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Role of High dose Ifosfamide in relapsed metastatic synovial sarcoma

A phase II study of single agent high dose ifosfamide in relapsed metasatic synovial sarcoma - NIL

Status
Active, not recruiting
Phases
Phase 2
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2024/03/063743
Enrollment
18
Registered
2024-03-06
Start date
Unknown
Completion date
Unknown
Last updated
2024-04-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: C49- Malignant neoplasm of other connective and soft tissue

Interventions

Intervention1: high dose ifosfamide in relapsed metastatic synovial sarcoma: injection ifosfamide 3gram per metre square given for 4 days in a 21 day cycle for 4 cycles in relapsed metastatic synovial

Sponsors

All Inida Institute of Medical sciences
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Age 15 to 60 years Synovial sarcoma confirmed histologically Metastatic disease relapsed post first line of chemotherapy ECOG Performance status less than or equal to 2 Absolute Neutrophil Count more than 1000 per microliter Hemoglobin more than 8 gram per deciliter Platelet more than 100000 per microliter normal Creatinine and clearence more than 60 milliliter per minute Total bilirubin less than institutional upper limit of normal Alanine aminotransferase and aspartate aminotransferase less than 5 times upper limit of normal alkaline phosphatase less than 2.5 times upper limit of normal

Exclusion criteria

Exclusion criteria: Pregnant or breast-feeding patient Active or uncontrolled infection Locally recurrent disease which is amenable to curative surgical resection Prior therapy taken for the synovial sarcoma with high dose ifosfamide Prior grade 3 or 4 renal toxicities and any grade of encephalopathy with ifosfamide

Design outcomes

Primary

MeasureTime frame
OVERALL RESPONSE RATETimepoint: at 3 months

Secondary

MeasureTime frame
median progression free survival overall survival quality of lifeTimepoint: at 3 months

Countries

India

Contacts

Public ContactSameer Rastogi

All inidia institute of medical sciences

samdoc_mamc@yahoo.com9013231857

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026