Title: A Novel Single Arm Phase II Study for Relapsed Germ Cell Tumours with Poor Prognosis
Disease site: Germ cell tumours
Status: Closed

Trial Design: The treatment of germ cell tumours is considered to be one of the major successes in the area of cytotoxic chemotherapy. Even in patients who relapse after first line therapy, a durable remission rate of between 25% and 60% has been seen using further chemotherapy. In 1999, researchers at St Bartholomew's Hospital developed the GAMEC protocol (combination chemotherapy with filgrastim, actinomycin D, methotrexate, etoposide, cisplatin). Results from this study showed that 50% of patients with relapsed testicular cancer could be cured using this treatment. When individual patients were reviewed it was clear that older patients (>35yrs) or patients with a raised Lactate Dehydrogenase, did not do as well. In addition, patients whose original tumour started in their chest (mediastinal germ cell tumour) tended to do badly if they relapsed. GAMMA will use paclitaxel instead of irinotecan and oxaliplatin instead of cisplatin. It is expected that this treatment with oxaliplatin will be less damaging to the kidneys than cisplatin. Both oxaliplatin and paclitaxel and oxaliplatin and irinotecan have similar activity in relapsed patients in the phase II setting. We hope to improve on our previous results with this substitution and see if this will lead to an improvement in the cure rate of relapsed germ cell tumours with poor prognosis and reduce the side effects compared to our standard treatment.

Trial details

Chief Investigator: Dr J. Shamash
Trial contact:
Clinical NCT01782339
EudraCT: 2010-022795-31
Sponsor: Barts Health NHS Trust
Participating countries: UK

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