TIGER

 Testicular — Recruiting

TIGER
This randomised phase III trial studies how well standard-dose combination chemotherapy works compared to high-dose combination chemotherapy and stem cell transplant in treating patients with germ cell tumours that have returned after a period of improvement or did not respond to treatment. Drugs used in chemotherapy, such as paclitaxel, ifosfamide, cisplatin, carboplatin, and etoposide, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving chemotherapy before a stem cell transplant stops the growth of cancer cells by stopping them from dividing or killing them. Giving colony-stimulating factors, such as filgrastim or pegfilgrastim, and certain chemotherapy drugs, helps stem cells move from the bone marrow to the blood so they can be collected and stored. Chemotherapy is then given to prepare the bone marrow for the stem cell transplant. The stem cells are then returned to the patient to replace the blood-forming cells that were destroyed by the chemotherapy. It is not yet known whether high-dose combination chemotherapy and stem cell transplant are more effective than standard-dose combination chemotherapy in treating patients with refractory or relapsed germ cell tumours.
If you think this trial might be right for you, please ask your doctor.
If you think this trial might be right for you, please ask your doctor.
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
Cancer Type
Testicular
Trial Status
Recruiting
Protocol Number
ANZUP 1604
Co-ordinating centre
Study Chair
A/Prof Peter Grimison
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
Recruitment Target
420 participants (internationally), 60 (ANZ)
Acknowledgements
The Movember Foundation
Detailed Information
Further Information
ClinicalTrials.gov
Participating Centres
NSW
Chris O'Brien Lifehouse - Sydney Local Health District

VIC
Eastern Health
Peter MacCallum Cancer Centre

QLD
Princess Alexandra Hospital

International
USA, EORTC,UK