Health Condition 1: C629- Malignant neoplasm of testis, unspecified whether descended or undescended
Conditions
Interventions
Intervention1: TIP regimen: Paclitaxel 250 mg per meter square intravenous on Day 1, Ifosfamide 1200 mg per meter square intravenous on Days 2 to 6, Cisplatin 20 mg per meter square intravenous on Day
Sponsors
ACTREC, TMC
Eligibility
Inclusion criteria
Inclusion criteria: 1. Histologically confirmed seminoma or non-seminoma TGCT 2. Patients with relapsed or refractory disease following first-line platinum-based chemotherapy. 3. Measurable disease per RECIST v1.1 and/or elevated serum tumor markers 4. ECOG PS 0 2 5. Adequate organ function
Exclusion criteria
Exclusion criteria: 1. Prior treatment with TIP or VeIP as systemic salvage chemotherapy 2. Prior high-dose chemotherapy with stem cell transplant 3. More than one prior line of systemic therapy 4. Active uncontrolled infection 5. Clinically significant cardiac disease 6. Uncontrolled CNS metastases or leptomeningeal disease 7. Other active malignancy requiring systemic therapy 8. Grade greater than or equal to 2 peripheral neuropathy at baseline
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Progression free survivalTimepoint: 2 years | — |
Secondary
| Measure | Time frame |
|---|---|
| Overall Survival (OS) Objective Response Rate (ORR) Disease Control Rate (DCR) Incidence of adverse events Treatment delivery & dose intensity Quality of lifeTimepoint: Up to study completion After completion of treatment After completion of treatment During treatment period During treatment period Baseline, during treatment, & follow up | — |
Countries
India
Contacts
Public ContactDr Aditya Dhanawat
The Advanced Centre for Treatment, Research and Education in Cancer (ACTREC)
Outcome results
None listed