A phase IB/II study of sunitinib in combination with neoadjuvant radiation in patients with resectable soft tissue sarcoma
- Conditions
- Soft tissue sarcomaCancer - Sarcoma (also see 'Bone') - soft tissue
- Registration Number
- ACTRN12608000474358
- Lead Sponsor
- Peter MacCallum Cancer Centre
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 26
Histologically confirmed soft-tissue sarcoma suitable for neoadjuvant radiotherapy and surgery; minimum age 16 years; Eastern Cooperative Oncology Group (ECOG) performance status =1 or less; life expectancy of greater than 6 months; patients must have normal organ and marrow function; no evidence of a bleeding or thrombotic tendency, and no evidence of arterial or venous thrombosis; not pregnant or breastfeeding; and the ability to give written informed consent.
Soft-tissue sarcoma located in sites where radiotherapy is associated with significant exposure of abdominal viscera; patients with other invasive malignancies, with the exception of non-melanoma skin cancer, in the last 5 years; patients receiving any other therapeutic investigational agents; patients who are receiving concurrent treatment with any other anti-cancer therapy; evidence of distant metastases; uncontrolled intercurrent illness; patients who are pregnant or breast feeding.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method To determine the maximum dose of sunitinib at which the combination of sunitinib and radiotherapy pre-operatively is safe and tolerable. Patients will be closely monitored for adverse events during the course of treatment. Dose limiting toxicities have been defined based on Common Terminology Criteria for Adverse Events (CTCAE) and will be reported immediately if observed. If two or more dose-limiting toxicites are observed in patients the Sunitinib dose during radiotherapy may be modified for subsequent patients.[Baseline; post-2 weeks sunitinib only administration; post-sunitinib and radiotherapy combination treatment; 12 weeks post-surgery]
- Secondary Outcome Measures
Name Time Method To estimate response rates for the combination of sunitinib and radiotherapy. Response rates will be measured by each of the following three metrics: i) Response Evaluation Criteria in Solid Tumors (RECIST); ii) functional imaging with 18F-Deoxyglucose Positron emission tomography (FDG-PET); and iii) histologic (i.e. pathologic) response.[Baseline; post-2 weeks sunitinib only administration; post-sunitinib and radiotherapy combination treatment; and at surgery]