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The University of Southampton
Southampton Clinical Trials Unit

Gem-TIP Trial

Trial Name:

Gem-TIP - Phase I/II multicentre trial of salvage chemotherapy with Gem-TIP for relapsed germ cell cancer

Description:

Gem-TIP is a Phase II multi-centre trial of salvage chemotherapy with gemcitabine and TIP (Paclitaxel, Ifosfamide, Cisplatin) for relapsed germ cell cancer. This trial is for patients in first relapse following one previous cisplatin containing combination chemotherapy treatment for metastatic extracranial primary germ cell cancer.

Objectives:

Design:

Pre treatment investigations: Physical examination, full blood count, U&E, GFR, LFTs, AFP, HCG, LDH, Chest x-ray, CT head, chest, abdomen pelvis.

During chemotherapy: FBC twice weekly

Before each treatment cycle: WHO toxicity assessment, FBC, AFP, HCG, chest x-ray.

Post treatment assessment: CT of relevant sites, PET scan (optional), surgery as required

Status:

Completed

Population:

Patients in first relapse following one previous cisplatin containing combination chemotherapy treatment for metastatic extracranial primary germ cell cancer. Age range 16 – 60 years.

Publications:

Salvage chemotherapy with gemcitabine, paclitaxel, ifosfamide, and cisplatin for relapsed germ cell cancer

Contact details

All Trial enquiries should be addressed to ctu@soton.ac.uk

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