Status:
COMPLETED
Safety Study of Preoperative Sunitinib and Radiation in Soft Tissue Sarcoma
Lead Sponsor:
Heidelberg University
Collaborating Sponsors:
German Research Foundation
Conditions:
Soft Tissue Sarcoma
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief Summary
To evaluate the toxicity of sunitinib concurrently given with irradiation for preoperative treatment of locally advanced or recurrent soft tissue sarcoma.
Detailed Description
Although the introduction of multimodal treatment of soft tissue sarcoma resulted in great progress in STS treatment, local failure still occurs in 10-20% of STS patients. Therefore further improvemen...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
February 1 2012
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2015
Estimated Enrollment :
9 Patients enrolled
Trial Details
Trial ID
NCT01498835
Start Date
February 1 2012
End Date
February 1 2015
Last Update
August 28 2017
Active Locations (2)
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1
Helios Klinikum Bad Saarow
Bad Saarow, Germany, 15526
2
University Medical Center Mannheim
Mannheim, Germany, 68167