TIGER

• Research type

  Research Study

• Full title

  A RANDOMIZED PHASE III TRIAL COMPARING CONVENTIONAL-DOSE CHEMOTHERAPY USING PACLITAXEL, IFOSFAMIDE, AND CISPLATIN (TIP) WITH HIGH-DOSE CHEMOTHERAPY USING MOBILIZING PACLITAXEL PLUS IFOSFAMIDE FOLLOWED BY HIGH-DOSE CARBOPLATIN AND ETOPOSIDE (TI-CE) AS FIRST SALVAGE TREATMENT IN RELAPSED OR REFRACTORY GERM CELL TUMORS

• IRAS ID

  181655

• Contact name

  Deborah Piercy

• Contact email

  TIGER-icrctsu@icr.ac.uk

• Sponsor organisation

  European Organisation for Research and Treatment of Cancer

• Eudract number

  2014-003930-17

• Clinicaltrials.gov Identifier

  NCT02375204

• Duration of Study in the UK

  9 years, 0 months, 2 days

• Research summary

  TIGER is a multi-centre study in germ cell patients whose cancer has returned or become resistant to their initial chemotherapy. Its primary aim is to compare the overall survival in patients treated with high-dose chemotherapy, plus collection and reinfusion of the patients own stem cells, with those treated with conventional-dose chemotherapy.

  Germ cell tumours (GCT) represent the most common cancer affecting adolescents and
  young adult men in both Europe and the United States. Early stage disease, which affects the majority of GCT patients, is nearly universally curable with surgery or short-course chemotherapy therefore current efforts are focused on finding curative treatments which are less toxic.

  There is no international standard treatment in this setting and routine practice differs between countries. At present, the two major approaches for patients who require further treatment are high-dose chemotherapy with a stem cell transplant of the patients own cells or conventional-dose chemotherapy; due to a lack of conclusive randomised trials, it remains unclear which option represents the best treatment approach for these patients. Defining standards and optimising outcomes of salvage treatment thus represents one of the most pressing issues in the management of GCT at present.

• REC name

  London - Fulham Research Ethics Committee

• REC reference

  16/LO/1099

• Date of REC Opinion

  5 Aug 2016

• REC opinion

  Further Information Favourable Opinion