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 treatment in relapsed or refractory germ cell tumours.
Disease site: Testicular cancer, urological cancers
Treatment modality: Systematic therapy
Status: Open to recruitment
TIGER is a phase III, international, multicentre, randomised controlled trial comparing the use of conventional chemotherapy with high-dose chemotherapy as first treatment in patients with relapsed or refractory germ cell tumours.
Approximately 80 patients will be recruited from UK sites out of a worldwide total of 420 patients, over a four year period. Patients will be randomised to one of two treatment groups:
- conventional chemotherapy using the TIP regimen (paclitaxel, ifosfamide and cisplatin)
- or high-dose chemotherapy with autologous stem cell transplant using the TI-CE regimen (paclitaxel and ifosfamide followed by high-dose carboplatin and etoposide).
Patients will then be followed up for five years from randomisation.
UK Chief Investigator: Professor Robert Huddart, The Institute of Cancer Research and Royal Marsden NHS Foundation Trust
European Lead: Professor Thomas Powles, Barts Health NHS Trust
ICR-CTSU Scientific Lead: Dr Emma Hall
Trial management contact: [email protected]
ISRCTN: To be confirmed
European Sponsor: EORTC
U.S. Sponsor: Alliance
Funding: Cancer Research UK (CRUK/12/049)
Further information including recruitment progress is available from the following link:
Clinical Trials Gateway
Patient friendly information is available from the following link:
Cancer Research UK
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