Safety Study of Preoperative Sunitinib and Radiation in Soft Tissue Sarcoma

• Status: Completed
• Trial end date: 2015-02-01
• Target enrollment: 0
• Participant gender: All

Summary

To evaluate the toxicity of sunitinib concurrently given with irradiation for preoperative treatment of locally advanced or recurrent soft tissue sarcoma.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Heidelberg University
• Collaborator: German Research Foundation
• Treatments: Sunitinib

Criteria

Inclusion Criteria:

• histologically proven soft tissue sarcoma of any histology but GIST, Angiosarcoma, dermatofibrosarcoma protuberans, Ewing Sarcoma or Embryonal Rhabdomyosarcoma

• patients with primary tumors OR with local recurrences who did not receive prior radiation therapy OR with solitary metastatic lesions may be included

• complete resection after neoadjuvant treatment is expected

• age of 18 or older

• ECOG performance score 0 or 1

• normal organ and bone marrow function

• ability to give written informed consent

Exclusion Criteria:

• medication with inhibitors or inducers of CYP3A4

• prior therapy with tyrosine kinase inhibitors or conventional chemotherapy within 4 weeks before study inclusion

• history of myocardial infarction, stroke or thromboembolic events

• clinical signs of heart failure (NYHA 3 or 4)

• anticoagulation with Vitamin K antagonists

• acquired or hereditary coagulopathy

• uncontrolled hypertension

• uncontrolled intercurrent illness

• women who are pregnant or breastfeeding