TIGER

Trial Title:

A Randomised Phase III Trial Comparing Conventional-Dose Chemotherapy Using Paclitaxel, Ifosfamide, and Cisplatin (TIP) with High-Dose Chemotherapy Using Mobilising Paclitaxel plus Ifosfamide Followed by High-Dose Carboplatin and Etoposide (TI-CE) as First Salvage Treatment in Relapsed or Refractory Germ Cell Tumours

Trial Acronym:

TIGER

Protocol Number:

ANZUP 1604

Trial Design:

Open-label, randomised, stratified, 2-arm, multi-centre phase 3 trial

Funding:

The Movember Foundation

Collaborators:

Alliance for Clinical Trials in Oncology (USA) and EORTC (Europe), NHMRC Clinical Trials Centre

ANZ Study Chair:

Peter Grimison

ANZ Coordinating Centre:

NHMRC Clinical Trials Centre

Trial Coordinator:

Anjali Bhardwaj

Trial Email:

tiger@ctc.usyd.edu.au

Patient Population:

Males from 14yo with refractory or relapsed germ cell tumours after 3-6 cycles of cisplatin-based first-line chemotherapy and ECOG PS 0-2


Intervention:

Arm A therapy will consist of 4 cycles of paclitaxel, ifosfamide, cisplatin and pegylated G-CSF administered every 21 days (+/- 4 days).

Arm B therapy will consist of 2 cycles (cycles 1-2) of paclitaxel, ifosfamide, and G-CSF followed by leukapheresis every 14 days. Then 3 cycles (cycles 3-5) of carboplatin, etoposide, stem cell reinfusion, and pegylated G-CSF every 21 days.

Primary Outcome:

Overall survival

Secondary Outcomes:

1. Progression free survival
2. Favourable response rate
3. Treatment related mortality
4. Toxicity
5. Validation of the International Prognostic Factor Study Group (IPFSG) Stratification System

Status:

Active and recruiting


Sites Recruiting:

NSW
  • Chris O'Brien Lifehouse (estimated to open fourth quarter 2018)
QLD
  • Princess Alexandra Hospital (open)
VIC
  • Box Hill Hospital (open)
  • Peter MacCallum Cancer Centre (estimated to open third quarter 2018)
INTERNATIONAL
  • Sites open in the USA, EORTC and UK

Further Information: Click Here
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