Mesothelioma Stellar Trial, Nvcr Ex991 6 Pptx Htm

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In vitro human mesothelioma cells were highly susceptible to ttfields. It is designed to test the efficacy and safety of a medical device the novottf 100l system in patients with malignant pleural mesothelioma when the device is combined with chemotherapy for mesothelioma. The trial accrued 80 patients with unresectable previously untreated mesothelioma.

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The primary endpoint was overall survival os.

Cupcake coloring pages free printable. The results of stellar suggest similarity with the data obtained from the nintedanib study where the randomized phase ii single armed study suggested benefit but which failed in the phase iii setting in mesothelioma. 45 not written in the stars yet the stellar trial reported a median os primary endpoint of 182 months 95 ci 121 258. Inclusion criteria included ecog ps of 0 1 and pathologically proven mesothelioma.

The device administers ttfields to patients concomitantly to the best. Ttfields have been shown to extend survival of patients with glioblastoma when added to chemotherapy. Stellar was a prospective single arm phase 2 trial done at 12 european academic and non academic sites five in italy three in poland one in france one in belgium one in spain and one in the netherlands for treatment naive patients with histologically confirmed unresectable malignant pleural mesothelioma.

Patients were treated with continuous 150 khz ttfields 18hday in combination with pemetrexed and cisplatin or carboplatin. The stellar trial was a prospective single arm trial including 80 patients that studied the use of tumor treating fields delivered via the novottf 100l system in combination with pemetrexed plus cisplatincarboplatin as a first line treatment for patients with unresectable locally advanced or metastatic malignant pleural mesothelioma mpm. All 80 study participants had mesothelioma that was unresectable meaning they were not candidates for surgery.

The stellar trial was used to test the effectiveness of novottf 100l in treating patients with malignant pleural mesothelioma in particular. 53 patients had epithelioid mesothelioma and 21 patients had non epithelioid cell types. Stellar final results of a phase 2 trial of ttfields with chemotherapy for first line treatment of pleural mesothelioma.

The stellar trial also known as the ef 23 trial is a pilot analogous to drug phase ii single arm trial.

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Mesothelioma Stellar Trial, Nvcr Ex991 6 Pptx Htm

The primary endpoint was overall survival os.

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