary endpoint is the Objective Response rate, which will be based on response assessment with repeat Imaging, defined according to the RECIST criteria. Secondary outcomes to be evaluated, include, Duration of Response, Progression Free Rate at 3 months, quality of life and Side effect Profile. Patients with response to the chemotherapy will be given a total of 6 cycles. |