A Phase II Study of EVEROLIMUS in Patients With Primary or Relapsed Chondrosarcomas
Status:
Suspended
Trial end date:
2019-08-01
Target enrollment:
Participant gender:
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The treatments will be taken for 4 weeks before surgery, apart from any premature withdrawn