A Phase II Study of EVEROLIMUS in Patients With Primary or Relapsed Chondrosarcomas

Summary

The mainstay of chondrosarcoma treatment is a wide surgical resection. Unfortunately, this is a rare occurrence, and patients with incomplete resection have very poor therapeutic options. In this context, it becomes important to find new therapeutic strategies to slow down tumor progression and to reduce tumor size before resection. Pre-clinical and clinical data suggest that EVEROLIMUS should be efficient as adjuvant and neo-adjuvant therapy in chondrosarcoma. Then, investigators propose a phase II, randomized, open label study compounded by 3 arms (1:1:1) to assess efficiency of EVEROLIMUS as neo-adjuvant therapy in patients with primary or relapsed chondrosarcomas : ARM 1 = No treatment; ARM 2 = 2,5 mg Everolimus/day; ARM 3 = 10 mg Everolimus/day. The treatments will be taken for 4 weeks before surgery, apart from any premature withdrawn

Timeline

Start

2014-08-14

Primary completion

2018-08

Completion

2019-08

Outcome

Outcome not reported

Stopped: “The study was suspended since july 27th 2016 because of unavailability of Everolimus”

Publications

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Indications