In Switzerland, soft tissue sarcomas account for around 1% of all cancers. Patients with a local advanced or metastatic soft tissue sarcoma (mSTS) have a very poor prognosis. Most of these patients receive palliative chemotherapy, usually with doxorubicin, either alone or in combination with other chemotherapy drugs.
In previous trials, gemcitabine has shown promising activity in mSTS. The SAKK 57/16 trial will therefore investigate how well tolerated and effective the combination of gemcitabine and nab-paclitaxel is in patients with an mSTS. Patients with an mSTS and at least one previous chemotherapy can take part in the trial, which will be carried out in two phases. In phase I, the dose-limiting toxicity of nab-paclitaxel (in combination with gemcitabine) will be investigated in 4-12 patients. In phase II, the effectiveness of the combination therapy will be investigated in around 39 patients. A maximum of 45 patients can be enrolled in the trial.